Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: Young shoulder CARE (displaCed proximAl humerRus fractueE) trial - a study protocol for a pragmatic randomized controlled trial

Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: Young shoulder CARE (displaCed proximAl humerRus fractueE) trial - a study protocol for a pragmatic randomized controlled trial | 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 Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: Young shoulder CARE (displaCed proximAl humerRus fractueE) trial - a study protocol for a pragmatic randomized controlled trial Line Houkjær, Antti Launonen, Bakir Sumrein, Laura Kärnä, Zaid Issa, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7603307/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 29 Dec, 2025 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background: Proximal humerus fractures (PHF) are common in adults above 50 years, often following low-energy trauma and underlying osteoporosis. Randomized trials in patients 60 years and older have found no clinically important difference in one- and two-year outcomes between surgical and non-surgical treatments. There is limited evidence for the 50–65 age group, who may have different functional demands and even a different overall health status. There is limited knowledge to guide treatment decisions for this age group. Method: A multicenter, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment in patients aged 50–65 years with displaced PHF. A total of 60 patients will be randomized equally to surgical treatment (primary osteosynthesis) or non-surgical treatment. Follow up visits are arranged at 6 weeks and 6 months for all patients, with an additional 12-week visit mandatory for the surgical group and optional for the non-surgical group. The primary outcome is Oxford Shoulder Score at 12 months. In case of treatment failure (persistent pain or a failed osteosynthesis), a salvage procedure will be offered. Non-randomised cohort will have baseline data and preferences recorded, and they will receive the same follow-up and outcome assessments. Discussion: Young Shoulder CARE trial aims to provide insights into the treatment of displaced proximal humerus fractures in patients aged 50-65 years, and to understand the benefits and harms of both surgical and non-surgical treatment options. The trial results will be published in an open-access peer-reviewed journal. Trial registration: Clinicaltrials.gov, NCT06416618, registered 14 May 2024. Shoulder fractures Patient Reported Outcome Measures middle aged orthopaedic procedures outcome assessment Figures Figure 1 Figure 2 Background Proximal humerus fractures (PHF) are common injuries with an incidence of 138 per 100,000 person-years in adults aged 18 years and above in Denmark, increasing with age and have remained stable over decades [1]. In Denmark (2018) the total annual number of PHF was 6,318 (72 % women) [1]. In Finland (2019), the incidence among individuals aged over 16 years was 105 per 100,000. The incidence was higher in females and increased with age, particularly among those aged 50 years and older. The total annual number in 2019 was 4,826 cases [2]. Less than half of the fractures are minimally displaced [3, 4], with displaced fractures defined as at least one of Codman’s four anatomic segments being displaced by ≥1 cm or angulated ≥45° (as defined by Neer [5]). Meta-analyses comparing surgical and non‑surgical treatments for PHF have been rated as having critically low methodological quality [6]. A Cochrane review reported high‐certainty evidence of no clinically important difference between surgical and non‐surgical treatment in patient‐reported shoulder function one and two years after injury [7]. Most included studies focus on older patients; however, a subgroup analysis (aged 16-65) from the ProFHER study [8] found no statistically significant differences in patient-reported shoulder function (Oxford Shoulder Score (OSS)) between surgical and non-surgical treatment at 6 months, one year and two years. There was a trend toward more rapid improvement among younger patients (< 65 years) in the non-surgical group compared to those in the surgical group. This study focuses on patients aged 50-65. Individuals in this age group often differ from older adults in terms of functional demands, work status, overall health, and rehabilitation expectations. PHF is uncommon in patients below the age of 50, whereas incidence increases markedly from this age and onward [1,2]. More than 80 % of the fractures occurred in patients above 50 years [6], in females [1,2,9] and results from low-energy trauma [3,9,10]. Stratification by sex reveals a female predominance from the age of 50 [1,2,6], which coincides with an increase in age-related decrease of bone mineral density [11,12]. The exact prevalence of osteoporosis in the general population is not precisely known, as detection often relies on bone mineral density measurements, which are not routinely performed. Reduced bone mineral density is a known risk factor for complications following osteosynthesis [13,14]. The surgical treatment of choice for displaced PHF in adults 50-65 years is anatomical reduction followed by osteosynthesis if possible [15-17]. Surgical options include internal fixation with locking plates, intramedullary nails, or joint replacement with hemiarthroplasty, or reverse shoulder arthroplasty. Complication and reoperation rates are high after surgery [18]. Orthopaedic surgeons may encounter challenges in making treatment decisions with patients in this specific age group, as existing randomized trials have predominantly focused on older individuals[19]. There is an intermediate age group of patients for whom it remains uncertain whether surgical intervention is superior to non-surgical management in terms of benefits and harms. The aim of this study is to assess whether osteosynthesis results in superior patient-reported shoulder function compared to non-surgical treatment, as measured by the Oxford Shoulder Score at 12 months, in patients aged 50 to 65 years with displaced proximal humerus fractures. Methods: Patients, Intervention, and Outcomes Study design The study is a two-center, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment following a displaced PHF in patients aged 50-65 years with a 1:1 allocation ratio. The protocol will follow the PREPARE trial guide [20] and the SPIRIT checklist [21]. The study will be reported according to the CONSORT NPT checklist [22]. The statistical analysis plan (Supplementary information, file 1) will follow the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials [23]. All checklists are available in Supplementary Information, file 2. The trial flow and timeline for data collection are outlined in Figures 1 and 2. Participants Patients will be recruited from the orthopaedic departments at Zealand University Hospital in Denmark and Tampere University Hospital in Finland. The following inclusion criteria will apply: Patients aged between 50 and 65 years with a displaced proximal humerus fracture after a low-energy trauma. Patients should be cognitively capable of answering the follow-up questionnaires. The following exclusion criteria will apply: Communication: The patient does not understand written and spoken native language (Danish or Finnish) Inability to give informed consent Fracture criteria: Fractures assessed to be non-reconstructable by the treating surgeon Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks postinjury Pathological fractures or previous fractures in the same proximal humerus Concomitant fractures, which could influence the outcome Other criteria: Paralysis of the upper extremity Recruitment Patients admitted to the emergency department will be clinically examined by the emergency doctor. Two perpendicular plain radiographs will be obtained. If a displaced PHF is diagnosed, the patient