ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears

ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears Ian A Harris, Richard S Page, Rachelle Buchbinder, Ville Äärimaa, and 19 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5040867/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Apr, 2025 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full thickness degenerative rotator cuff tears. Methods The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40–75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including – as indicated – bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists study staff and statisticians will all be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery. Discussion The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears. Trial registration The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599). Clinical trials rotator cuff shoulder surgery placebo Administrative information This protocol has been prepared according to the SPIRIT statement and the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/). Title {1} ARC (Australian Rotator Cuff) trial: a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears Trial registration {2a} The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599) Trial registration {2b} All items from the World Health Organization Trial Registration Data Set are available in the registry (UTN U1111-1251-6599), and distributed within text of manuscript where applicable Protocol version {3} This publication is a summary of version 16 of the study protocol dated 15 July 2024 Funding {4} The study is funded by the Whitlam Orthopaedic Research Centre, a not-for-profit charitable gift recipient organization. The funding organisation has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Author details {5a} All protocol contributors and affiliations are listed above, under “Names of protocol contributors” and “Institutions”. IAH is the Principal Investigator and conceived the study and drafted the protocol. All authors contributed to the study protocol. Name and contact information of the trial sponsor {5b} Research Grants and Contracts, Division of Research and Enterprise Level 3, Rupert Myers Building (South Wing) UNSW SYDNEY 2052, NSW, Australia E: [email protected] Roles of sponsor {5c} Study sponsor has no role in or authority over study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. The study is sponsored by UNSW Sydney. The sponsor has delegated to the Principal Investigator (IAH) the role of study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Introduction Background and rationale {6a} Rotator cuff pathology is common and increases with age, affecting many people over the age of 45 years and most people over the age of 60, with more than half having shoulder pain. 1,2 Shoulder pain is common (22% prevalence in adults) and makes up approximately 1% of all primary care presentations, 85% of which will have rotator cuff pathology. 3-6 Large acute tears may occur as a result of significant trauma (such as a shoulder dislocation) but most tears are not acute. The two most common surgical procedures for patients with shoulder pain are subacromial decompression and rotator cuff repair (suturing and anchoring the torn tendon to the humeral head insertion), either separately or in combination. Subacromial decompression is performed arthroscopically and involves removal of bursal tissue and the bony under-surface of the acromion to decompress the passage of the rotator cuff tendons through the subacromial space. The effectiveness of subacromial decompression as stand-alone treatment for rotator cuff disease (excluding full thickness tears) has been called into question based upon high-certainty evidence that it provides no clinically important benefits over placebo in pain or function 7-9 with a BMJ guideline panel making a strong recommendation against use of this surgery for shoulder pain. 10 The Australian Rotator Cuff (ARC) study investigates the effectiveness of a strategy to surgically repair full thickness, non-acute tears. Such lesions make up over 75% of all tears 11 and are often treated with surgery following failed non-operative management. Rotator cuff repair is the most common surgical procedure performed in the shoulder, with rates increasing. 12-17 The rationale for surgical repair is to improve symptoms (pain and function) which are believed to arise from the tear and to prevent the tear from becoming larger. In contrast to subacromial decompression, results from a randomised placebo-controlled trial of rotator cuff repair have not been reported. A 2019 Cochrane review from 2019 that included nine randomised trials involving 1007 participants comparing rotator cuff repair with or without decompression to other active interventions noted that all trials were at high risk of bias, most notably for selection and performance bias due to failure to blind both participants and study personnel to treatment allocation. 18 The review found low certainty evidence that rotator cuff repair provides little or no benefit in pain, function and quality of life compared to non-operative treatment and no added benefit over subacromial decompression alone. In addition, there are high rates of re-tears (following repair) at one to two years, 19-21 the structural integrity of the cuff after surgical repair does not correlate with clinically important differences in pain or function, and many tears do not progress if left unrepaired. 22-24 Uncertainty around the effectiveness of surgical rotator cuff repair is also reflected in variation in rates of surgery and surgeon preference. 25,26 As a result of practice variation and evidence uncertainty, high quality trials for rotator cuff tears were listed in the top ten research priorities for shoulder surgery in a multidisciplinary priority setting exercise using the James Lind Alliance Priority Setting Partnership methods in 2016. 27 Objectives {7} The ARC trial aims to determine the effectiveness, safety and cost-effectiveness of arthroscopic shoulder surgery with rotator cuff repair compared with arthroscopic shoulder surgery without rotator cuff repair, for improving shoulder pain and function, and quality of life in people with symptoms attributed to non-acute, full thickness rotator cuff tears. The study hypothesis is that in people aged 45 to 75 years with at least 6 months of shoulder symptoms and a complete, surgically reparable rotator cuff tear, arthroscopic surgery with repair of the tear is superior to arthroscopic surgery without repair in improving shoulder pain and function at 6 months post-surgery. Trial design {8} The ARC trial is a multicentre, two-parallel group, blinded, randomised, placebo-controlled superiority trial. All eligible patients at participating sites will be approached to participate. Those who consent will undergo shoulder arthroscopy to confirm eligibility (size and location of rotator cuff tear) and address other pathology (e.g. acromial pathology, see below), and then randomised intra-operatively by online randomisation service to either arthroscopic surgical rotator cuff repair or no repair in a 1:1 ratio. Concomitant arthroscopic procedures (see “Interventions”, below) will be performed as per current usual practice and prior to randomisation. Patient involvement The trial was discussed in a focus group of rotator cuff surgery patients. The consumers understood the need for the trial and were comfortable with the use of placebo surgery. Furthermore, they were comfortable with the use of a common rehabilitation protocol, follow up by a surgeon not involved in their operation, and maintenance of blinding. They considered it important to have no costs to the participants (as planned) and felt that the closer follow up associated with trial participation, the avoidance of any costs, and contributing to the evidence that will assist with the management of future patients were strong drivers to participate. The trial protocol has also been reviewed by the Consumer Advisory and Scientific Committees of the Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network and feedback has been incorporated. The ANZMUSC Executive Committee has endorsed the trial. The study includes two people with shoulder pain as investigators. Methods: participants, interventions and outcomes Study setting {9} The study setting will parallel usual practice. Operating surgeons will be specialist shoulder surgeons. The consultations and surgery will be performed in healthcare sites (public and/or private) normally used by the study surgeons, including all usual personnel (physiotherapists, nurses, trainee surgeons, anaesthetists etc.). Eligibility criteria {10} Inclusion Criteria Age 45 – 75 years inclusive (older patients are usually treated non-operatively and younger patients are less likely to have non-acute tears) At least 6 months duration of shoulder symptoms Complete tear of supraspinatus tendon on Magnetic Resonance Imaging (MRI) Rotator cuff repair is considered the primary reason for surgery English speaking Available for post-operative rehabilitation and follow up for at least 6 months Complete tear of the supraspinatus tendon confirmed at arthroscopy as being 1 to 4cm in anteroposterior length with or without extension into infraspinatus and allowing tearing of the superior 1/3 of subscapularis tendons and considered arthroscopically reparable Exclusion Criteria Pregnancy Tear extending beyond superior 1/3 of subscapularis tendon Prior rotator cuff surgery of the affected shoulder Stage 3 or higher fatty atrophy of the rotator cuff muscles and a positive Tangent sign (relative contraindication to repair due to low success rate) 28 Glenohumeral osteoarthritis (Outerbridge Grade III or higher measured during arthroscopy) 29 or loss of joint space or osteophyte on pre-operative imaging Frozen shoulder (>50% loss global passive range) and/or proposed capsular release A traumatic tear (an acute event that is more than a fall from standing height) that has occurred within the last six months Current use of oral glucocorticoids, immunosuppressants; there will be no exclusion based on prior therapies Rheumatoid arthritis or other autoimmune inflammatory arthropathy Shoulder instability (history of dislocation) Osteonecrosis of the humeral head Resident of a residential aged care facility Shoulder condition covered by workers’ compensation insurance (this is associated with poor results and may bias against any effectiveness of surgery 30 ) Limited English proficiency or cognitive impairment precluding fully informed consent Who will take informed consent {26a} Potential participants will be identified from the participating sites (private and public settings) where study surgeons work. If the surgeon considers rotator cuff repair surgery to be indicated and the cuff repair to be the main reason for surgery, patients will be approached to participate, informed of the trial, given written information and contacted by the research team prior to deciding whether to participate. Consent will be collect using an online consent form. Additional consent provisions for collection and use of participant data and biological specimens {26b} No additional consent procedures will be used and no specimens will be taken as part of the study. Interventions Explanation for the choice of comparators {6b} By comparing arthroscopic surgery with rotator cuff repair to arthroscopic surgery without rotator cuff repair, the only difference between study groups will be the presence or absence of the active component of the intervention being tested (i.e., rotator cuff repair). Isolating the active ingredient of the procedure being studied allows the study to provide the least biased estimate of efficacy of rotator cuff repair in the study population. Intervention description {11a} The active intervention is arthroscopic shoulder surgery with rotator cuff repair. The surgical technique will be according to surgeon preference. The type of repair (e.g., double row versus single row) will be recorded. Surgery will be performed within 90 days of consent where possible, and baseline data will be collected within 42 days of surgery in all cases. The control intervention (placebo) is arthroscopic shoulder surgery without rotator cuff repair. In both groups, concomitant procedures will be allowed prior to intra-operative randomisation. For both groups, anaesthesia and surgical set-up will be according to local standard practice. Arthroscopy will use standard portals with full visualisation to allow diagnostic arthroscopy. Exposure of the rotator cuff tear will be sufficient to allow visualisation, measurement and recording (site, size and reparability) of the tear to confirm eligibility, and subsequent repair if randomised to that arm of the trial. At the conclusion of the procedure, the arm will be placed in a shoulder immobiliser sling in both groups. Intra-operative images will be taken as per usual practice and will be used for inclusion criteria and treatment verification. Allowing concomitant procedures more closely resembles usual practice, making the study more pragmatic and generalisable. It also increases acceptability by participants and surgeons. Further, by retaining all elements of the procedure with the exception of the active ingredient of the study intervention (rotator cuff repair), the requirements for high-fidelity placebo surgery are met. 31 The permitted concomitant procedures will be bursal debridement, acromioplasty, biceps tendon tenodesis or tenotomy, and acromioclavicular joint resection. Concomitant procedures will be performed prior to randomisation and will not require any change to the post-operative rehabilitation . Concomitant procedures will be balanced between groups (through randomisation alone or the minimisation algorithm used in the randomisation process). Post-operative analgesia (including nerve blocks) will be as per usual care for each treating surgeon. Whilst the focus of this trial is the surgery, participants and their physiotherapists will receive written guidance on good quality post-operative rehabilitation which includes a graded program divided into phases, informed by recommendations from the recent consensus statement of the American Society of Shoulder and Elbow Therapists 32 and the protocol of the current ACCURATE placebo RCT. 33 Physiotherapists will be guided to follow four phases of rehabilitation that represent a consensus of current best practice recommendations: Phase 1 (0-4 weeks): arm placed in sling, passive and assisted range of motion (ROM). Phase 2 (5-8 weeks): active-assisted ROM unloading rotator cuff. Phase 3 (9-12 weeks): active-unloaded exercises, isometric cuff strengthening. Phase 4 (13-20 weeks): active ROM, dynamic strengthening