will be referred to the outpatient clinic within two weeks postinjury. Patients will be screened for eligibility based on the initial radiographs and medical records by the investigator at the clinic. During the first visit to the outpatient clinic, the patient will be informed about the study. Potential participants will receive verbal and written information about the study from the local investigator. If eligible and consenting to participate, the local investigator will provide face-to-face trial instructions, and informed consent will be obtained. Non-randomized cohort Eligible patients who decline participation will be recorded; when possible, their reasons for declining will be noted. These patients will be invited to participate in the non-randomised cohort. The patient can choose surgery only if recommended by the surgeon; such cases will be reported. Patients in the non-randomized cohort who provide informed consent will participate in the same treatment, rehabilitation, follow-up and outcome assessments as the randomized cohort, with data recorded for research purposes. Randomization and concealment of allocation We will use Research Electronic Data Capture (REDCap) [24] to generate an irreversible randomization sequence. A person not involved in the project will generate and upload the allocation table using 'R'. All investigators will be blinded to the allocation table. The person not involved in the project will have no access, including no access to the data. We will be using block randomization, including location stratification (shifting block sizes of 4 and 6 in each block). REDCap will conceal the sequence for the investigators before allocation takes place. Enrolment and allocation will occur on-site by LH, AL, BS, or LK. A REDCap built-in functionality ensures that only patients who meet all inclusion and no exclusion criteria can be randomized. Intervention All patients will receive standard pain management following local guidelines and will be provided with a sling and swathe on the day of the injury in the emergency room. After 10 to 14 days, all patients will undergo evaluation in the outpatient clinic. Surgical group : The surgical group will receive osteosynthesis with a locking plate or an intramedullary locking nail, according to the surgeon’s preference. The patients will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail. Non-surgical group : Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1–2 weeks at their first visit, 10-14 days post-injury. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments. If there is still severe pain at week 6, it is considered a treatment failure. Severe pain is defined as being unable to sleep due to pain and/or requiring opioids to manage it (without opioid use prior to injury). If there is little progress but moderate pain, an additional consultation can be provided 12 weeks post-injury with clinical and radiological follow-up. Both groups : Patients will be offered standard 6-month radiographs and clinical assessments, as well as a diagnostic workup for osteoporosis with a DXA scan. Osteopenia is defined as a T-score between -2.5 and -1. Osteoporosis is defined as a T-score lower than or equal to -2.5. [25] Additionally, osteoporosis can be diagnosed by hip and spine fractures, which, in Denmark, is considered pathognomonic for osteoporosis Boths groups will be referred to post-operative rehabilitation in the municipalities. (Supplementary information, file 3 – Rehabilitation). The rehabilitation program is similar, starting post-surgery for the surgical group and from the time of injury for the non-surgical group. The duration, intensity, and exercises used will be tailored in collaboration between the patients and the physiotherapist. Rehabilitation typically lasts 6-12 weeks. Adherence to rehabilitation is defined as completing at least 6 weeks of rehabilitation and following rehabilitation protocol. Treatment failure: In case of treatment failure in either group, defined as persistent pain or a failed osteosynthesis, a salvage procedure with secondary osteosynthesis, including the possibility to use a locking plate with a graft or a reverse shoulder arthroplasty (RSA), will be offered. Failed osteosynthesis and the most appropriate salvage procedure will be defined by the surgeon. Cross-over to reverse shoulder arthroplasty or revision osteosynthesis is considered a failure of treatment regardless of group allocation. The patient will remain in the study. The reason for crossing over will be noted and reported. Strategies to improve retention Patients will receive a phone number to contact the local investigator with any questions. All included patients will be seen by either LH, SB, AL, BS, or LK at all appointments. Follow-up is planned at 6, 12, and 24 months. The 6-month follow-up includes radiographs, clinical assessment (range of motion, strength, and test for subacromial pain), and questionnaires. Data will be stored using Research Electronic Data Capture (REDCap) [24]. At the 12 and 24-month follow-ups, questionnaires will be automatically sent by REDCap for patients to complete from home, provided the patient has a mailing address. Patients are asked to accept telephone calls if they miss follow-up visits to promote patient retention and complete follow-up. Reminders will be sent 2 and 4 weeks after receiving their 12 and 24-month questionnaires. After 6 weeks, completion by phone will be offered if still unanswered [26]. Outcome The primary outcome will be the OSS at 12-months. The secondary outcome will be OSS at 6- and 24- month and EQ-5D-3L score measured at the 6-, 12- and 24 months. Secondary outcomes will include the incidence of adverse events in all groups and the rate of conversion to surgery in nonoperative group. Oxford Shoulder Score (OSS) OSS is a patient-reported shoulder-specific outcome measure to assess shoulder function. It consists of 12 questions on a 5-point Likert scale (both pain- and function-related), each offering five ordinal response options. The cumulative score ranges between 0 and 48, being 0 (worst) to 48 (best: no pain or functional limitation). The questionnaire includes a mix of functional ability and pain-related questions. It is validated in adults with shoulder pain from a degenerative or inflammatory condition (median age 57.4 in UK) [27], and in Denmark in patients with post-traumatic shoulder diseases, including impingement and sequelae after PHF [28]. Patients in follow-up cohorts does not need to attend the clinic in person to complete the OSS [28]. Quality of life (EQ-5D-3L) EQ-5D-3L is a generic health-related quality-of-life assessment tool validated as a quality of life measure in patients with PHF [29]. It consists of a 5-dimension descriptive questionnaire about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as a measure for health-related quality of life [30]. Each dimension has 3 levels: No problems, some/moderate problems, and unable/extreme problems. Each dimension is weighted differently and results in a total score based on the EQ-5D index calculator (TTO). The EQ-5D-3L also includes an overall scale (numeric rating scale) in which patient rates their overall health condition today on a scale between 1 - 100, with 100 being the highest level of health imaginable. Adverse events: Serious adverse events, as defined by the WHO [31], will be reported to a data monitoring committee (DMC). These events are defined as those leading to death, being life-threatening, requiring inpatient hospitalization, or necessitating reoperation. Other adverse events, whether surgical or non-surgical related, will also be reported. Systematic reviews on terms and definitions for complications after surgical [32] and non-surgical treatment [33] have been conducted. Based on international consensus on the core event set for PHF, both surgical and non-surgical treatments, eight event groups are defined [34]. The following adverse event groups will be monitored: implant, osteochondral, shoulder instability, peripheral neurology, vascular, infection, device, superficial soft tissue, and deep soft tissue. In addition to this, we have chosen to monitor clinical symptoms such as persistent severe pain. The event groups are elucidated in Supplementary information, file 4 – Complications. Conversion to surgery: The criteria for conversion to surgery are based on an overall clinical evaluation conducted in collaboration with the patient. In the non-surgical group, the primary reason for conversion is persistent severe pain after 6-12 weeks. In the surgery group, adverse events can serve as reasons for conversion to RSA. Patients who discontinue for reasons unrelated to surgery will be documented and recorded. Patients receiving osteosynthesis or RSA will also have follow-up assessments after 6, 12, and 24 months. Statistical methods Hypothesis The null hypothesis is that the shoulder function measured with OSS 12 months after surgery is not superior to non-surgical treatment. The alternative hypothesis is that the shoulder function measured with OSS 12 months after surgery is superior to non-surgical treatment. Sample size and power considerations The standard deviation (SD) has been reported as 12 for OSS [35]. The Minimal Clinically Important Difference (MCID) for the OSS (0-48) is in the range of 5–6.9 in various shoulder diseases, age groups, and assessment points – but has not been established for PHF [35->36]. Without a patient-derived MCID for PHF, a relevant difference of 9,6 was assumed to represent a clinically meaningful difference. This corresponds to approximately a 20% difference between the surgical group and the non-surgical group on a 0–48 OSS scale. With a power of 80% and a 5% level of significance, a sample size of 25 patients per group is required. Assuming a 15% loss to follow-up, the recruitment target is 30 patients in each group, resulting in a total of 60 patients. The recruitment period is expected to be 24 months. Statistical analysis The statistical analysis plan is available within Supplementary Information, file 1. Baseline characteristics will be presented using descriptive statistics. We will compare the following patient characteristics between the groups at baseline: age (categorized into 5-year age groups), sex, height, weight, ASA score, fracture classification (Neer [5]), dominant arm (yes/no), smoking, alcohol consumption, educational level, working status, work type, osteoporosis (three-level ordinal variable based on T-scores (osteoporosis, osteopenia, and normal bone density)) and clinical frailty scale [37]. SD will be reported, and n (%) for categorical values. Osteoporosis will be collected and reported descriptively as a three-level ordinal variable based on T-scores (osteoporosis, osteopenia, and normal bone density). The OSS results for surgical and non-surgical treatment groups at 6, 12, and 24 months will be tabulated and graphically represented with mean, SD, median, and IQR according to the distribution. The primary outcome, OSS at 12 months, will be analysed using two-sample t-test comparing the two treatment groups. Normality assumptions will be assessed, and if violated, alternative methods such as transformation or non-parametric Mann–Whitney U test will be considered. As suggested in the extension of the CONSORT 2010 statement, the primary outcome will be analysed for the intention-to-treat (ITT) population. In addition, linear mixed models will be used to analyse OSS and EQ-5D over time (6, 12 and 24 months) accounting for the repeated measures structure and to explore outcome trajectories. Model-based contrasts from the LMM will be used to estimate adjusted between-group differences at specific time points. Missing data will be handled within the mixed model framework, assuming data are missing at random. Details are provided in Supplementary Information, file 4. We will record and report adverse events in each group. At the 6-month follow-up, patients will be asked, and we will record and report the length of rehabilitation in municipalities (in weeks) and whether the patient has followed the rehabilitation plan. Salvage procedure Salvage procedures and adverse events will be reported descriptively. Reoperation in the form of hardware removal will be classified as a complication, not a salvage procedure. There will be two analyses for ITT: one including salvage procedures and one excluding them. The timing of salvage procedures will be analyzed using a Cox proportional hazards model to compare time to salvage between treatment groups. Non-randomized cohort Patients who declined randomization but consented to follow-up will form the non-randomized cohort. Baseline characteristics will be summarized descriptively and compared between the randomized and non-randomized cohorts, as well as among the non-randomized patients by treatment choice. The primary outcome (OSS at 12 months) will be analyzed by treatment modality. Secondary outcome measures (OSS and EQ-5D) will be presented descriptively and graphically at 6, 12, and 24 months. Analyses will include multivariable linear regression adjusted for baseline covariates; propensity score methods may be applied. The incidence and timing of salvage procedures will be described and analyzed using Cox proportional hazards models. Blinded data interpretation Although patients and investigators are not blinded to treatment allocation, the primary investigator will conduct blinded statistical analysis through data anonymization and will be supervised by a biostatistician. The OSS and EQ-5D-3L will be completed just before the 6-month visit, collected automatically through REDCap, and will not be reviewed by the investigator prior to analysis- After the blinded statistical analysis has been completed, two abstracts will be written based on the pre-blinding analysis results before the blinding is revealed. Data will be analysed using the statistical “R” [38]. Interim analyses An interim analysis will be conducted when 50% (n = 30) of the randomized patients have completed their 6-month follow-up, focusing on OSS, failure to treatment, and serious complications. A third party will blind the data to treatment location before analysis. Regardless of whether the interim analyses suggest that the study is unlikely to achieve its primary objectives, the study will proceed as initially planned. A DMC has been organized to monitor and evaluate the data from the interim analysis. The DMC consists of four independent members, including four orthopedic researchers and an orthopedic nurse. The DMC will monitor unexpected, unwanted events; continued inclusion will be considered if the failure rate is above 30 %. Intervention-related hospitalization or mortality will be reported to the ethics committee. Data management All study data will be collected and stored in Research Electronic Data Capture (REDCap) [24]. Clinical assessments and radiographs will be entered directly into REDCap by the investigators (LH, SB, AL, BS, or LK). Questionnaires at 12 and 24 months will be distributed electronically through REDCap. Data will be stored securely on institutional servers with access restricted to study personnel. Protocol violation Patients who drop out of the trial will be noted, along with the reasons. The patients will remain in the study and be included in the ITT analysis. Numbers and time for loss to follow up will be reported. Patient and public involvement Four patients read and commented on the written information sheet, confirming the understandability and that it was sufficiently informative. Discussion Relevance of Age in Existing Evidence Current high-quality evidence on proximal humerus fracture treatment primarily concerns patients from 60 or above. This leaves a knowledge gap in the younger, still working-age population aged 50–65. A Cochrane