exercises for cuff and scapula. Physiotherapists will be guided to progress to each phase dependent on time and milestone achievement. Participants will be followed-up directly (electronically or by telephone/ mail) for study data collection at 1-2 weeks, 6-8 weeks, 3 months, 6, 12 month and 24 months. Five and ten year follow up will be subject to additional funding. Participants will be followed in person by a blinded surgeon other than their operating surgeon at 1-2 weeks, 6-8 weeks, 3 months and 6 months. If further surgical reviews are required beyond 6 months, this will be dependent on the participant’s post-surgical progress. Criteria for discontinuing or modifying allocated interventions {11b} The interventions are one-off procedures and cannot be discontinued or modified after being provided. Surgeons are allowed to modify the technique of rotator cuff repair according to usual preference. Strategies to improve adherence to interventions {11c} Participant adherence to the interventions is not applicable as the intervention is applied during their surgical procedure, under anaesthetic. Surgeon adherence will be monitored by inspection of intra-operative imaging. Participant adherence to the post-operative physiotherapy program will be monitored by surveying all participants regarding attendance. Relevant concomitant care permitted or prohibited during the trial {11d} Concomitant surgical procedures are listed above, under “Intervention description” and these will be performed prior to randomisation. All participants (in both groups) will undergo routine care associated with rotator cuff repair surgery, including anaesthesia, post-operative pain relief and post-operative rehabilitation. Provisions for post-trial care {30} Participants will be managed by the post-operative surgeon and physiotherapists according to usual care, including the management of any complications. Outcomes {12} Baseline data (Table 1) will be collected up to 6 weeks prior to surgery. Surgical data (Table 2) will be collected at the time of surgery. The primary outcome is the Western Ontario Rotator Cuff Index (WORC) measured at 6 months post-surgery. The WORC is a self-administered condition-specific health questionnaire specifically designed for rotator cuff disease and its treatment. 34 It consists of 21 questions encompassing 5 domains: symptoms, sport and recreation, work, social function and emotions and can be presented in a summary score on a scale from zero (no symptoms or limitations) to 2100 (each question is scored on a 0-100 scale). The raw score will be converted to the final WORC, which ranges from 0 to 100, with higher scores indicating worse pain and function. The final WORC score is calculated by subtracting the raw WORC score from 2100 and dividing the result by 21 to create a score out of 100. The WORC was chosen because it is widely used for studies of rotator cuff repair, has been validated in that population, has better internal consistency, reliability, content validity and responsiveness than other shoulder outcome tools, 35 has no floor or ceiling effect, 36 and is the primary outcome in the current (ACCURATE) placebo rotator cuff repair trial (thereby enabling direct comparison). 33 WORC was recommended by the surgeon investigators and was developed with direct patient input. 34 Secondary outcomes are: Health-related quality of life: EuroQoL 5 Domain (EQ5D-5L) & EuroQoL Visual Analogue Scale (EQ-VAS), a validated generic quality of life questionnaire. Comprises of five questions on mobility, self-care, pain, usual activities, and psychological status with five possible answers for each item and a VAS to indicate general health status. Shoulder patient global perceived effect: a 5-point Likert Scale measuring “How is your shoulder now compared to before the surgery?” : much worse, a little worse, about the same, a little better, much better. Shoulder pain at rest: a Numerical Rating Scale from 0 to 10 with ‘0’ representing no pain and ‘10’ representing the worst pain imaginable in the preceding week. Shoulder pain with activity: a Numerical Rating Scale from 0 to 10 with ‘0’ representing no pain and ‘10’ representing the worst pain imaginable in the preceding week. Work status : normal duties, restricted duties/hours, not working. Post-operative physiotherapy attendance at 6 months : 0-4 sessions, 5-9 sessions, equal to or greater than 10 sessions. Presence and size of complete rotator cuff tear on MRI at 12 months: measured in centimetres to one decimal place Acromio-humeral distance on MRI at 12 months: measured in millimetres Osteoarthritis on MRI at 12 months: according to modified Samsilon & Prieto Score. 37 Muscle wasting of rotator cuff on MRI at 12 months: measured using Goutallier classification (Stage 0 – 4). 28 Complications: death, frozen shoulder, infection requiring treatment, repeat surgery. The outcomes include the four mandatory clinical trial domains (pain, function, patient global assessment of the shoulder, and adverse events including death) and the majority of the four ‘important but optional’ domains (participation (recreation/work), sleep, emotional wellbeing and condition- specific pathophysiological manifestations) in the OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders. 38 Table 1. Baseline variables Variable Unit of measurement Age at time of consent Years Sex Male, female Hand dominance Left, right Educational attainment No schooling, primary, high school, vocational training, bachelor, masters, doctorate, other Medical history High blood pressure, diabetes, osteoporosis, neck pain, heart condition, stomach disorder, bowel or intestinal disorder, depression anxiety, chronic respiratory illness, kidney disease Current medications Yes, no WORC 0-100, higher scores representing better pain and function EQ-5D-5L Numeric EQ-VAS Numeric Shoulder pain at rest Numeric rating scale 0-10 Shoulder pain with activity Numeric rating scale 0-10 Height Centimetres Weight Kilograms Current smoker Yes, no Duration of symptoms 6-12 months, more than 12 months Work status Normal duties, restricted duties/hours, not working Strength tests (Geelong sites) Shoulder abduction & external rotation power (Newtons) Size of complete tear on MRI Centimetres to one decimal place (mm) in antero-posterior plane Table 2. Surgical variables Variable Units of measurement ASA grade I, II, II, IV Date of surgery Date Length of tear Centimetres to one decimal place (mm) in antero-posterior (length) and medial-lateral (width) planes Involvement of infraspinatus Yes, no Biceps condition Normal, tendinosis, subluxation, ruptured (choose highest applicable) Biceps surgery None, tenotomy, tenodesis Biceps fixation None, screw, button Glenoid osteoarthritis Outerbridge grade 0, 1, 2, 3, 4 Humeral osteoarthritis Outerbridge grade 0, 1, 2, 3, 4 Cuff repair No repair, repair (single vs double row, number of anchors) Participant timeline {13} Table 3 provides the schedule of participant contact. Table 3. Schedule of study procedures Enrolment Baseline Visit 1 -Surgery PS-1 1-2 weeks PS-2 6-8 weeks PS-3 3 months PS-4 6 months PS-5 12 months PS-6 24 months PS-7 5 years PS-8 10 years Informed Consent X Inclusion / Exclusion criteria X X Copy of clinical MRI X X # Medical history/demographics X Surgery / randomisation X Operation reports X Surgeon follow up X X X X X X Blinding fidelity X X X X Shoulder strength X X X Work status X X X Physiotherapy attendance X Outcome questionnaires X X X X X X AE/ SAE /Complications X X X X X X X* X* PS – Post Surgery # 11-18 months * only Complications will be recorded (not adverse events) Sample size {14} The sample size used during initial trial registration was based on detecting a 0.5 standard deviation (SD) difference between groups. Recent research has reported the Smallest Worthwhile Effect (SWE) for the ARC study, specifically comparing the two groups used in this trial. 39 The median SWE for improvement in pain and function within six months for rotator cuff repair surgery over subacromial decompression alone was 40% and the lower limit of the interquartile range was 20%. We chose to power the study based on the lower estimate of 20% improvement in the raw WORC score, which converts to 14% change in the final (0-100) WORC based on baseline values in this population (both the SWE study and the ARC study to date). The minimum important difference in the WORC has been reported at similar levels of 13 and 14 points. 40-42 The SD of the WORC post-rotator cuff tear has been estimated at 17-20. 43-45 Using a 14 point between-group difference in the WORC at 90% power and a p value of 0.05 and assuming a conservative estimate of 20 for the SD, 86 participants are required (43 in each group). Therefore, we aim to recruit until we have primary outcome (6 months) data for 86 participants excluding crossovers up to 6 months. Recruitment {15} At least 8 centres will be included to ensure achievement of the sample size. Surgeons will be asked to complete screening logs and complete screening forms for potential participants. Monthly newsletters will be provided to investigators and these will include recruitment rates and targets. Assignment of interventions: allocation Sequence generation {16a} Randomisation will occur by use of the computer-generated interactive web response system of the Griffith University Randomisation Service. Randomisation will be 1:1 between groups and will use the technique of minimisation to balance groups for age, surgeon and concomitant procedures. Concealment mechanism {16b} Use of the online interactive web response system will ensure concealment of the allocation until it is assigned. Implementation {16c} The allocation sequence will be computer-generated and allocated by the interactive web response system. The system will be accessed by the operating surgeon or their delegate intra-operatively. The intervention will be assigned by the operating surgeon. Assignment of interventions: blinding Who will be blinded {17a} Operating surgeons will not be blinded. Participants, the post-surgical care team, including follow-up surgeons, rehabilitation physiotherapists and the study management team will remain blinded for the duration of the study. Participants will be followed up by a different surgeon to the operating surgeon (a blinded trial surgeon at the same site). Maintenance of blinding will be supported by information provided in patient study cards (to be carried with participants and presented to treating practitioners), and letters provided to treating general practitioners and physiotherapists informing them of the trial procedures. Operation reports will be standardised as “Treatment according to the ARC study protocol”. An unblinded operation report (standard report) will be produced and kept by the treating surgeon and only released if unblinding is deemed necessary (e.g. further surgery required). Blinding fidelity will be tested during follow-up (see Table 3 for timing) by asking each participant which group they believe they are in: rotator cuff repair, no rotator cuff repair, or unsure. The statisticians responsible for the analyses will program all the analyses indicated in the statistical analysis plan using a masked treatment allocation performed by an independent statistician. The statisticians will provide the Writing Committee with blinded results from the analyses, with the two arms labelled A and B. The Writing Committee will then meet to consider the interpretations of the results until a consensus is reached for each alternative interpretation (based on the two possible treatment allocations), prior to unblinding. Procedure for unblinding if needed {17b} If the participant’s treating clinicians at any time during the study period deems a change in treatment is needed and unblinding may be necessary, the Trial Management Committee will decide if the patient will be unblinded. Participants will be encouraged to remain blinded for the first two years, after which time those who wish to know their treatment allocation will be unblinded. Data collection and management Plans for assessment and collection of outcomes {18a} Data will be collected directly in a REDCap 46,47 database. Participants will be directed to the REDCap interface for consent and entering survey responses. Surgical data will be entered into REDCap by the research team based on case report forms completed intra-operatively by the surgeons. Plans to promote participant retention and complete follow-up {18b} The use of electronic links to online surveys is expected to improve participant follow-up. Participants who do not respond to electronic (email and text) reminders will be contacted by telephone but directed to enter the data directly where possible. Follow-up will continue regardless of protocol adherence. Data management {19} The REDCap database is provided, hosted and backed up regularly by the University of New South Wales, on a secure network. Data will be password protected and with separate access, depending on the study role, with no one able to access the random treatment allocation except the unblinded statistician responsible for providing reports to the independent DSMC and an assigned unblinded study team member. Data access will be restricted to the TMG that will oversee day-to-day trial management. The SC will oversee study progress, data collection and integrity and will approve the statistical analysis plan and research protocol. The integrity of trial data will be monitored by regular (monthly) review of data for omissions and errors. The database will be constructed with restricted ranges to reduce errors in data entry. Confidentiality {27} Personal information in the database will be password protected on a secure network. No identifying information will be used in any analysis, report or publication. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Biological specimens will not be collected in this study. Statistical methods Statistical methods for primary and secondary outcomes {20a} The study will be reported according to the CONSORT statement and will include a CONSORT flowchart. 