review reported high- or moderate-certainty evidence that surgery, compared to non-surgical treatment after a displaced proximal humerus fracture, did not provide a better outcome after one and two years [ 7 ]. However, patients aged 50–65 may differ in functional demands, health status, and recovery expectations. Despite this, they are typically underrepresented in clinical trials. The Young Shoulder CARE trial was designed to contribute to addressing this evidence gap. By focusing exclusively on patients aged 50–65, the trial aims to generate age-specific data to inform clinical decision-making for this population better. The pragmatic design was chosen to reflect real-world clinical practice and increase external validity. Defining “older adults” There is no universally agreed-upon age cut-off for what constitutes an "older" adult; yet age definitions are crucial in trial inclusion and generalizability. WHO previously characterized older people as those over 65 years (2010 report), the latest age report has no precise definition. The term "older" is too complex due to multiple factors and variations in global age distribution, making it challenging to establish an age cutoff [ 39 ]. The Danish Health Authority [ 40 ] and International Population Report of the National Institutes of Health [ 41 ], defines “older” as individuals surpassing the age of 65. In orthopaedic research, Sabharwal found that age 65 is the most common age at which a person is considered "older” [ 42 ]. We aimed to investigate a population that differs from older adults in terms of functional demands, general health status, and expectations for recovery. To ensure the inclusion of individuals who are still active in the workforce, we focused on patients below the typical retirement age. In Finland and Denmark, the retirement age is 65–67 years [43, 44]. Consequently, we selected 65 years as the upper age limit to target a relatively younger and more active patient group. This allows our trial to clearly complement and extend existing evidence focused on older adults. MCID A MCID for the OSS in patients with PHF has not been established. MCID for the OSS (0–48) is 5–6.9 in various shoulder conditions [ 36 ]. However, the concept of MCID is inherently context-dependent and may vary according to patient characteristics such as age, sex, baseline function, injury mechanism, comorbidities - and may also change over time [ 45 ]. As such, the MCID should not be regarded as a fixed value. In the absence of a MCID specific for the population, we defined a difference of 9.6 points on the OSS—equivalent to 20% of the scale—as clinically meaningful for this trial. This threshold was used for the sample size calculation, reflecting the view that surgical treatment should yield a substantial benefit to be considered appropriate. Future research should aim to validate or refine the MCID specific to PHFs. Abbreviations ASA American Society of Anesthesiologists Score DXA Dual-Energy X-ray Absorptiometry Scan EQ-5D-3L European Quality of Life – 5 dimensions – 3 levels ITT Intention to treat MCID Minimal Clinically Important Difference OSS Oxford Should Score PHF Proximal humerus fracture PROM Patient-reported outcome measure RCT Randomized controlled trial REDCap Research Electronic Data Capture SD Standard deviations SPIRIT The Standard Protocol Items:Recommendations for Interventional Trials WHO World Health Organization Declarations Permissions We have obtained permission to use Clinical Frailty Scale (ID: 20240125-13). We have obtained permission to use the Danish, Swedish and Finish version of Oxford Shoulder Score (00OSS-1643060) and the Danish, Swedish and Finish version of EQ-5D (Registration ID: 60840). Ethical approval and consent to participate The study will adhere to the ethical principles outlined in the Declaration of Helsinki. Participants will provide written, informed consent. Approval has been granted by the scientific ethics committees in Denmark (EMN-2024-01516) and Finland (ETL R24048) (Supplementary information, file 5). The Data Protection Agency has approved the handling of personal data (p-2024-16591). Any significant changes to the trial will be reported to the National Committee on Health Research Ethics in each country and registered on ClinicalTrials.gov. Substantial protocol modifications will be approved by the relevant ethics committee before implementation and communicated to investigators, the trial registry, and other relevant parties as appropriate. Consent for publication Not applicable Availability of data and materials Data sharing not applicable to this article as no datasets were generated or analysed during the current study. The Data Protection Agency of Region Zealand has approved the handling of personal data (p-2024-16591). Compliance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act will be ensured at all times. A data processing agreement has been signed in both recruiting centers. Research data is stored on REDCap, a secure online patient management program, accessible only to LH, SB, AL, BS, and L.K. on a secure server at Region Zealand University Hospital (with two-factor authentication login. The primary investigator will have access to the final data set. The REDCap setup ensures that randomization is only possible, if all baseline information is entered correctly. All data will be fully anonymized before publication. The trial results will be published in an open-access peer-reviewed journal. Competing interests The authors declare that they have no competing interests. Funding The trial is conducted as part of a PhD project, with tuition fees to the University of Copenhagen funded by the regional research fund Region Zealand Health Science Research Foundation [Region Sjællands Sundhedsvidenskabelige Forskningsfond]. The principal investigator (LH) is employed by the Department of Orthopedic Surgery, Zealand University Hospital, Køge, and is guaranteed a salary from the department throughout the PhD-period. The study has received partial funding from Region Zealand Health Science Research Foundation [Region Sjællands Sundhedsvidenskabelige Forskningsfond] (ref. R41‐A1846), Lippmann Fonden, and Spies Fonden (For grants and salary guarantee, see Supplementary information, file 6). Current and future funders have no role in the design, conduct, analysis, interpretation of data, or decision to submit results for publication. No commercial or industrial funding is involved. Both surgical and non-surgical devices are part of standard care and will be provided by the participating trial sites. Authors contributions The LH has initiated and designed the study in collaboration with SB. and AL. LH drafted the study protocol and BS, LK, ZI and KH contributed to the protocol refinement and approved the final version. LH, SB and AL will ensure the execution and completion of the project. LH and SB is recruiting in Køge, Denmark. AL, BS and LK is recruiting in Tampere, Finland. LH is the grant holder and takes overall responsibility for participant inclusion and data collection. LH will draft the manuscripts for study result publication with contributions and approval of final versions from AL, BS, LK, ZI, KH and SB. Acknowledgement We would like to thank Sahar Moeini for generation and upload of allocation table. The authors would like to thank Maria D. Nielsen, Janika Pietila, Marketta Rautanen for administrative support. 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Consensus statement on the treatment of proximal humerus fractures: a Delphi approach by the Neer Circle of the American Shoulder and Elbow Surgeons. J Shoulder Elbow Surg. 2025 Jan 22:S1058-2746(25)00065-5. doi: 10.1016/j.jse.2024.12.005 Oldrini LM, Feltri P, Albanese J, Marbach F, Filardo G, Candrian C. PHILOS Synthesis for Proximal Humerus Fractures Has High Complications and Reintervention Rates: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Feb 19;12(2):311. doi: 10.3390/life12020311. Lee G, Hasegawa I, Obana K, Min KS. Analyzing outcomes after proximal humerus fractures in patients <65 years: a systematic review and meta-analysis. JSES Rev Rep Tech. 2021 May 21;1(3):165-170. doi: 10.1016/j.xrrt.2021.04.014. Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586 Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40-47. Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017;318(23):2337-2343 Harris PA, Ph D, Taylor R, Thielke R, Ph D, Payne J, et al. Research Electronic Data Capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. 2010;42(2):377–381 Kanis JA on behalf of the World Health Organization Scientific Group. Assessment of osteoporosis at the primary health-care level. https://www.sheffield.ac.uk/FRAX/pdfs/WHO_Technical_Report.pdf (date last accessed 15 August 2024). Nakash RA, Hutton JL, Jørstad-Stein EC, Gates S, Lamb SE. Maximising response to postal questionnaires--a systematic review of randomised trials in health research. BMC Med Res Methodol. 2006;6:5. Published 2006 Feb 23. doi:10.1186/1471-2288-6-5 Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br 1996;78:593-600 Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011;58(11):A4335. visited 13-09-23 Olerud P, Tidermark J, Ponzer S, Ahrengart L, Bergström G. Responsiveness of the EQ-5D in patients with proximal humeral fractures. J Shoulder Elbow Surg. 2011 Dec;20(8):1200-6. doi: 10.1016/j.jse.2011.06.010. Epub 2011 Oct 20. PMID: 22014617. EQ-5D-3L: https://euroqol.org/eq-5d-instruments/eq-5d-3l-about/ (visited 03-07-2025) WHO: E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (europa.eu), visited 13-09-23 Alispahic, N., Brorson, S., Bahrs, C. et al. Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions. BMC Musculoskelet Disord 21, 327 (2020). https://doi.org/10.1186/s12891-020-03353-8 Brorson S, Alispahic N, Bahrs C, et al. Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions. BMC Musculoskelet Disord. 2019 Feb 23;20(1):91. doi: 10.1186/s12891-019-2459-6. Audigé, L., Brorson, S., Durchholz, H. et al. Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process. BMC Musculoskelet Disord 22, 1002 (2021). https://doi.org/10.1186/s12891-021-04887-1 Baker P, Nanda R, Goodchild L, Finn P, Rangan A. A comparison of the Constant and Oxford Shoulder Scores in patients with conservatively treated proximal humeral fractures.J Shoulder Elbow Surg. 2008;17(1):37-41 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. 10.1016/j.jse.2019.12.033 Rockwood K, Theou O. Using the clinical frailty scale in allocating scarce health care 12 resources. Can Geriatr J. 20bpo20;23(3):254–9 R Core Team (2021). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/ Ageing and Health, Demographic Change and Healthy Ageing, Social Determinants of Health by WHO 2015 https://www.who.int/publications/i/item/9789241565042 accessed 18.09.23 [https://www.sst.dk/-/media/Udgivelser/2019/%C3%86ldres-sundhed-og-trivsel.ashx 22-08-23] visited 03-07-2025 An Aging World: 2015 (census.gov) visited 22-08-23 Sabharwal S, Wilson H, Reilly P, Gupte CM. Heterogeneity of the definition of elderly age in current orthopaedic research. Springerplus. 2015 Sep 17;4:516. doi: 10.1186/s40064-015-1307-x. [https://star.dk/ydelser/pension-og-efterloen/folkepension-tidlig-pension-foertidspension-og-seniorpension/folkepension/folkepensionsalderen-nu-og-fremover] visited 03-07-2025 https://www.tyoelake.fi/en/different-pensions/old-age-pension-your-retirement-age-is-based-on-your-year-of-birth/ visited 03-07-2025 Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Man Manip Ther. 2012 Aug;20(3):160-6. doi: 10.1179/2042618612Y.0000000001 McNally, Martin A. et al. “The EBJIS definition of periprosthetic joint infection. The Bone & Joint Journal 103-B (2021): 18 - 25. Supplementary Files Sup.info14new.pdf Cite Share Download PDF Status: Published Journal Publication published 29 Dec, 2025 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 06 Oct, 2025 Reviewers invited by journal 06 Oct, 2025 Editor assigned by journal 06 Oct, 2025 First submitted to journal 29 Sep, 2025 Editorial decision: Minor revision 24 Sep, 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. 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1","display":"","copyAsset":false,"role":"figure","size":376836,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTrial flowchart\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7603307/v1/bc1ca3430d47729423c57e65.png"},{"id":93883323,"identity":"f8dad04e-9885-440f-b9a4-a9a2e2ee5691","added_by":"auto","created_at":"2025-10-19 17:01:05","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":63047,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTimeline and overview of enrolment, intervention, and assessments\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7603307/v1/fd77a42f294b8ed0e705c58d.png"},{"id":99545295,"identity":"890c52ab-2fb0-4c5c-9252-5ac4dddf2888","added_by":"auto","created_at":"2026-01-05 16:05:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1197112,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7603307/v1/c87b454a-911b-4f20-a417-88b75db98eb7.pdf"},{"id":93883324,"identity":"0f466d0f-2817-4cef-a220-e32fc69e4a68","added_by":"auto","created_at":"2025-10-19 17:01:05","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":1318378,"visible":true,"origin":"","legend":"","description":"","filename":"Sup.info14new.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7603307/v1/113f09a00fcaa2a9de938908.pdf"}],"financialInterests":"","formattedTitle":"Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: Young shoulder CARE (displaCed proximAl humerRus fractueE) trial - a study protocol for a pragmatic randomized controlled trial","fulltext":[{"header":"Background","content":"\u003cp\u003eProximal humerus fractures (PHF) are common injuries with an incidence of 138 per 100,000 person-years in adults aged 18 years and above in Denmark, increasing with age and have remained stable over decades [1]. In Denmark (2018) the total annual number of PHF was 6,318 (72 % women) [1]. In Finland (2019), the incidence among individuals aged over 16 years was 105 per 100,000. The incidence was higher in females and increased with age, particularly among those aged 50 years and older. The total annual number in 2019 was 4,826 cases [2]. \u0026nbsp;Less than half of the fractures are minimally displaced [3, 4], with displaced fractures defined as at least one of Codman\u0026rsquo;s four anatomic segments being displaced by \u0026ge;1 cm or angulated \u0026ge;45\u0026deg; (as defined by Neer [5]).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMeta-analyses comparing surgical and non‑surgical treatments for PHF have been rated as having critically low methodological quality [6]. A Cochrane review reported high‐certainty evidence of no clinically important difference between surgical and non‐surgical treatment in patient‐reported shoulder function one and two years after injury [7]. Most included studies focus on older patients; however, a subgroup analysis (aged 16-65) from the ProFHER study [8] found no statistically significant differences in patient-reported shoulder function (Oxford Shoulder Score (OSS)) between surgical and non-surgical treatment at 6 months, one year and two years. There was a trend toward more rapid improvement among younger patients (\u0026lt; 65 years) in the non-surgical group compared to those in the surgical group.