48 Baseline data will be described for each group separately and the total cohort. Baseline differences between groups will not be formally tested. The primary outcome (difference in WORC between groups at 6 months) will be analysed on an intention to treat basis using multivariable regression, adjusted for baseline WORC. The effect of the intervention will be estimated as the adjusted mean difference and its 95% confidence interval. The p value for the primary analysis will be reported based on the null hypothesis of no difference in shoulder pain and function at 6 months post-surgery between the two groups. Other outcomes and timepoints for the primary outcome will be reported using regression adjusted for baseline scores where applicable. Dichotomous outcomes (e.g. complications) will be reported using logistic regression with no adjustments. A secondary analysis including all WORC measurements will be conducted using a repeated-measures linear mixed model including the treatment allocation, the visit (timepoint), the treatment-by-visit interaction, and baseline WORC. A random subject effect or a repeated effect will be included to model within-subject correlations. A detailed Statistical Analysis Plan will be developed and published prior to unblinding and database lock. Eligible patients who decline inclusion in the randomised trial will be invited to participate in a parallel observational study. Those treated surgically will be treated as per the intervention arm of the randomised trial. The non-operative group will be treated as per usual care. The observational cohort will be followed as per the randomised study (time points and outcomes) with the following differences: Baseline assessments must be completed within six weeks of enrolment, rather than within six weeks of the scheduled surgery. Adverse events will not be collected as participants will not be assigned any study intervention and will be provided with unblinded ‘usual care’. Pre-determined complication outcomes as specified in Secondary Outcomes will still be obtained. Data from this observational cohort will provide information on the generalisability of the results of the randomised trial and allow comparison between the control group and matched non-operative care. Interim analyses {21b} Unless requested by the DSMC, no interim analysis is planned. Methods for additional analyses (e.g. subgroup analyses) {20b} Exploratory analyses will be performed to analyse the effect of tear size, concomitant procedures, surgeon and repair type on the primary outcome (interaction). Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} As randomisation occurs intra-operatively and the primary outcome is at 6 months, no crossovers and minimal loss to follow up are expected. A per-protocol analysis and imputation for missing data will only be performed if crossovers or loss to follow-up at six months (primary end-point) are greater than 5%. Plans to give access to the full protocol, participant level-data and statistical code {31c} The protocol will be published and the full protocol made available on request. De-identified study data and the statistical code will be made available upon reasonable request, after publication. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} The Steering Committee oversees overall study design and conduct and comprises all investigators based in Australia. The Steering Committee will meet at least every 6 months. The coordinating centre at the Whitlam Orthopaedic Research Centre, supported by the Ingham Institute for Applied Medical Research and the University of New South Wales, oversees the trial’s overall management, including protocol adherence, site coordination, ethics, and data management. It provides organisational support and facilitates communication between trial sites and oversight committees. The central trial coordinator supports the trial’s daily operations. The Trial Management Group (TMG) oversees day-to-day trial management and consists of 5 of the study’s investigators, including the Coordinating Principal Investigator (CPI) the study’s two second co-investigators and the central trial coordinator. The TMG initially met monthly during trial set-up, and will meet every second month during recruitment and until trial close-out. The TMG review trial conduct, focusing on recruitment progress, data management, protocol adherence, safety reporting, and site performance. Any protocol or site-specific issues identified will be addressed through corrective actions to ensure compliance and trial integrity. Composition of the data monitoring committee, its role and reporting structure {21a} The Data Safety and Monitoring Committee (DSMC) oversees data management and safety and comprises a statistician, a shoulder surgeon and a rheumatologist. The DSMC will provide medical oversight and expertise concerning recommendations for the continuation, modification, or termination of the trial. The DSMC will be independent of the study sponsor, will not be involved in the study, will declare any competing interests and will not benefit in any way from the results of this trial. The DSMC will monitor AEs and SAEs to ensure the safety of participants. The DSMC will meet annually or as required to provide study oversight. The DSMC charter is available from the corresponding author upon reasonable request. Adverse event reporting and harms {22} Adverse events (AE) (non-serious AEs / Serious Adverse Events (SAE)/ Unexpected Related Serious Adverse Events), Significant Safety Issues and Urgent Safety Measures) will be collected, monitored and reported accordingly to the Sponsor’s Delegate, relevant ethic committee(s) and Research Governance Office(s). The safety reporting procedures will follow the latest version of The ARC Trial Safety Management Plan. An independent Data Safety and Monitoring Committee (DSMC) will conduct an annual review of the trial data to assess participant safety and study integrity, providing recommendations on whether to continue, modify, or stop the trial. The DSMC will have access to unblinded data and data on the primary outcome, AEs (after coding) and SAEs. Data on complications will be recorded as outcomes and the DSMC will assess their severity and frequency. Frequency and plans for auditing trial conduct {23} Regular central monitoring of recruitment rates, withdrawals, protocol deviations, safety reports and data quality concerns by the study officer is planned and will be discussed by the Trial Management Group and/or the Steering Committee or DSMC meetings, with the outcomes of all meetings documented via meeting minutes. A yearly monitoring report will be submitted to the trial Sponsor. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Any protocol amendments are approved by the Trial Management Group (TMG), which is chaired by the Sponsor’s delegate, the Coordinating Principal Investigator. All significant changes to the protocol will be submitted to the relevant human research ethics committee and communicated to all sites and investigators once approved. All protocol amendment submission and approvals are filed in the Investigator Site Files as per GCP. Any protocol changes are updated in the ANZCTR registry. Dissemination plans {31a} The Writing Committee will draft all manuscripts prior to review by other investigators and comprises IAH, RP, RB, JD. Authorship of all manuscripts will be granted according to ICJME guidelines. Study results will be published in a scientific journal and presented at international meetings. Media coverage will be promoted and sought to more widely communicate the results. The trial involves many opinion leaders in shoulder surgery nationally and internationally and has been endorsed by the Shoulder and Elbow Society of Australia (surgeons) and ANZMUSC (a musculoskeletal clinical trials network of clinicians, researchers and consumers); working with members of these groups will facilitate incorporation into practice guidelines and the day-to-day practice of clinicians. Discussion The ARC trial will generate new, low bias evidence on the efficacy of rotator cuff repair for patients with chronic shoulder pain and non-acute (degenerative) rotator cuff tears by using a high-fidelity placebo control to isolate the active ingredient of the surgery (cuff repair) and by maximizing blinding of patients, carers, health care providers and investigators. Trial status This manuscript is based on Version 16 of the protocol (15 July 2024). Recruitment began in April 2021 and is expected to be complete by April 2026. Abbreviations AE Adverse event ANZMUSC Australia and New Zealand Musculoskeletal Clinical Trials Network ARC Australian Rotator Cuff (trial) DSMC Data Safety and Monitoring Committee EQ-5D-5L EuroQol 5-domain, 5-level quality of life survey EQ-VAS EuroQol visual analogue scale MRI Magnetic resonance imaging RCT Randomised controlled trial SAE Serious adverse event TMG Trial Management Group WHO World Health Organization WORC Western Ontario Rotator Cuff Index Declarations Acknowledgements Not applicable. Author contributions {31b} IAH is the Principal Investigator and conceived the study and drafted the protocol. JD is the study statistician and contributed to the statistical analysis. All authors contributed to and approved the final version of the manuscript. Funding {4} The study is funded by the Whitlam Orthopaedic Research Centre, a not-for-profit charitable gift recipient organisation. The funding organisation has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Availability of data and materials {29} All investigators will have access to the final dataset. There are no contractual agreements limiting access for investigators. The final dataset will be available after study publication upon reasonable request. The protocol and statistical analysis plan will be published. Ethics approval and consent to participate {24} The study protocol version 6.0 28 May 2020 was approved by the Human Research Ethics Committees of the South Western Sydney Local Health District on 15 June 2020 (reference number 2020/ETH00754 ) and St John of God Health Care on 18 August 2020 (reference number 1704). Each update to the protocol has been approved by the relevant ethics committee. The study will be performed according to the National Statement on Ethical Conduct in Human Research. 49,50 As per the National Statement (2018 and 2023, section 3.1.5), placebo controlled trials are ethically acceptable where the current standard of care includes the absence of the intervention being tested and there is no risk of significant harm in the absence of the intervention. All investigators will undergo training in Good Clinical Practice for clinical trials and will complete a study start up site or remote visit that involves training of the site principal investigator and all delegated personnel, on the approved versions of the trial protocol, standard operating procedures and/or relevant essential documents. The protocol and a statistical analysis plan will be published in an open-access journal. The protocol complies with SPIRIT guidelines 51 and the study will be reported according to the CONSORT guidelines. 48 Consent for publication {32} A model consent form and participant information sheet have been provided as Supplementary Material. Competing interests {28} The authors declare that they have no competing interests. References Sher JS, Uribe JW, Posada A, et al. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1995;77:10-5. Yamamoto A, Takagishi K, Osawa T, et al. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg 2010;19:116-20. Chard MD, Hazleman R, Hazleman BL, et al. Shoulder disorders in the elderly: A community survey. Arthritis & Rheumatism. 1991;34:766-69. doi: doi:10.1002/art.1780340619. Hill CL, Gill TK, Shanahan EM, et al. Prevalence and correlates of shoulder pain and stiffness in a population-based study: the North West Adelaide Health Study. 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Trends in rotator cuff repair rates and comorbidity burden among commercially insured patients younger than the age of 65 years, United States 2007-2016. JSES Rev Rep Tech 2021;1:309-16. Karjalainen TV, Jain NB, Heikkinen J, et al. Surgery for rotator cuff tears. Cochrane Database Syst Rev. 2019;12:CD013502. Kukkonen J, Joukainen A, Lehtinen J, et al. Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results. Bone Joint J. 2014;96:75-81. Lambers Heerspink FO, van Raay JJ, Koorevaar RC, et al. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial. J Shoulder Elbow Surg. 2015;24:1274-81. Moosmayer S, Lund G, Seljom U, et al. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up. J Bone Joint Surg Br. 2010;92:83-91. Jeong HJ, Nam KP, Yeo JH, et al. Retear After Arthroscopic Rotator Cuff Repair Results in Functional Outcome Deterioration Over Time. Arthroscopy. 2022;38(8):2399-412 Kim YS, Kim SE, Bae SH, et al. Tear progression of symptomatic full-thickness and partial-thickness rotator cuff tears as measured by repeated MRI. Knee Surg Sports Traumatol Arthrosc. 2017;25:2073-80. Russell RD, Knight JR, Mulligan E, et al. Structural integrity after rotator cuff repair does not correlate with patient function and pain: a meta-analysis. J Bone Joint Surg Am. 2014;96(4):265-71. Dunn WR, Schackman BR, Walsh C, et al. Variation in orthopaedic surgeons' perceptions about the indications for rotator cuff surgery. J Bone Joint Surg Am. 2005;87:1978-84. Wang A, Mackie K, Bain G, et al. Variation in treatment of rotator cuff injury within a subspecialist shoulder society. In: SESA, ed. Shoulder and Elbow Society of Australia (SESA) Biennial Meeting. Perth, 2018. Rangan A, Upadhaya S, Regan S, et al. Research priorities for shoulder surgery: results of the 2015 James Lind Alliance patient and clinician priority setting partnership. BMJ Open. 2016;6:e010412. Somerson JS, Hsu JE, Gorbaty JD, et al. Classifications in Brief: Goutallier Classification of Fatty Infiltration of the Rotator Cuff Musculature. Clin Orthop Relat Res. 2016;474(5):1328-32. Slattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018;476:2101-04. Harris I, Mulford J, Solomon M, et al. Association between compensation status and outcome after surgery: a meta-analysis. JAMA. 2005;293:1644-52. Beard DJ, Campbell MK, Blazeby JM, et al. Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet. 2020;395:828-38. Thigpen CA, Shaffer MA, Gaunt BW, et al. The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016;25:521-35. Ryosa A, Kukkonen J, Bjornsson Hallgren HC, et al. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019;9:e025022. Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003;13:84-92. Huang H, Grant JA, Miller BS, et al. A systematic review of the psychometric properties of patient-reported outcome instruments for use in patients with rotator cuff disease. Am J Sports Med. 2015;43:2572-82. de Witte PB, Henseler JF, Nagels J, et al. The Western Ontario rotator cuff index in rotator cuff disease patients: a comprehensive reliability and responsiveness validation study. Am J Sports Med. 2012;40:1611-9. Buscayret F, Edwards TB, Szabo I, et al. Glenohumeral arthrosis in anterior instability before and after surgical treatment: incidence and contributing factors. Am J Sports Med. 2004;32:1165-72. Ramiro S, Page MJ, Whittle SL, et al. The OMERACT core domain set for clinical trials of shoulder disorders. J Rheumatol. 2019;46:969-75. Hansford HJ, Buchbinder R, Zadro JR, et al. The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study. medRxiv, 2024. https://www.medrxiv.org/content/10.1101/2024.07.24.24310953v1. Accessed 5 September 2024. Braun C, Handoll HH. Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears. Musculoskelet Sci Pract. 2018;35:30-3. Jones IA, Togashi R, Heckmann N, et al. Minimal clinically important difference (MCID) for patient-reported shoulder outcomes. J Shoulder Elbow Surg. 2020;29:1484-92. Ekeberg OM, Bautz-Holter E, Keller A, et al. A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease. J Clin Epidemiol. 2010;63:575-84. Bejer A, Płocki J, Probachta M, et al. A comparison study of the Western Ontario Rotator Cuff Index, and the Constant–Murley Score with objective assessment of external rotator muscle strength and pain in patients after arthroscopic rotator cuff repair. Int J Environ Res Public Health 2023;20:6316. Herring MJ, White M, Braman JP. The WORC Index and Predicting Treatment Failure in Patients Undergoing Primary Arthroscopic Rotator Cuff Repair. Orthop J Sports Med. 2019;7(7):2325967119859518. Sugaya H, Maeda K, Matsuki K, et al. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005;21:1307-16. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377-81. Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: building an international community of software partners. J Biomed Inform. 2019;95:103208. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. National Health and Medical Research Council, Australian Research Council, Universities Australia. National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Canberra: National Health and Medical Research Council, 2018. National Health and Medical Research Council, Australian Research Council, Universities Australia. National Statement on Ethical Conduct in Human Research. Canberra: National Health and Medical Research Council, 2023. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200-207. Supplementary Files MasterPISRCTv517July2022clean.docx Cite Share Download PDF Status: Published Journal Publication published 02 Apr, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Accept 19 Mar, 2025 Reviewers agreed at journal 18 Mar, 2025 Reviewers invited by journal 18 Mar, 2025 Editor assigned by journal 18 Mar, 2025 First submitted to journal 17 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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08:25:44","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":65175,"visible":true,"origin":"","legend":"","description":"","filename":"MasterPISRCTv517July2022clean.docx","url":"https://assets-eu.researchsquare.com/files/rs-5040867/v1/842bfab3837c6c13605d32f5.docx"}],"financialInterests":"","formattedTitle":"ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears","fulltext":[{"header":"Administrative information ","content":"\u003cp\u003eThis protocol has been prepared according to the SPIRIT statement and the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"92%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eTitle\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{1}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eARC (Australian Rotator Cuff) trial: a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eTrial registration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{2a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eThe trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eTrial registration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{2b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eAll items from the World Health Organization Trial Registration Data Set are available in the registry (UTN U1111-1251-6599), and distributed within text of manuscript where applicable\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eProtocol version\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eThis publication is a summary of version 16 of the study protocol dated 15 July 2024\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eFunding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eThe study is funded by the Whitlam Orthopaedic Research Centre, a not-for-profit charitable gift recipient organization. The funding organisation has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eAuthor details\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eAll protocol contributors and affiliations are listed above, under \u0026ldquo;Names of protocol contributors\u0026rdquo; and \u0026ldquo;Institutions\u0026rdquo;.\u003c/p\u003e\n \u003cp\u003eIAH is the Principal Investigator and conceived the study and drafted the protocol. All authors contributed to the study protocol.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eName and contact information of the trial sponsor\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eResearch Grants and Contracts,\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDivision of Research and Enterprise\u003c/p\u003e\n \u003cp\u003eLevel 3, Rupert Myers Building (South Wing)\u003c/p\u003e\n \u003cp\u003eUNSW SYDNEY 2052, NSW, Australia\u003c/p\u003e\n \u003cp\u003eE: [email protected]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eRoles of sponsor\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 6px;\"\u003e\n \u003cp\u003e{5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eStudy sponsor has no role in or authority over study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication.\u003c/p\u003e\n \u003cp\u003eThe study is sponsored by UNSW Sydney. The sponsor has delegated to the Principal Investigator (IAH) the role of study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Introduction ","content":"\u003cp\u003e\u003cstrong\u003eBackground and rationale {6a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRotator cuff pathology is common and increases with age, affecting many people\u0026nbsp;over\u0026nbsp;the\u0026nbsp;age\u0026nbsp;of\u0026nbsp;45\u0026nbsp;years\u0026nbsp;and\u0026nbsp;most\u0026nbsp;people\u0026nbsp;over\u0026nbsp;the\u0026nbsp;age\u0026nbsp;of\u0026nbsp;60, with\u0026nbsp;more than half having shoulder pain.\u003csup\u003e1,2\u003c/sup\u003e Shoulder pain is common (22% prevalence in adults) and makes up approximately\u0026nbsp;1%\u0026nbsp;of\u0026nbsp;all\u0026nbsp;primary\u0026nbsp;care\u0026nbsp;presentations,\u0026nbsp;85%\u0026nbsp;of\u0026nbsp;which\u0026nbsp;will\u0026nbsp;have\u0026nbsp;rotator\u0026nbsp;cuff\u0026nbsp;pathology.\u003csup\u003e3-6\u003c/sup\u003e Large acute tears may occur as a result of significant trauma (such as a shoulder dislocation) but most tears are not acute.\u003c/p\u003e\n\u003cp\u003eThe two most common surgical procedures for patients with shoulder pain are subacromial decompression and rotator cuff repair (suturing and anchoring the torn tendon to the humeral head insertion), either separately or in combination.\u003c/p\u003e\n\u003cp\u003eSubacromial\u0026nbsp;decompression\u0026nbsp;is\u0026nbsp;performed\u0026nbsp;arthroscopically\u0026nbsp;and\u0026nbsp;involves\u0026nbsp;removal\u0026nbsp;of\u0026nbsp;bursal\u0026nbsp;tissue\u0026nbsp;and the bony under-surface of the acromion to decompress the passage of the rotator cuff tendons\u0026nbsp;through\u0026nbsp;the\u0026nbsp;subacromial\u0026nbsp;space.\u0026nbsp;The\u0026nbsp;effectiveness\u0026nbsp;of\u0026nbsp;subacromial\u0026nbsp;decompression as stand-alone treatment\u0026nbsp;for\u0026nbsp;rotator cuff\u0026nbsp;disease\u0026nbsp;(excluding full thickness tears) has been called into question based upon high-certainty evidence that it provides no clinically important benefits over placebo in pain or function\u003csup\u003e7-9\u003c/sup\u003e with a BMJ guideline panel making a strong recommendation against use of this surgery for shoulder pain.\u003csup\u003e10\u0026nbsp;\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe Australian Rotator Cuff (ARC) study investigates the effectiveness of a strategy to surgically repair full thickness, non-acute tears. Such\u0026nbsp;lesions\u0026nbsp;make\u0026nbsp;up over\u0026nbsp;75% of all\u0026nbsp;tears\u003csup\u003e11\u003c/sup\u003e and are\u0026nbsp;often treated with\u0026nbsp;surgery\u0026nbsp;following failed\u0026nbsp;non-operative management. Rotator cuff repair is the most common surgical procedure performed in the shoulder, with rates increasing.\u003csup\u003e12-17\u003c/sup\u003e The\u0026nbsp;rationale for\u0026nbsp;surgical repair\u0026nbsp;is\u0026nbsp;to\u0026nbsp;improve\u0026nbsp;symptoms\u0026nbsp;(pain\u0026nbsp;and\u0026nbsp;function)\u0026nbsp;which are\u0026nbsp;believed to\u0026nbsp;arise from\u0026nbsp;the\u0026nbsp;tear\u0026nbsp;and\u0026nbsp;to\u0026nbsp;prevent\u0026nbsp;the\u0026nbsp;tear\u0026nbsp;from\u0026nbsp;becoming\u0026nbsp;larger.\u003c/p\u003e\n\u003cp\u003eIn\u0026nbsp;contrast\u0026nbsp;to\u0026nbsp;subacromial\u0026nbsp;decompression,\u0026nbsp;results from a randomised placebo-controlled trial\u0026nbsp;of rotator cuff repair have not been reported. A 2019 Cochrane review from 2019 that included nine randomised trials involving 1007 participants comparing rotator cuff repair with or without decompression to other active interventions noted that all trials were at high risk of bias, most notably for selection and performance bias due to failure to blind both participants and study personnel to treatment allocation.\u003csup\u003e18\u003c/sup\u003e The review found low certainty evidence that rotator cuff repair provides little or no benefit in pain, function and quality of life compared to non-operative treatment and no added benefit over subacromial decompression alone. In addition, there are high rates of re-tears (following repair) at one to two years,\u003csup\u003e19-21\u003c/sup\u003e the structural integrity of the cuff after surgical repair does not correlate with clinically important differences in pain or function, and many tears do not progress if left unrepaired.\u003csup\u003e22-24\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eUncertainty\u0026nbsp;around\u0026nbsp;the\u0026nbsp;effectiveness\u0026nbsp;of\u0026nbsp;surgical\u0026nbsp;rotator\u0026nbsp;cuff\u0026nbsp;repair\u0026nbsp;is\u0026nbsp;also\u0026nbsp;reflected\u0026nbsp;in\u0026nbsp;variation\u0026nbsp;in\u0026nbsp;rates\u0026nbsp;of surgery and surgeon preference.\u003csup\u003e25,26\u003c/sup\u003e As a result of practice variation and evidence uncertainty, high quality trials for rotator cuff tears were listed in the top ten research priorities for shoulder surgery in a multidisciplinary priority setting exercise using the James Lind Alliance Priority Setting Partnership methods in 2016.\u003csup\u003e27\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives {7}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;ARC\u0026nbsp;trial\u0026nbsp;aims\u0026nbsp;to\u0026nbsp;determine\u0026nbsp;the\u0026nbsp;effectiveness,\u0026nbsp;safety\u0026nbsp;and\u0026nbsp;cost-effectiveness of arthroscopic shoulder surgery with rotator cuff repair compared with arthroscopic shoulder\u0026nbsp;surgery without rotator cuff repair, for improving shoulder\u0026nbsp;pain\u0026nbsp;and\u0026nbsp;function,\u0026nbsp;and\u0026nbsp;quality\u0026nbsp;of life in people with symptoms attributed to non-acute, full thickness rotator cuff tears. The study hypothesis is that in people\u0026nbsp;aged\u0026nbsp;45\u0026nbsp;to\u0026nbsp;75\u0026nbsp;years\u0026nbsp;with\u0026nbsp;at\u0026nbsp;least\u0026nbsp;6 months\u0026nbsp;of\u0026nbsp;shoulder\u0026nbsp;symptoms\u0026nbsp;and\u0026nbsp;a\u0026nbsp;complete,\u0026nbsp;surgically reparable rotator cuff tear, arthroscopic surgery with repair of the tear is superior to arthroscopic surgery without repair in improving shoulder pain and function at 6 months post-surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial design {8}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe ARC trial is a multicentre, two-parallel group, blinded, randomised, placebo-controlled superiority trial. All eligible patients at participating sites will be approached to participate. Those who consent will undergo shoulder arthroscopy to confirm eligibility (size and location of rotator cuff tear) and address other pathology (e.g. acromial pathology, see below), and then randomised intra-operatively by online randomisation service to either arthroscopic surgical rotator cuff repair or no repair in a 1:1 ratio. Concomitant arthroscopic procedures (see \u0026ldquo;Interventions\u0026rdquo;, below) will be performed as per current usual practice and prior to\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003erandomisation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePatient involvement\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was discussed in a focus group of rotator cuff surgery patients. The consumers understood the need for the trial and were comfortable with the use of placebo surgery. Furthermore, they were comfortable with the use of a common rehabilitation protocol, follow up\u0026nbsp;by\u0026nbsp;a\u0026nbsp;surgeon\u0026nbsp;not\u0026nbsp;involved\u0026nbsp;in\u0026nbsp;their\u0026nbsp;operation,\u0026nbsp;and\u0026nbsp;maintenance\u0026nbsp;of\u0026nbsp;blinding.\u0026nbsp;They\u0026nbsp;considered it important to have no costs to the participants (as planned) and felt that the closer follow up associated\u0026nbsp;with\u0026nbsp;trial\u0026nbsp;participation,\u0026nbsp;the\u0026nbsp;avoidance\u0026nbsp;of\u0026nbsp;any\u0026nbsp;costs,\u0026nbsp;and\u0026nbsp;contributing\u0026nbsp;to\u0026nbsp;the\u0026nbsp;evidence that will assist with the management of future patients were strong drivers to participate.\u003c/p\u003e\n\u003cp\u003eThe trial protocol has also been reviewed by the Consumer Advisory and Scientific Committees of the Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network and feedback has been incorporated. The ANZMUSC Executive Committee has endorsed the trial. The study includes two people with shoulder pain as investigators.\u003c/p\u003e"},{"header":"Methods: participants, interventions and outcomes","content":"\u003cp\u003e\u003cstrong\u003eStudy setting {9}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;study\u0026nbsp;setting\u0026nbsp;will\u0026nbsp;parallel\u0026nbsp;usual\u0026nbsp;practice.\u0026nbsp;Operating surgeons will be specialist shoulder surgeons. The\u0026nbsp;consultations\u0026nbsp;and\u0026nbsp;surgery will\u0026nbsp;be\u0026nbsp;performed\u0026nbsp;in\u0026nbsp;healthcare sites\u0026nbsp;(public and/or private)\u0026nbsp;normally\u0026nbsp;used\u0026nbsp;by\u0026nbsp;the\u0026nbsp;study\u0026nbsp;surgeons,\u0026nbsp;including all\u0026nbsp;usual\u0026nbsp;personnel\u0026nbsp;(physiotherapists,\u0026nbsp;nurses, trainee surgeons, anaesthetists etc.).