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study focuses on patients aged 50-65. Individuals in this age group often differ from older adults in terms of functional demands, work status, overall health, and rehabilitation expectations. PHF is uncommon in patients below the age of 50, whereas incidence increases markedly from this age and onward [1,2]. More than 80 % of the fractures occurred in patients above 50 years [6], in females [1,2,9] and results from low-energy trauma [3,9,10]. Stratification by sex reveals a female predominance from the age of 50 [1,2,6], which coincides with an increase in age-related decrease of bone mineral density [11,12]. The exact prevalence of osteoporosis in the general population is not precisely known, as detection often relies on bone mineral density measurements, which are not routinely performed. Reduced bone mineral density is a known risk factor for complications following osteosynthesis [13,14].\u003c/p\u003e\n\u003cp\u003eThe surgical treatment of choice for displaced PHF in adults 50-65 years is anatomical reduction followed by osteosynthesis if possible [15-17]. Surgical options include internal fixation with locking plates, intramedullary nails, or joint replacement with hemiarthroplasty, or reverse shoulder arthroplasty. Complication and\u0026nbsp;reoperation rates are high after surgery [18].\u003c/p\u003e\n\u003cp\u003eOrthopaedic surgeons may encounter challenges in making treatment decisions with patients in this specific age group, as existing randomized trials have predominantly focused on older individuals[19]. There is an intermediate age group of patients for whom it remains uncertain whether surgical intervention is superior to non-surgical management in terms of benefits and harms.\u003c/p\u003e\n\u003cp\u003eThe aim of this study is to assess whether osteosynthesis results in superior patient-reported shoulder function compared to non-surgical treatment, as measured by the Oxford Shoulder Score at 12 months, in patients aged 50 to 65 years with displaced proximal humerus fractures.\u003c/p\u003e"},{"header":"Methods: Patients, Intervention, and Outcomes","content":"\u003cp\u003eStudy design\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003eThe study is a two-center, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment following a displaced PHF in patients aged 50-65 years with a 1:1 allocation ratio.\u003c/p\u003e\n\u003cp\u003eThe protocol will follow the PREPARE trial guide [20] and the SPIRIT checklist [21]. The study will be reported according to the CONSORT NPT checklist [22]. \u0026nbsp;The statistical analysis plan (Supplementary information, file 1) will follow the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials [23]. All checklists are available in Supplementary Information, file 2.\u003c/p\u003e\n\u003cp\u003eThe trial flow and timeline for data collection are outlined in Figures 1 and 2.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eParticipants\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003ePatients will be recruited from the orthopaedic departments at Zealand University Hospital in Denmark and Tampere University Hospital in Finland.\u003c/p\u003e\n\u003cp\u003eThe following inclusion criteria will apply:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePatients aged between 50 and 65 years with a displaced proximal humerus fracture after a low-energy trauma.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePatients should be cognitively capable of answering the follow-up questionnaires.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe following exclusion criteria will apply:\u003c/p\u003e\n\u003cp\u003eCommunication:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThe patient does not understand written and spoken native language (Danish or Finnish)\u003c/li\u003e\n \u003cli\u003eInability to give informed consent\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eFracture criteria:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eFractures assessed to be non-reconstructable by the treating surgeon\u003c/li\u003e\n \u003cli\u003eIsolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface\u003c/li\u003e\n \u003cli\u003eLess than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks postinjury\u003c/li\u003e\n \u003cli\u003ePathological fractures or previous fractures in the same proximal humerus\u003c/li\u003e\n \u003cli\u003eConcomitant fractures, which could influence the outcome\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eOther criteria:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eParalysis of the upper extremity\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch2\u003eRecruitment\u003c/h2\u003e\n\u003cp\u003ePatients admitted to the emergency department will be clinically examined by the emergency doctor. Two perpendicular plain radiographs will be obtained. If a displaced PHF is diagnosed, the patient will be referred to the outpatient clinic within two weeks postinjury. Patients will be screened for eligibility based on the initial radiographs and medical records by the investigator at the clinic. During the first visit to the outpatient clinic, the patient will be informed about the study. Potential participants will receive verbal and written information about the study from the local investigator. If eligible and consenting to participate, the local investigator will provide face-to-face trial instructions, and informed consent will be obtained.\u003c/p\u003e\n\u003ch2\u003eNon-randomized cohort\u003c/h2\u003e\n\u003cp\u003eEligible patients who decline participation will be recorded; when possible, their reasons for declining will be noted. These patients will be invited to participate in the non-randomised cohort. The patient can choose surgery only if recommended by the surgeon; such cases will be reported. Patients in the non-randomized cohort who provide informed consent will participate in the same treatment, rehabilitation, follow-up and outcome assessments as the randomized cohort, with data recorded for research purposes.\u003c/p\u003e\n\u003ch2\u003eRandomization and concealment of allocation\u003c/h2\u003e\n\u003cp\u003eWe will use Research Electronic Data Capture (REDCap) [24] to generate an irreversible randomization sequence. A person not involved in the project will generate and upload the allocation table using \u0026apos;R\u0026apos;. All investigators will be blinded to the allocation table. The person not involved in the project will have no access, including no access to the data. We will be using block randomization, including location stratification (shifting block sizes of 4 and 6 in each block). REDCap will conceal the sequence for the investigators before allocation takes place. Enrolment and allocation will occur on-site by LH, AL, BS, or LK. A REDCap built-in functionality ensures that only patients who meet all inclusion and no exclusion criteria can be randomized.\u003c/p\u003e\n\u003ch2\u003eIntervention\u003c/h2\u003e\n\u003cp\u003eAll patients will receive standard pain management following local guidelines and will be provided with a sling and swathe on the day of the injury in the emergency room. After 10 to 14 days, all patients will undergo evaluation in the outpatient clinic.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eSurgical group\u003c/u\u003e: The surgical group will receive osteosynthesis with a locking plate or an intramedullary locking nail, according to the surgeon\u0026rsquo;s preference. The patients will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eNon-surgical group\u003c/u\u003e: Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1\u0026ndash;2 weeks at their first visit, 10-14 days post-injury. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments.\u0026nbsp;\u003cbr\u003eIf there is still severe pain at week 6, it is considered a treatment failure. Severe pain is defined as being unable to sleep due to pain and/or requiring opioids to manage it (without opioid use prior to injury). If there is little progress but moderate pain, an additional consultation can be provided 12 weeks post-injury with clinical and radiological follow-up.