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria {10}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInclusion Criteria\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eAge\u0026nbsp;45\u0026nbsp;\u0026ndash;\u0026nbsp;75\u0026nbsp;years\u0026nbsp;inclusive\u0026nbsp;(older\u0026nbsp;patients\u0026nbsp;are\u0026nbsp;usually\u0026nbsp;treated\u0026nbsp;non-operatively\u0026nbsp;and\u0026nbsp;younger patients are less likely to have non-acute tears)\u003c/li\u003e\n \u003cli\u003eAt\u0026nbsp;least\u0026nbsp;6\u0026nbsp;months\u0026nbsp;duration\u0026nbsp;of\u0026nbsp;shoulder\u0026nbsp;symptoms\u003c/li\u003e\n \u003cli\u003eComplete\u0026nbsp;tear\u0026nbsp;of\u0026nbsp;supraspinatus\u0026nbsp;tendon\u0026nbsp;on\u0026nbsp;Magnetic\u0026nbsp;Resonance\u0026nbsp;Imaging\u0026nbsp;(MRI)\u003c/li\u003e\n \u003cli\u003eRotator cuff repair is considered the primary reason for surgery\u003c/li\u003e\n \u003cli\u003eEnglish\u0026nbsp;speaking\u003c/li\u003e\n \u003cli\u003eAvailable\u0026nbsp;for\u0026nbsp;post-operative\u0026nbsp;rehabilitation\u0026nbsp;and\u0026nbsp;follow\u0026nbsp;up\u0026nbsp;for\u0026nbsp;at\u0026nbsp;least\u0026nbsp;6\u0026nbsp;months\u003c/li\u003e\n \u003cli\u003eComplete tear of the supraspinatus tendon\u0026nbsp;confirmed\u0026nbsp;at arthroscopy as being 1 to 4cm in anteroposterior length with or without extension into infraspinatus and allowing tearing of the superior 1/3 of subscapularis tendons and considered arthroscopically reparable\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eExclusion Criteria\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePregnancy\u003c/li\u003e\n \u003cli\u003eTear\u0026nbsp;extending\u0026nbsp;beyond\u0026nbsp;superior\u0026nbsp;1/3\u0026nbsp;of\u0026nbsp;subscapularis\u0026nbsp;tendon\u003c/li\u003e\n \u003cli\u003ePrior rotator cuff\u0026nbsp;surgery\u0026nbsp;of the\u0026nbsp;affected\u0026nbsp;shoulder\u003c/li\u003e\n \u003cli\u003eStage\u0026nbsp;3\u0026nbsp;or\u0026nbsp;higher\u0026nbsp;fatty\u0026nbsp;atrophy\u0026nbsp;of\u0026nbsp;the rotator cuff muscles\u0026nbsp;and\u0026nbsp;a\u0026nbsp;positive\u0026nbsp;Tangent\u0026nbsp;sign\u0026nbsp;(relative contraindication to repair due to low success rate)\u003csup\u003e28\u003c/sup\u003e\u003c/li\u003e\n \u003cli\u003eGlenohumeral\u0026nbsp;osteoarthritis\u0026nbsp;(Outerbridge\u0026nbsp;Grade\u0026nbsp;III\u0026nbsp;or\u0026nbsp;higher\u0026nbsp;measured\u0026nbsp;during\u0026nbsp;arthroscopy)\u003csup\u003e29\u003c/sup\u003e or loss of joint space or osteophyte on pre-operative imaging\u003c/li\u003e\n \u003cli\u003eFrozen\u0026nbsp;shoulder\u0026nbsp;(\u0026gt;50%\u0026nbsp;loss\u0026nbsp;global\u0026nbsp;passive\u0026nbsp;range) and/or\u0026nbsp;proposed\u0026nbsp;capsular\u0026nbsp;release\u003c/li\u003e\n \u003cli\u003eA\u0026nbsp;traumatic\u0026nbsp;tear\u0026nbsp;(an acute event that is more than\u0026nbsp;a\u0026nbsp;fall\u0026nbsp;from\u0026nbsp;standing\u0026nbsp;height)\u0026nbsp;that\u0026nbsp;has\u0026nbsp;occurred within\u0026nbsp;the\u0026nbsp;last\u0026nbsp;six\u0026nbsp;months\u003c/li\u003e\n \u003cli\u003eCurrent\u0026nbsp;use\u0026nbsp;of\u0026nbsp;oral\u0026nbsp;glucocorticoids,\u0026nbsp;immunosuppressants; there will be no exclusion based on prior therapies\u003c/li\u003e\n \u003cli\u003eRheumatoid\u0026nbsp;arthritis\u0026nbsp;or\u0026nbsp;other\u0026nbsp;autoimmune\u0026nbsp;inflammatory\u0026nbsp;arthropathy\u003c/li\u003e\n \u003cli\u003eShoulder\u0026nbsp;instability\u0026nbsp;(history\u0026nbsp;of\u0026nbsp;dislocation)\u003c/li\u003e\n \u003cli\u003eOsteonecrosis\u0026nbsp;of\u0026nbsp;the\u0026nbsp;humeral\u0026nbsp;head\u003c/li\u003e\n \u003cli\u003eResident\u0026nbsp;of\u0026nbsp;a\u0026nbsp;residential\u0026nbsp;aged\u0026nbsp;care facility\u003c/li\u003e\n \u003cli\u003eShoulder\u0026nbsp;condition\u0026nbsp;covered\u0026nbsp;by\u0026nbsp;workers\u0026rsquo;\u0026nbsp;compensation\u0026nbsp;insurance\u0026nbsp;(this\u0026nbsp;is\u0026nbsp;associated\u0026nbsp;with\u0026nbsp;poor results and may bias against any effectiveness of surgery\u003csup\u003e30\u003c/sup\u003e)\u003c/li\u003e\n \u003cli\u003eLimited\u0026nbsp;English\u0026nbsp;proficiency\u0026nbsp;or\u0026nbsp;cognitive\u0026nbsp;impairment\u0026nbsp;precluding\u0026nbsp;fully\u0026nbsp;informed\u0026nbsp;consent\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWho will take informed consent {26a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePotential\u0026nbsp;participants\u0026nbsp;will\u0026nbsp;be\u0026nbsp;identified\u0026nbsp;from\u0026nbsp;the\u0026nbsp;participating sites\u0026nbsp;(private\u0026nbsp;and\u0026nbsp;public settings)\u0026nbsp;where study surgeons work. If\u0026nbsp;the\u0026nbsp;surgeon considers rotator cuff repair surgery to be indicated and the cuff repair to be the main reason for surgery,\u0026nbsp;patients\u0026nbsp;will\u0026nbsp;be approached to\u0026nbsp;participate,\u0026nbsp;informed of\u0026nbsp;the trial, given written information and contacted by the research team prior to deciding whether to participate. Consent will be collect using an online consent form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo additional consent procedures will be used and no specimens will be taken as part of the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExplanation for the choice of comparators {6b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBy comparing arthroscopic surgery with rotator cuff repair to arthroscopic surgery without rotator cuff repair, the only difference between study groups will be the presence or absence of the active component of the intervention being tested (i.e., rotator cuff repair). Isolating the active ingredient of the procedure being studied allows the study to provide the least biased estimate of efficacy of rotator cuff repair in the study population.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention description {11a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe active intervention is arthroscopic shoulder surgery with rotator cuff repair. The surgical technique will be according to surgeon preference. The type of repair (e.g., double row versus single row) will be recorded. Surgery will be performed within 90 days of consent where possible, and baseline data will be collected within 42 days of surgery in all cases.\u003c/p\u003e\n\u003cp\u003eThe control intervention (placebo) is arthroscopic shoulder surgery without rotator cuff repair. In both groups, concomitant procedures will be allowed prior to intra-operative randomisation.\u003c/p\u003e\n\u003cp\u003eFor both groups, anaesthesia and surgical set-up will be according to local standard practice. Arthroscopy will use standard portals with full visualisation to allow diagnostic arthroscopy. Exposure of the rotator cuff tear\u0026nbsp;will\u0026nbsp;be\u0026nbsp;sufficient to allow\u0026nbsp;visualisation, measurement and recording (site,\u0026nbsp;size\u0026nbsp;and\u0026nbsp;reparability)\u0026nbsp;of\u0026nbsp;the\u0026nbsp;tear to confirm eligibility, and subsequent repair if randomised to that arm of the trial. At the conclusion of the procedure, the arm will be\u0026nbsp;placed in a shoulder immobiliser\u0026nbsp;sling in both groups. Intra-operative images will be taken as per usual practice and will be used for inclusion criteria and treatment verification.\u003c/p\u003e\n\u003cp\u003eAllowing\u0026nbsp;concomitant procedures\u0026nbsp;more closely resembles usual\u0026nbsp;practice,\u0026nbsp;making\u0026nbsp;the study more pragmatic and generalisable. It also increases acceptability\u003cem\u003e\u0026nbsp;\u003c/em\u003eby participants and surgeons. Further, by retaining all elements of the procedure with the exception of the active ingredient of the study intervention\u003cem\u003e\u0026nbsp;\u003c/em\u003e(rotator cuff repair), the requirements for high-fidelity placebo surgery are met.\u003csup\u003e31\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe permitted concomitant procedures will be bursal debridement, acromioplasty, biceps tendon tenodesis\u0026nbsp;or\u0026nbsp;tenotomy, and acromioclavicular joint resection.\u0026nbsp;Concomitant procedures will be performed prior to randomisation and will not require any change to the post-operative rehabilitation\u003cem\u003e.\u0026nbsp;\u003c/em\u003eConcomitant procedures will be balanced between groups (through randomisation alone or the minimisation algorithm used in the randomisation process).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePost-operative analgesia (including nerve\u0026nbsp;blocks)\u0026nbsp;will\u0026nbsp;be\u0026nbsp;as\u0026nbsp;per\u0026nbsp;usual\u0026nbsp;care\u0026nbsp;for\u0026nbsp;each\u0026nbsp;treating\u0026nbsp;surgeon. Whilst the focus of this trial is the surgery, participants and their physiotherapists will receive written guidance on good quality post-operative rehabilitation\u0026nbsp;which includes a\u0026nbsp;graded\u0026nbsp;program\u0026nbsp;divided into phases, informed by recommendations from the recent consensus statement of the American Society of Shoulder and Elbow Therapists\u003csup\u003e32\u003c/sup\u003e and the protocol of the current ACCURATE placebo RCT.\u003csup\u003e33\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003ePhysiotherapists\u0026nbsp;will\u0026nbsp;be\u0026nbsp;guided\u0026nbsp;to\u0026nbsp;follow\u0026nbsp;four phases\u0026nbsp;of\u0026nbsp;rehabilitation\u0026nbsp;that\u0026nbsp;represent\u0026nbsp;a\u0026nbsp;consensus of current best practice recommendations:\u003c/p\u003e\n\u003cul style=\"list-style-type: circle;\"\u003e\n \u003cli\u003ePhase 1 (0-4 weeks): arm placed in sling, passive and assisted range of motion (ROM).\u003c/li\u003e\n \u003cli\u003ePhase\u0026nbsp;2\u0026nbsp;(5-8\u0026nbsp;weeks):\u0026nbsp;active-assisted\u0026nbsp;ROM\u0026nbsp;unloading\u0026nbsp;rotator\u0026nbsp;cuff.\u003c/li\u003e\n \u003cli\u003ePhase\u0026nbsp;3\u0026nbsp;(9-12\u0026nbsp;weeks):\u0026nbsp;active-unloaded\u0026nbsp;exercises,\u0026nbsp;isometric\u0026nbsp;cuff\u0026nbsp;strengthening.\u003c/li\u003e\n \u003cli\u003ePhase\u0026nbsp;4\u0026nbsp;(13-20\u0026nbsp;weeks):\u0026nbsp;active\u0026nbsp;ROM,\u0026nbsp;dynamic\u0026nbsp;strengthening\u0026nbsp;exercises\u0026nbsp;for\u0026nbsp;cuff\u0026nbsp;and\u0026nbsp;scapula.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003ePhysiotherapists will be guided to progress\u0026nbsp;to\u0026nbsp;each\u0026nbsp;phase\u0026nbsp;dependent\u0026nbsp;on\u0026nbsp;time\u0026nbsp;and\u0026nbsp;milestone\u0026nbsp;achievement.\u003c/p\u003e\n\u003cp\u003eParticipants will be followed-up directly (electronically or by telephone/ mail) for study data collection at 1-2 weeks, 6-8 weeks, 3 months, 6, 12 month and 24 months. Five and ten year follow up will be subject to additional funding. Participants will be followed in person by a blinded surgeon other than their operating surgeon at 1-2 weeks, 6-8 weeks, 3 months and 6 months. If further surgical reviews are required beyond 6 months, this will be dependent on the participant\u0026rsquo;s post-surgical progress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCriteria for discontinuing or modifying allocated interventions\u003c/strong\u003e \u003cstrong\u003e{11b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe interventions are one-off procedures and cannot be discontinued or modified after being provided. Surgeons are allowed to modify the technique of rotator cuff repair according to usual preference.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrategies to improve adherence to interventions {11c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipant adherence to the interventions is not applicable as the intervention is applied during their surgical procedure, under anaesthetic. Surgeon adherence will be monitored by inspection of intra-operative imaging. Participant adherence to the post-operative physiotherapy program will be monitored by surveying all participants regarding attendance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConcomitant surgical procedures are listed above, under \u0026ldquo;Intervention description\u0026rdquo; and these will be performed prior to randomisation. All participants (in both groups) will undergo routine care associated with rotator cuff repair surgery, including anaesthesia, post-operative pain relief and post-operative rehabilitation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvisions for post-trial care {30}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will be managed by the post-operative surgeon and physiotherapists according to usual care, including the management of any complications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes {12}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBaseline data (Table 1) will be collected up to 6 weeks prior to surgery. Surgical data (Table 2) will be collected at the time of surgery.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe primary outcome is the Western Ontario Rotator Cuff Index (WORC) measured at 6 months post-surgery. The WORC is a self-administered condition-specific health questionnaire specifically designed for rotator cuff disease and its treatment.\u003csup\u003e34\u003c/sup\u003e It consists of 21 questions encompassing 5 domains: symptoms, sport and recreation, work, social function and emotions and can be presented in a summary score on a scale from zero (no symptoms or limitations) to 2100 (each question is scored on a 0-100 scale). The raw score will be converted to the final WORC, which ranges from 0 to 100, with higher scores indicating worse pain and function. The final WORC score is calculated by subtracting the raw WORC score from 2100 and dividing the result by 21 to create a score out of 100. The WORC was chosen because it is widely used for studies of rotator cuff repair, has been validated in that population, has better internal consistency, reliability, content validity and responsiveness than other shoulder outcome tools,\u003csup\u003e35\u003c/sup\u003e has no floor or ceiling effect,\u003csup\u003e36\u003c/sup\u003e and is the primary outcome in the current (ACCURATE) placebo rotator cuff repair trial (thereby enabling direct comparison).\u003csup\u003e33\u003c/sup\u003e WORC was recommended by the surgeon investigators and was developed with direct patient input.\u003csup\u003e34\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eSecondary outcomes are:\u003c/p\u003e\n\u003cul class=\"decimal_type\"\u003e\n \u003cli\u003e\u003cu\u003eHealth-related quality of life:\u0026nbsp;\u003c/u\u003eEuroQoL 5 Domain (EQ5D-5L) \u0026amp; EuroQoL Visual Analogue Scale (EQ-VAS),\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003ea validated generic quality of life questionnaire. Comprises of five questions on mobility, self-care, pain, usual activities, and psychological status with five possible answers for each item and a VAS to indicate general health status.