\u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eBoth groups\u003c/u\u003e: Patients will be offered standard 6-month radiographs and clinical assessments, as well as a diagnostic workup for osteoporosis with a DXA scan. Osteopenia is defined as a T-score between -2.5 and -1. Osteoporosis is defined as a T-score lower than or equal to -2.5. [25] Additionally, osteoporosis can be diagnosed by hip and spine fractures, which, in Denmark, is considered pathognomonic for osteoporosis\u003c/p\u003e\n\u003cp\u003eBoths groups will be referred to post-operative rehabilitation in the municipalities. (Supplementary information, file 3 \u0026ndash; Rehabilitation). The rehabilitation program is similar, starting post-surgery for the surgical group and from the time of injury for the non-surgical group. The duration, intensity, and exercises used will be tailored in collaboration between the patients and the physiotherapist. Rehabilitation typically lasts 6-12 weeks. Adherence to rehabilitation is defined as completing at least 6 weeks of rehabilitation and following rehabilitation protocol.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eTreatment failure:\u0026nbsp;\u003c/u\u003eIn case of treatment failure in either group, defined as persistent pain or a failed osteosynthesis, a salvage procedure with secondary osteosynthesis, including the possibility to use a locking plate with a graft or a reverse shoulder arthroplasty (RSA), will be offered. Failed osteosynthesis and the most appropriate salvage procedure will be defined by the surgeon.\u003c/p\u003e\n\u003cp\u003eCross-over to reverse shoulder arthroplasty or revision osteosynthesis is considered a failure of treatment regardless of group allocation. The patient will remain in the study. The reason for crossing over will be noted and reported.\u003c/p\u003e\n\u003cp\u003eStrategies to improve retention\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003ePatients will receive a phone number to contact the local investigator with any questions. All included patients will be seen by either LH, SB, AL, BS, or LK at all appointments. Follow-up is planned at 6, 12, and 24 months. The 6-month follow-up includes radiographs, clinical assessment (range of motion, strength, and test for subacromial pain), and questionnaires. Data will be stored using Research Electronic Data Capture (REDCap) [24]. At the 12 and 24-month follow-ups, questionnaires will be automatically sent by REDCap for patients to complete from home, provided the patient has a mailing address. Patients are asked to accept telephone calls if they miss follow-up visits to promote patient retention and complete follow-up. Reminders will be sent 2 and 4 weeks after receiving their 12 and 24-month questionnaires. After 6 weeks, completion by phone will be offered if still unanswered [26].\u003c/p\u003e\n\u003ch2\u003eOutcome\u003c/h2\u003e\n\u003cp\u003eThe primary outcome will be the OSS at 12-months. The secondary outcome will be OSS at 6- and 24- month and EQ-5D-3L score measured at the 6-, 12- and 24 months. Secondary outcomes will include the incidence of adverse events in all groups and the rate of conversion to surgery in nonoperative group.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOxford Shoulder Score (OSS)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOSS is a patient-reported shoulder-specific outcome measure to assess shoulder function. It consists of 12 questions on a 5-point Likert scale (both pain- and function-related), each offering five ordinal response options. The cumulative score ranges between 0 and 48, being 0 (worst) to 48 (best: no pain or functional limitation). The questionnaire includes a mix of functional ability and pain-related questions. It is validated in adults with shoulder pain from a degenerative or inflammatory condition (median age 57.4 in UK) [27], and in Denmark in patients with post-traumatic shoulder diseases, including impingement and sequelae after PHF [28]. Patients in follow-up cohorts does not need to attend the clinic in person to complete the OSS [28].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuality of life (EQ-5D-3L)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEQ-5D-3L is a generic health-related quality-of-life assessment tool validated as a quality of life measure in patients with PHF [29]. It consists of a 5-dimension descriptive questionnaire about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as a measure for health-related quality of life [30]. Each dimension has 3 levels: No problems, some/moderate problems, and unable/extreme problems. Each dimension is weighted differently and results in a total score based on the EQ-5D index calculator (TTO). The EQ-5D-3L also includes an overall scale (numeric rating scale) in which patient rates their overall health condition today on a scale between 1 - 100, with 100 being the highest level of health imaginable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse events:\u0026nbsp;\u003c/strong\u003e\u003cu\u003e\u003cbr\u003e\u003c/u\u003eSerious adverse events, as defined by the WHO [31], will be reported to a data monitoring committee (DMC). These events are defined as those leading to death, being life-threatening, requiring inpatient hospitalization, or necessitating reoperation.\u003cbr\u003eOther adverse events, whether surgical or non-surgical related, will also be reported.\u003c/p\u003e\n\u003cp\u003eSystematic reviews on terms and definitions for complications after surgical [32] and non-surgical treatment [33] have been conducted. Based on international consensus on the core event set for PHF, both surgical and non-surgical treatments, eight event groups are defined [34]. The following adverse event groups will be monitored: implant, osteochondral, shoulder instability, peripheral neurology, vascular, infection, device, superficial soft tissue, and deep soft tissue. In addition to this, we have chosen to monitor clinical symptoms such as persistent severe pain. The event groups are elucidated in Supplementary information, file 4 \u0026ndash; Complications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConversion to surgery:\u003c/strong\u003e The criteria for conversion to surgery are based on an overall clinical evaluation conducted in collaboration with the patient. In the non-surgical group, the primary reason for conversion is persistent severe pain after 6-12 weeks. In the surgery group, adverse events can serve as reasons for conversion to RSA. Patients who discontinue for reasons unrelated to surgery will be documented and recorded. Patients receiving osteosynthesis or RSA will also have follow-up assessments after 6, 12, and 24 months.\u003c/p\u003e\n\u003ch2\u003eStatistical methods\u0026nbsp;\u003c/h2\u003e\n\u003ch2\u003eHypothesis\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eThe null hypothesis is that the shoulder function measured with OSS 12 months after surgery is not superior to non-surgical treatment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe alternative hypothesis is that the shoulder function measured with OSS 12 months after surgery is superior to non-surgical treatment.\u003c/p\u003e\n\u003ch2\u003eSample size and power considerations\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eThe standard deviation (SD) has been reported as 12 for OSS [35]. The Minimal Clinically Important Difference (MCID) for the OSS (0-48) is in the range of 5\u0026ndash;6.9 in various shoulder diseases, age groups, and assessment points \u0026ndash; but has not been established for PHF [35-\u0026gt;36]. Without a patient-derived MCID for PHF, a relevant difference of 9,6 was assumed to represent a clinically meaningful difference. This corresponds to approximately a 20% difference between the surgical group and the non-surgical group on a 0\u0026ndash;48 OSS scale. With a power of 80% and a 5% level of significance, a sample size of 25 patients per group is required. Assuming a 15% loss to follow-up, the recruitment target is 30 patients in each group, resulting in a total of 60 patients. The recruitment period is expected to be 24 months.