\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eShoulder patient global perceived effect:\u003c/u\u003e a 5-point Likert Scale measuring \u003cem\u003e\u0026ldquo;How is your shoulder now compared to before the surgery?\u0026rdquo;\u003c/em\u003e:\u003cem\u003e\u0026nbsp;\u003c/em\u003emuch worse, a little worse, about the same, a little better, much better.\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eShoulder pain at rest:\u003c/u\u003e a Numerical Rating Scale from 0 to 10 with \u0026lsquo;0\u0026rsquo; representing no pain and \u0026lsquo;10\u0026rsquo; representing the worst pain imaginable\u003cem\u003e\u0026nbsp;\u003c/em\u003ein the preceding week.\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eShoulder pain with activity:\u003c/u\u003e a Numerical Rating Scale from 0 to 10 with \u0026lsquo;0\u0026rsquo; representing no pain and \u0026lsquo;10\u0026rsquo; representing the worst pain imaginable\u003cem\u003e\u0026nbsp;\u003c/em\u003ein the preceding week.\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eWork\u0026nbsp;status\u003c/u\u003e: normal duties, restricted duties/hours, not working.\u003c/li\u003e\n \u003cli\u003e\u003cu\u003ePost-operative\u0026nbsp;physiotherapy\u0026nbsp;attendance\u0026nbsp;at\u0026nbsp;6\u0026nbsp;months\u003c/u\u003e: 0-4 sessions, 5-9 sessions, equal to or greater than 10 sessions.\u003c/li\u003e\n \u003cli\u003e\u003cu\u003ePresence and size of complete rotator cuff tear on MRI at 12 months:\u003c/u\u003e measured in centimetres to one decimal place\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eAcromio-humeral distance on MRI at 12 months:\u003c/u\u003e measured in millimetres\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eOsteoarthritis on MRI at 12 months:\u003c/u\u003e according to modified Samsilon \u0026amp; Prieto Score.\u003csup\u003e37\u003c/sup\u003e\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eMuscle wasting of rotator cuff on MRI at 12 months:\u003c/u\u003e measured using Goutallier classification (Stage 0 \u0026ndash; 4).\u003csup\u003e28\u003c/sup\u003e\u003c/li\u003e\n \u003cli\u003e\u003cu\u003eComplications:\u003c/u\u003e death, frozen shoulder, infection requiring treatment, repeat surgery.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe\u0026nbsp;outcomes\u0026nbsp;include\u0026nbsp;the\u0026nbsp;four\u0026nbsp;mandatory\u0026nbsp;clinical\u0026nbsp;trial\u0026nbsp;domains\u0026nbsp;(pain,\u0026nbsp;function,\u0026nbsp;patient global assessment of the shoulder, and adverse events including death) and the majority of the four \u0026lsquo;important but optional\u0026rsquo; domains (participation (recreation/work), sleep, emotional wellbeing and condition- specific pathophysiological manifestations) in the OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders.\u003csup\u003e38\u0026nbsp;\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eTable 1. Baseline variables\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariable\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eUnit of measurement\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eAge at time of consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eYears\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eSex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eMale, female\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eHand dominance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eLeft, right\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eEducational attainment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eNo schooling, primary, high school, vocational training, bachelor, masters, doctorate, other\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eMedical history\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eHigh blood pressure, diabetes, osteoporosis, neck pain, heart condition, stomach disorder, bowel or intestinal disorder, depression anxiety, chronic respiratory illness, kidney disease\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eCurrent medications\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eYes, no\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eWORC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003e0-100, higher scores representing better pain and function\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eEQ-5D-5L\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eNumeric\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eEQ-VAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eNumeric\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eShoulder pain at rest\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eNumeric rating scale 0-10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eShoulder pain with activity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eNumeric rating scale 0-10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eHeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eCentimetres\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eKilograms\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eCurrent smoker\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eYes, no\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eDuration of symptoms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003e6-12 months, more than 12 months\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eWork status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eNormal duties, restricted duties/hours, not working\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eStrength tests (Geelong sites)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eShoulder abduction \u0026amp; external rotation power (Newtons)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 237px;\"\u003e\n \u003cp\u003eSize of complete tear on MRI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 405px;\"\u003e\n \u003cp\u003eCentimetres to one decimal place (mm) in antero-posterior plane\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2. Surgical variables\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariable\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eUnits of measurement\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eASA grade\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eI, II, II, IV\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eDate of surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eDate\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eLength of tear\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eCentimetres to one decimal place (mm) in antero-posterior (length) and medial-lateral (width) planes\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eInvolvement of infraspinatus\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eYes, no\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eBiceps condition\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eNormal, tendinosis, subluxation, ruptured\u0026nbsp;(choose\u0026nbsp;highest applicable)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eBiceps surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eNone, tenotomy, tenodesis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eBiceps fixation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eNone, screw, button\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eGlenoid osteoarthritis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eOuterbridge grade 0, 1, 2, 3, 4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eHumeral osteoarthritis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eOuterbridge grade 0, 1, 2, 3, 4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 245px;\"\u003e\n \u003cp\u003eCuff repair\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 346px;\"\u003e\n \u003cp\u003eNo repair, repair (single vs double row, number of anchors)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant timeline {13}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 3 provides the schedule of participant contact.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable\u0026nbsp;3.\u0026nbsp;Schedule\u0026nbsp;of\u0026nbsp;study\u0026nbsp;procedures\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"727\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eEnrolment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eVisit 1 -Surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003ePS-1\u003c/p\u003e\n \u003cp\u003e1-2\u003cbr\u003eweeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003ePS-2\u003c/p\u003e\n \u003cp\u003e6-8\u003cbr\u003eweeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003ePS-3\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3\u003cbr\u003emonths\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003ePS-4\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e6\u003cbr\u003emonths\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003ePS-5\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e12\u003cbr\u003emonths\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003ePS-6\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e24\u0026nbsp;months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003ePS-7\u003c/p\u003e\n \u003cp\u003e5 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003ePS-8\u003c/p\u003e\n \u003cp\u003e10 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eInformed Consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eInclusion\u0026nbsp;/\u0026nbsp;Exclusion criteria\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eCopy\u0026nbsp;of\u0026nbsp;clinical MRI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003csup\u003e#\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eMedical\u0026nbsp;history/demographics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eSurgery / randomisation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eOperation reports\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eSurgeon\u0026nbsp;follow up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eBlinding fidelity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eShoulder strength\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eWork status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003ePhysiotherapy\u0026nbsp;attendance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eOutcome questionnaires\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003eAE/ SAE\u003c/p\u003e\n \u003cp\u003e/Complications\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 52px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 56px;\"\u003e\n \u003cp\u003eX*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eX*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePS\u0026nbsp;\u0026ndash;\u0026nbsp;Post\u0026nbsp;Surgery\u003cbr\u003e\u0026nbsp;# 11-18 months\u003cbr\u003e\u0026nbsp;* only Complications will be recorded (not adverse events)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size {14}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size used during initial trial registration was based on detecting a 0.5 standard deviation (SD) difference between groups. Recent research has reported the Smallest Worthwhile Effect (SWE) for the ARC study, specifically comparing the two groups used in this trial.\u003csup\u003e39\u003c/sup\u003e The median SWE for improvement in pain and function within six months for rotator cuff repair surgery over subacromial decompression alone was 40% and the lower limit of the interquartile range was 20%. We chose to power the study based on the lower estimate of 20% improvement in the raw WORC score, which converts to 14% change in the final (0-100) WORC based on baseline values in this population (both the SWE study and the ARC study to date). The minimum important difference in the WORC has been reported at similar levels of 13 and 14 points.\u003csup\u003e40-42\u003c/sup\u003e The SD of the WORC post-rotator cuff tear has been estimated at 17-20.\u003csup\u003e43-45\u003c/sup\u003e Using a 14 point between-group difference in the WORC at 90% power and a p value of 0.05 and assuming a conservative estimate of 20 for the SD, 86 participants are required (43 in each group). Therefore, we aim to recruit until we have primary outcome (6 months) data for 86 participants excluding crossovers up to 6 months.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment {15}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt least 8 centres will be included to ensure achievement of the sample size. Surgeons will be asked to complete screening logs and complete screening forms for potential participants. Monthly newsletters will be provided to investigators and these will include recruitment rates and targets.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: allocation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSequence generation {16a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRandomisation will occur by use of the computer-generated interactive web response system of the Griffith University Randomisation Service. Randomisation will be 1:1 between groups and will use the technique of minimisation to balance groups for age, surgeon and concomitant procedures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConcealment mechanism {16b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUse of the online interactive web response system will ensure concealment of the allocation until it is assigned.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation {16c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe allocation sequence will be computer-generated and allocated by the interactive web response system. The system will be accessed by the operating surgeon or their delegate intra-operatively. The intervention will be assigned by the operating surgeon.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho will be blinded {17a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOperating surgeons will not be blinded. Participants, the post-surgical care team, including follow-up surgeons, rehabilitation physiotherapists\u0026nbsp;and\u0026nbsp;the\u0026nbsp;study management\u0026nbsp;team\u0026nbsp;will\u0026nbsp;remain\u0026nbsp;blinded\u0026nbsp;for\u0026nbsp;the\u0026nbsp;duration\u0026nbsp;of\u0026nbsp;the\u0026nbsp;study. Participants\u0026nbsp;will\u0026nbsp;be\u0026nbsp;followed\u0026nbsp;up\u0026nbsp;by\u0026nbsp;a\u0026nbsp;different\u0026nbsp;surgeon\u0026nbsp;to the operating surgeon (a\u0026nbsp;blinded\u0026nbsp;trial\u0026nbsp;surgeon\u0026nbsp;at\u0026nbsp;the\u0026nbsp;same\u0026nbsp;site).\u003c/p\u003e\n\u003cp\u003eMaintenance of blinding will be supported by information provided in patient study cards (to be carried with participants and presented to treating practitioners), and letters provided to treating general practitioners and physiotherapists informing them of the trial procedures.\u003c/p\u003e\n\u003cp\u003eOperation reports will be standardised as \u0026ldquo;Treatment according to the ARC study protocol\u0026rdquo;. An unblinded operation report (standard report) will be produced and kept by the treating surgeon and only released if unblinding is deemed necessary (e.g. further surgery required).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBlinding fidelity will be tested during follow-up (see Table 3 for timing) by asking each participant which group they believe they are in: rotator cuff repair, no rotator cuff repair, or unsure.\u003c/p\u003e\n\u003cp\u003eThe statisticians responsible for the analyses will program all the analyses indicated in the statistical analysis plan using a masked treatment allocation performed by an independent statistician.\u0026nbsp;The\u0026nbsp;statisticians\u0026nbsp;will\u0026nbsp;provide\u0026nbsp;the\u0026nbsp;Writing\u0026nbsp;Committee\u0026nbsp;with\u0026nbsp;blinded\u0026nbsp;results\u0026nbsp;from\u0026nbsp;the analyses, with the two arms labelled A and B. The Writing Committee will then meet to consider the interpretations of the results until a consensus is reached for each alternative interpretation (based on the two possible treatment allocations), prior to unblinding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProcedure for unblinding if needed {17b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIf\u0026nbsp;the\u0026nbsp;participant\u0026rsquo;s treating\u0026nbsp;clinicians at\u0026nbsp;any time\u0026nbsp;during\u0026nbsp;the\u0026nbsp;study\u0026nbsp;period deems a change in treatment is needed and unblinding may be necessary, the Trial Management Committee will decide if the patient will be unblinded. Participants will be encouraged to remain blinded for the first two years, after which time those who wish to know their treatment allocation will be unblinded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for assessment and collection of outcomes {18a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData will be collected directly in a REDCap\u003csup\u003e46,47\u003c/sup\u003e database. Participants will be directed to the REDCap interface for consent and entering survey responses. Surgical data will be entered into REDCap by the research team based on case report forms completed intra-operatively by the surgeons.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe use of electronic links to online surveys is expected to improve participant follow-up. Participants who do not respond to electronic (email and text) reminders will be contacted by telephone but directed to enter the data directly where possible. Follow-up will continue regardless of protocol adherence.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management {19}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe REDCap database is provided, hosted and backed up regularly by the University of New South Wales, on a secure network. Data will be password protected and with separate access,\u0026nbsp;depending\u0026nbsp;on\u0026nbsp;the\u0026nbsp;study\u0026nbsp;role,\u0026nbsp;with\u0026nbsp;no\u0026nbsp;one\u0026nbsp;able\u0026nbsp;to\u0026nbsp;access\u0026nbsp;the\u0026nbsp;random\u0026nbsp;treatment\u0026nbsp;allocation except the unblinded statistician responsible for providing reports to the independent DSMC and an assigned unblinded study team member. Data access will be restricted to the TMG that will oversee day-to-day trial management. The SC will oversee study progress, data collection and integrity and will approve the statistical analysis plan and research protocol.\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;integrity of\u0026nbsp;trial data\u0026nbsp;will be\u0026nbsp;monitored by\u0026nbsp;regular\u0026nbsp;(monthly)\u0026nbsp;review\u0026nbsp;of data\u0026nbsp;for\u0026nbsp;omissions and errors. The database will be constructed with restricted ranges to reduce errors in data entry.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfidentiality {27}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePersonal information in the database will be password protected on a secure network. No identifying information will be used in any analysis, report or publication.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBiological specimens will not be collected in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will be reported according to the CONSORT statement and will include a CONSORT flowchart.\u003csup\u003e48\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eBaseline data will be described for each group separately and the total cohort. Baseline differences between groups will not be formally tested. The primary outcome (difference in WORC between groups at 6 months) will be analysed on an intention to treat basis using multivariable regression, adjusted for baseline WORC. The effect of the intervention will be estimated as the adjusted mean difference and its 95% confidence interval. The p value for the primary analysis will be reported based on the null hypothesis of no difference in shoulder pain and function at 6 months post-surgery between the two groups.\u003c/p\u003e\n\u003cp\u003eOther outcomes and timepoints for the primary outcome will be reported using regression adjusted for baseline scores where applicable. Dichotomous outcomes (e.g. complications) will be reported using logistic regression with no adjustments.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA secondary analysis including all WORC measurements will be conducted using a repeated-measures\u0026nbsp;linear\u0026nbsp;mixed\u0026nbsp;model\u0026nbsp;including\u0026nbsp;the\u0026nbsp;treatment\u0026nbsp;allocation,\u0026nbsp;the\u0026nbsp;visit\u0026nbsp;(timepoint), the\u0026nbsp;treatment-by-visit\u0026nbsp;interaction,\u0026nbsp;and\u0026nbsp;baseline\u0026nbsp;WORC.\u0026nbsp;A\u0026nbsp;random\u0026nbsp;subject\u0026nbsp;effect\u0026nbsp;or\u0026nbsp;a\u0026nbsp;repeated\u0026nbsp;effect\u0026nbsp;will\u0026nbsp;be\u0026nbsp;included\u0026nbsp;to\u0026nbsp;model\u0026nbsp;within-subject correlations. A detailed Statistical Analysis Plan will be developed and published prior to unblinding and database lock.\u003c/p\u003e\n\u003cp\u003eEligible patients who decline inclusion in the randomised trial will be invited to participate in a parallel observational study. Those treated surgically will be treated as per the intervention arm of the randomised trial. The\u0026nbsp;non-operative\u0026nbsp;group will be treated as per\u0026nbsp;usual care. The\u0026nbsp;observational cohort will be followed as per the randomised study (time points and outcomes) with the following differences:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eBaseline assessments must be completed within six weeks of enrolment, rather than within six weeks of the scheduled surgery.\u003c/li\u003e\n \u003cli\u003eAdverse events will not be collected as participants will not be assigned any study intervention and will be provided with unblinded \u0026lsquo;usual care\u0026rsquo;. Pre-determined complication outcomes as specified in Secondary Outcomes will still be obtained.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eData from this observational cohort will provide information on the generalisability of the results of the randomised trial and allow comparison between the control group and matched non-operative care.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterim analyses {21b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUnless\u0026nbsp;requested\u0026nbsp;by\u0026nbsp;the\u0026nbsp;DSMC,\u0026nbsp;no\u0026nbsp;interim\u0026nbsp;analysis\u0026nbsp;is planned.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eExploratory analyses will be performed to analyse the effect of tear size, concomitant procedures, surgeon and repair type on the primary outcome (interaction).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs randomisation occurs intra-operatively and the primary outcome is at 6 months, no crossovers and minimal loss to follow up are expected. A per-protocol analysis and imputation for missing data will only be performed if crossovers or loss to follow-up at six months (primary end-point) are greater than 5%.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol will be published and the full protocol made available on request. De-identified\u0026nbsp;study\u0026nbsp;data\u0026nbsp;and the statistical code\u0026nbsp;will\u0026nbsp;be\u0026nbsp;made\u0026nbsp;available\u0026nbsp;upon reasonable request,\u0026nbsp;after\u0026nbsp;publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Steering Committee oversees overall study design and conduct and comprises all investigators based in Australia. The Steering Committee will meet at least every 6 months. The coordinating centre at the Whitlam Orthopaedic Research Centre, supported by the Ingham Institute for Applied Medical Research and the University of New South Wales, oversees the trial\u0026rsquo;s overall management, including protocol adherence, site coordination, ethics, and data management. It provides organisational support and facilitates communication between trial sites and oversight committees. The central trial coordinator supports the trial\u0026rsquo;s daily operations.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Trial Management Group (TMG) oversees day-to-day trial management and consists of 5 of the study\u0026rsquo;s investigators, including the Coordinating Principal Investigator (CPI) the study\u0026rsquo;s two second co-investigators and the central trial coordinator. The TMG initially met monthly during trial set-up, and will meet every second month during recruitment and until trial close-out. The TMG review trial conduct, focusing on recruitment progress, data management, protocol adherence, safety reporting, and site performance. Any protocol or site-specific issues identified will be addressed through corrective actions to ensure compliance and trial integrity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Data Safety and Monitoring Committee (DSMC) oversees data management and safety and comprises a statistician, a shoulder surgeon and a rheumatologist. The DSMC will provide medical oversight and expertise concerning recommendations for the continuation, modification, or termination of the trial. The DSMC will be independent of the study sponsor, will not be involved in the study, will declare any competing interests and will not benefit in any way from the results of this trial. The DSMC will monitor AEs and SAEs to ensure the safety of participants. The DSMC will meet annually or as required to provide study oversight. The DSMC charter is available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event reporting and harms {22}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdverse events (AE) (non-serious AEs / Serious Adverse Events (SAE)/ Unexpected Related Serious Adverse Events), Significant Safety Issues and Urgent Safety Measures) will be collected, monitored and reported accordingly to the Sponsor\u0026rsquo;s Delegate, relevant ethic committee(s) and Research Governance Office(s). The safety reporting procedures will follow the latest version of The ARC Trial Safety Management Plan.\u003c/p\u003e\n\u003cp\u003eAn independent Data Safety and Monitoring Committee (DSMC) will conduct an annual review of the trial data to assess participant safety and study integrity, providing recommendations on whether to continue, modify, or stop the trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe DSMC will have access to unblinded data and data on the primary outcome, AEs (after coding) and SAEs. Data on complications will be recorded as outcomes and the DSMC will assess their severity and frequency.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFrequency and plans for auditing trial conduct {23}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRegular central monitoring of recruitment rates, withdrawals, protocol deviations, safety reports and data quality concerns by the study officer is planned and will be discussed by the Trial Management Group and/or the Steering Committee or DSMC meetings, with the outcomes of all meetings documented via meeting minutes. A yearly monitoring report will be submitted to the trial Sponsor.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAny protocol amendments are approved by the Trial Management Group (TMG), which is chaired by the Sponsor\u0026rsquo;s delegate, the Coordinating Principal Investigator. All\u0026nbsp;significant\u0026nbsp;changes\u0026nbsp;to the protocol\u0026nbsp;will\u0026nbsp;be\u0026nbsp;submitted\u0026nbsp;to\u0026nbsp;the\u0026nbsp;relevant\u0026nbsp;human\u0026nbsp;research\u0026nbsp;ethics\u0026nbsp;committee\u0026nbsp;and communicated to all sites and investigators once approved. All protocol amendment submission and approvals are filed in the Investigator Site Files as per GCP. Any protocol changes are updated in the ANZCTR registry.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Writing Committee will draft all manuscripts prior to review by other investigators and comprises IAH, RP, RB, JD. Authorship of all manuscripts will be granted according to ICJME guidelines.\u003c/p\u003e\n\u003cp\u003eStudy results will be published in a scientific journal and presented at international meetings. Media coverage will be promoted and sought to more widely communicate the results. The trial involves many opinion leaders in shoulder surgery nationally and internationally and has been endorsed by the Shoulder and Elbow Society of Australia (surgeons) and ANZMUSC (a musculoskeletal clinical trials network of clinicians, researchers and consumers); working with members of these groups will facilitate incorporation into practice guidelines and the day-to-day practice of clinicians.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe ARC trial will generate new, low bias evidence on the efficacy of rotator cuff repair for patients with chronic shoulder pain and non-acute (degenerative) rotator cuff tears by using a high-fidelity placebo control to isolate the active ingredient of the surgery (cuff repair) and by maximizing blinding of patients, carers, health care providers and investigators.\u003c/p\u003e"},{"header":"Trial status","content":"\u003cp\u003eThis manuscript is based on Version 16 of the protocol (15 July 2024). Recruitment began in April 2021 and is expected to be complete by April 2026.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eAE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Adverse event\u003c/p\u003e\n\u003cp\u003eANZMUSC\u0026nbsp; \u0026nbsp;\u0026nbsp;Australia and New Zealand Musculoskeletal Clinical Trials Network\u003c/p\u003e\n\u003cp\u003eARC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Australian Rotator Cuff (trial)\u003c/p\u003e\n\u003cp\u003eDSMC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Data Safety and Monitoring Committee\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEQ-5D-5L\u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;EuroQol 5-domain, 5-level quality of life survey\u003c/p\u003e\n\u003cp\u003eEQ-VAS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;EuroQol visual analogue scale\u003c/p\u003e\n\u003cp\u003eMRI\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Magnetic resonance imaging\u003c/p\u003e\n\u003cp\u003eRCT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Randomised controlled trial\u003c/p\u003e\n\u003cp\u003eSAE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Serious adverse event\u003c/p\u003e\n\u003cp\u003eTMG\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Trial Management Group\u003c/p\u003e\n\u003cp\u003eWHO\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;World Health Organization\u003c/p\u003e\n\u003cp\u003eWORC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Western Ontario Rotator Cuff Index\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions {31b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIAH is the Principal Investigator and conceived the study and drafted the protocol. JD is the study statistician and contributed to the statistical analysis. All authors contributed to and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding {4}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study is funded by the Whitlam Orthopaedic Research Centre, a not-for-profit charitable gift recipient organisation. The funding organisation has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll investigators will have access to the final dataset. There are no contractual agreements limiting access for investigators. The final dataset will be available after study publication upon reasonable request. The protocol and statistical analysis plan will be published.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate {24}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;study\u0026nbsp;protocol\u0026nbsp;version\u0026nbsp;6.0\u0026nbsp;28\u0026nbsp;May\u0026nbsp;2020\u0026nbsp;was\u0026nbsp;approved\u0026nbsp;by\u0026nbsp;the\u0026nbsp;Human Research Ethics Committees\u0026nbsp;of\u0026nbsp;the\u0026nbsp;South\u0026nbsp;Western Sydney Local Health District on 15 June 2020 (reference number 2020/ETH00754 ) and St John of God Health Care on 18 August 2020 (reference number 1704). Each update to the protocol has been approved by the relevant ethics committee.\u003c/p\u003e\n\u003cp\u003eThe study will be performed according to the National Statement on Ethical Conduct in Human Research.\u003csup\u003e49,50\u003c/sup\u003e As per the National Statement (2018 and 2023, section 3.1.5), placebo controlled\u0026nbsp;trials\u0026nbsp;are\u0026nbsp;ethically\u0026nbsp;acceptable\u0026nbsp;where\u0026nbsp;the\u0026nbsp;current\u0026nbsp;standard\u0026nbsp;of\u0026nbsp;care\u0026nbsp;includes\u0026nbsp;the\u0026nbsp;absence of the intervention being tested and there is no risk of significant harm in the absence of the intervention. All investigators will undergo training in Good Clinical Practice for clinical trials and will complete a study start up site or remote visit that involves training of the site principal investigator\u0026nbsp;and\u0026nbsp;all\u0026nbsp;delegated\u0026nbsp;personnel,\u0026nbsp;on\u0026nbsp;the\u0026nbsp;approved\u0026nbsp;versions\u0026nbsp;of\u0026nbsp;the\u0026nbsp;trial\u0026nbsp;protocol,\u0026nbsp;standard operating procedures and/or relevant essential documents. The protocol and a statistical analysis\u0026nbsp;plan will\u0026nbsp;be\u0026nbsp;published\u0026nbsp;in\u0026nbsp;an open-access journal.\u0026nbsp;The\u0026nbsp;protocol complies\u0026nbsp;with\u0026nbsp;SPIRIT guidelines\u003csup\u003e51\u003c/sup\u003e and the study will be reported according to the CONSORT guidelines.\u003csup\u003e48\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication {32}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA model consent form and participant information sheet have been provided as Supplementary Material.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSher JS, Uribe JW, Posada A, et al. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1995;77:10-5.\u003c/li\u003e\n\u003cli\u003eYamamoto A, Takagishi K, Osawa T, et al. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg 2010;19:116-20.\u003c/li\u003e\n\u003cli\u003eChard MD, Hazleman R, Hazleman BL, et al. Shoulder disorders in the elderly: A community survey. Arthritis \u0026amp; Rheumatism. 1991;34:766-69. doi: doi:10.1002/art.1780340619.\u003c/li\u003e\n\u003cli\u003eHill CL, Gill TK, Shanahan EM, et al. Prevalence and correlates of shoulder pain and stiffness in a population-based study: the North West Adelaide Health Study. Int J Rheum Dis. 2010;13:215-22.\u003c/li\u003e\n\u003cli\u003eÖstör AJK, Prevost AT, Hazleman BL, et al. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology 2005;44:800-05.\u003c/li\u003e\n\u003cli\u003eLuime JJ, Koes BW, Hendriksen IJ, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33:73-81. \u003c/li\u003e\n\u003cli\u003eBeard DJ, Rees JL, Cook JA, et al. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018;391:329-38.\u003c/li\u003e\n\u003cli\u003eKarjalainen TV, Jain NB, Page CM, et al. Subacromial decompression surgery for rotator cuff disease. Cochrane Database Syst Rev. 2019;1:CD005619.\u003c/li\u003e\n\u003cli\u003ePaavola M, Malmivaara A, Taimela S, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ. 2018;362:k2860.\u003c/li\u003e\n\u003cli\u003eVandvik PO, L\u0026auml;hdeoja T, Ardern C, et al. Subacromial decompression surgery for adults with shoulder pain: a clinical practice guideline. BMJ. 2019;364:l294.\u003c/li\u003e\n\u003cli\u003eAagaard KE, Abu-Zidan F, Lunsjo K. High incidence of acute full-thickness rotator cuff tears. Acta Orthop. 2015;86(5):558-62 \u003c/li\u003e\n\u003cli\u003eColvin AC, Egorova N, Harrison AK, et al. National trends in rotator cuff repair. J Bone Joint Surg Am. 2012;94:227-33.\u003c/li\u003e\n\u003cli\u003eEnsor KL, Kwon YW, Dibeneditto MR, et al. The rising incidence of rotator cuff repairs. J Shoulder Elbow Surg 2013;22:1628-32. \u003c/li\u003e\n\u003cli\u003eJo YH, Lee KH, Kim SJ, et al. National trends in surgery for rotator cuff disease in Korea. J Korean Med Sci. 2017;32:357-64. \u003c/li\u003e\n\u003cli\u003eMather RC, 3rd, Koenig L, Acevedo D, et al. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am. 2013;95:1993-2000.\u003c/li\u003e\n\u003cli\u003eThorpe A, Hurworth M, O\u0026apos;Sullivan P, et al. Rising trends in surgery for rotator cuff disease in Western Australia. ANZ J Surg. 2016;86:801-04. \u003c/li\u003e\n\u003cli\u003eYanik EL, Chamberlain AM, Keener JD. Trends in rotator cuff repair rates and comorbidity burden among commercially insured patients younger than the age of 65 years, United States 2007-2016. JSES Rev Rep Tech 2021;1:309-16. \u003c/li\u003e\n\u003cli\u003eKarjalainen TV, Jain NB, Heikkinen J, et al. Surgery for rotator cuff tears. Cochrane Database Syst Rev. 2019;12:CD013502.\u003c/li\u003e\n\u003cli\u003eKukkonen J, Joukainen A, Lehtinen J, et al. Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results. Bone Joint J. 2014;96:75-81. \u003c/li\u003e\n\u003cli\u003eLambers Heerspink FO, van Raay JJ, Koorevaar RC, et al. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial. J Shoulder Elbow Surg. 2015;24:1274-81.\u003c/li\u003e\n\u003cli\u003eMoosmayer S, Lund G, Seljom U, et al. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up. J Bone Joint Surg Br. 2010;92:83-91.\u003c/li\u003e\n\u003cli\u003eJeong HJ, Nam KP, Yeo JH, et al. Retear After Arthroscopic Rotator Cuff Repair Results in Functional Outcome Deterioration Over Time. Arthroscopy. 2022;38(8):2399-412\u003c/li\u003e\n\u003cli\u003eKim YS, Kim SE, Bae SH, et al. Tear progression of symptomatic full-thickness and partial-thickness rotator cuff tears as measured by repeated MRI. Knee Surg Sports Traumatol Arthrosc. 2017;25:2073-80.\u003c/li\u003e\n\u003cli\u003eRussell RD, Knight JR, Mulligan E, et al. Structural integrity after rotator cuff repair does not correlate with patient function and pain: a meta-analysis. J Bone Joint Surg Am. 2014;96(4):265-71. \u003c/li\u003e\n\u003cli\u003eDunn WR, Schackman BR, Walsh C, et al. Variation in orthopaedic surgeons\u0026apos; perceptions about the indications for rotator cuff surgery. J Bone Joint Surg Am. 2005;87:1978-84. \u003c/li\u003e\n\u003cli\u003eWang A, Mackie K, Bain G, et al. Variation in treatment of rotator cuff injury within a subspecialist shoulder society. In: SESA, ed. Shoulder and Elbow Society of Australia (SESA) Biennial Meeting. Perth, 2018.\u003c/li\u003e\n\u003cli\u003eRangan A, Upadhaya S, Regan S, et al. Research priorities for shoulder surgery: results of the 2015 James Lind Alliance patient and clinician priority setting partnership. BMJ Open. 2016;6:e010412.\u003c/li\u003e\n\u003cli\u003eSomerson JS, Hsu JE, Gorbaty JD, et al. Classifications in Brief: Goutallier Classification of Fatty Infiltration of the Rotator Cuff Musculature. Clin Orthop Relat Res. 2016;474(5):1328-32. \u003c/li\u003e\n\u003cli\u003eSlattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018;476:2101-04. \u003c/li\u003e\n\u003cli\u003eHarris I, Mulford J, Solomon M, et al. Association between compensation status and outcome after surgery: a meta-analysis. JAMA. 2005;293:1644-52.\u003c/li\u003e\n\u003cli\u003eBeard DJ, Campbell MK, Blazeby JM, et al. Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet. 2020;395:828-38. \u003c/li\u003e\n\u003cli\u003eThigpen CA, Shaffer MA, Gaunt BW, et al. The American Society of Shoulder and Elbow Therapists\u0026apos; consensus statement on rehabilitation following arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016;25:521-35. \u003c/li\u003e\n\u003cli\u003eRyosa A, Kukkonen J, Bjornsson Hallgren HC, et al. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019;9:e025022.\u003c/li\u003e\n\u003cli\u003eKirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003;13:84-92. \u003c/li\u003e\n\u003cli\u003eHuang H, Grant JA, Miller BS, et al. A systematic review of the psychometric properties of patient-reported outcome instruments for use in patients with rotator cuff disease. Am J Sports Med. 2015;43:2572-82.\u003c/li\u003e\n\u003cli\u003ede Witte PB, Henseler JF, Nagels J, et al. The Western Ontario rotator cuff index in rotator cuff disease patients: a comprehensive reliability and responsiveness validation study. Am J Sports Med. 2012;40:1611-9. \u003c/li\u003e\n\u003cli\u003eBuscayret F, Edwards TB, Szabo I, et al. Glenohumeral arthrosis in anterior instability before and after surgical treatment: incidence and contributing factors. Am J Sports Med. 2004;32:1165-72.\u003c/li\u003e\n\u003cli\u003eRamiro S, Page MJ, Whittle SL, et al. The OMERACT core domain set for clinical trials of shoulder disorders. J Rheumatol. 2019;46:969-75. \u003c/li\u003e\n\u003cli\u003eHansford HJ, Buchbinder R, Zadro JR, et al. The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study. medRxiv, 2024. https://www.medrxiv.org/content/10.1101/2024.07.24.24310953v1. Accessed 5 September 2024.\u003c/li\u003e\n\u003cli\u003eBraun C, Handoll HH. Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears. Musculoskelet Sci Pract. 2018;35:30-3.\u003c/li\u003e\n\u003cli\u003eJones IA, Togashi R, Heckmann N, et al. Minimal clinically important difference (MCID) for patient-reported shoulder outcomes. J Shoulder Elbow Surg. 2020;29:1484-92. \u003c/li\u003e\n\u003cli\u003eEkeberg OM, Bautz-Holter E, Keller A, et al. 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Arthroscopy. 2005;21:1307-16.\u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap) \u0026ndash; A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377-81.\u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Minor BL, et al. The REDCap consortium: building an international community of software partners. J Biomed Inform. 2019;95:103208.\u003c/li\u003e\n\u003cli\u003eSchulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.\u003c/li\u003e\n\u003cli\u003eNational Health and Medical Research Council, Australian Research Council, Universities Australia. National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Canberra: National Health and Medical Research Council, 2018.\u003c/li\u003e\n\u003cli\u003eNational Health and Medical Research Council, Australian Research Council, Universities Australia. National Statement on Ethical Conduct in Human Research. Canberra: National Health and Medical Research Council, 2023.\u003c/li\u003e\n\u003cli\u003eChan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200-207.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Clinical trials, rotator cuff, shoulder, surgery, placebo","lastPublishedDoi":"10.21203/rs.3.rs-5040867/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5040867/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eDegenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full thickness degenerative rotator cuff tears.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40\u0026ndash;75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including \u0026ndash; as indicated \u0026ndash; bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists study staff and statisticians will all be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eThe trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).\u003c/p\u003e","manuscriptTitle":"ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-26 08:25:39","doi":"10.21203/rs.3.rs-5040867/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Accept","date":"2025-03-20T02:25:28+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-03-18T10:34:25+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-18T10:33:29+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-18T09:08:38+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-03-18T02:53:11+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1da26782-0aa1-4120-9a5d-b0f7b8429303","owner":[],"postedDate":"March 26th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-04-07T16:04:07+00:00","versionOfRecord":{"articleIdentity":"rs-5040867","link":"https://doi.org/10.1186/s13063-025-08822-w","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-04-02 15:57:34","publishedOnDateReadable":"April 2nd, 2025"},"versionCreatedAt":"2025-03-26 08:25:39","video":"","vorDoi":"10.1186/s13063-025-08822-w","vorDoiUrl":"https://doi.org/10.1186/s13063-025-08822-w","workflowStages":[]},"version":"v1","identity":"rs-5040867","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5040867","identity":"rs-5040867","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}