\u003c/p\u003e\n\u003ch2\u003eStatistical analysis\u003c/h2\u003e\n\u003cp\u003eThe statistical analysis plan is available within Supplementary Information, file 1.\u003c/p\u003e\n\u003cp\u003eBaseline characteristics will be presented using descriptive statistics. We will compare the following patient characteristics between the groups at baseline: age (categorized into 5-year age groups), sex, height, weight, ASA score, fracture classification (Neer [5]), dominant arm (yes/no), smoking, alcohol consumption, educational level, working status, work type, osteoporosis (three-level ordinal variable based on T-scores (osteoporosis, osteopenia, and normal bone density)) and clinical frailty scale [37]. SD will be reported, and n (%) for categorical values.\u003c/p\u003e\n\u003cp\u003eOsteoporosis will be collected and reported descriptively as a three-level ordinal variable based on T-scores (osteoporosis, osteopenia, and normal bone density).\u003c/p\u003e\n\u003cp\u003eThe OSS results for surgical and non-surgical treatment groups at 6, 12, and 24 months will be tabulated and graphically represented with mean, SD, median, and IQR according to the distribution.\u003c/p\u003e\n\u003cp\u003eThe primary outcome, OSS at 12 months, will be analysed using two-sample t-test comparing the two treatment groups. Normality assumptions will be assessed, and if violated, alternative methods such as transformation or non-parametric Mann\u0026ndash;Whitney U test will be considered. As suggested in the extension of the CONSORT 2010 statement, the primary outcome will be analysed for the intention-to-treat (ITT) population.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition, linear mixed models will be used to analyse OSS and EQ-5D over time (6, 12 and 24 months) accounting for the repeated measures structure and to explore outcome trajectories. Model-based contrasts from the LMM will be used to estimate adjusted between-group differences at specific time points. Missing data will be handled within the mixed model framework, assuming data are missing at random. Details are provided in Supplementary Information, file 4. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe will record and report adverse events in each group. At the 6-month follow-up, patients will be asked, and we will record and report\u0026nbsp;the length of rehabilitation in municipalities (in weeks) and whether the patient has followed the rehabilitation plan.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSalvage procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSalvage procedures and adverse events will be reported descriptively. Reoperation in the form of hardware removal will be classified as a complication, not a salvage procedure. There will be two analyses for ITT: one including salvage procedures and one excluding them. The timing of salvage procedures will be analyzed using a Cox proportional hazards model to compare time to salvage between treatment groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNon-randomized cohort\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients who declined randomization but consented to follow-up will form the non-randomized cohort. Baseline characteristics will be summarized descriptively and compared between the randomized and non-randomized cohorts, as well as among the non-randomized patients by treatment choice. The primary outcome (OSS at 12 months) will be analyzed by treatment modality. Secondary outcome measures (OSS and EQ-5D) will be presented descriptively and graphically at 6, 12, and 24 months. Analyses will include multivariable linear regression adjusted for baseline covariates; propensity score methods may be applied. The incidence and timing of salvage procedures will be described and analyzed using Cox proportional hazards models.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBlinded data interpretation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAlthough patients and investigators are not blinded to treatment allocation, the primary investigator will conduct blinded statistical analysis through data anonymization and will be supervised by a biostatistician. The OSS and EQ-5D-3L will be completed just before the 6-month visit, collected automatically through REDCap, and will not be reviewed by the investigator prior to analysis- After the blinded statistical analysis has been completed, two abstracts will be written based on the pre-blinding analysis results before the blinding is revealed.\u003c/p\u003e\n\u003cp\u003eData will be analysed using the statistical \u0026ldquo;R\u0026rdquo; [38].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterim analyses\u003cbr\u003e\u003c/strong\u003eAn interim analysis will be conducted when 50% (n = 30) of the randomized patients have completed their 6-month follow-up, focusing on OSS, failure to treatment, and serious complications. A third party will blind the data to treatment location before analysis. Regardless of whether the interim analyses suggest that the study is unlikely to achieve its primary objectives, the study will proceed as initially planned.\u003cu\u003e\u0026nbsp;\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eA DMC has been organized to monitor and evaluate the data from the interim analysis. The DMC consists of four independent members, including four orthopedic researchers and an orthopedic nurse.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe DMC will monitor unexpected, unwanted events; continued inclusion will be considered if the failure rate is above 30 %. Intervention-related hospitalization or mortality will be reported to the ethics committee.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eData management\u003c/h2\u003e\n\u003cp\u003eAll study data will be collected and stored in Research Electronic Data Capture (REDCap) [24]. Clinical assessments and radiographs will be entered directly into REDCap by the investigators (LH, SB, AL, BS, or LK). Questionnaires at 12 and 24 months will be distributed electronically through REDCap. Data will be stored securely on institutional servers with access restricted to study personnel.\u003c/p\u003e\n\u003ch2\u003eProtocol violation\u003c/h2\u003e\n\u003cp\u003ePatients who drop out of the trial will be noted, along with the reasons. The patients will remain in the study and be included in the ITT analysis. Numbers and time for loss to follow up will be reported.\u003c/p\u003e\n\u003ch2\u003ePatient and public involvement\u003c/h2\u003e\n\u003cp\u003eFour patients read and commented on the written information sheet, confirming the understandability and that it was sufficiently informative.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eRelevance of Age in Existing Evidence\u003c/h2\u003e\u003cp\u003eCurrent high-quality evidence on proximal humerus fracture treatment primarily concerns patients from 60 or above. This leaves a knowledge gap in the younger, still working-age population aged 50\u0026ndash;65. A Cochrane review reported high- or moderate-certainty evidence that surgery, compared to non-surgical treatment after a displaced proximal humerus fracture, did not provide a better outcome after one and two years [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, patients aged 50\u0026ndash;65 may differ in functional demands, health status, and recovery expectations. Despite this, they are typically underrepresented in clinical trials.\u003c/p\u003e\u003cp\u003eThe Young Shoulder CARE trial was designed to contribute to addressing this evidence gap. By focusing exclusively on patients aged 50\u0026ndash;65, the trial aims to generate age-specific data to inform clinical decision-making for this population better. The pragmatic design was chosen to reflect real-world clinical practice and increase external validity.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eDefining \u0026ldquo;older adults\u0026rdquo;\u003c/h2\u003e\u003cp\u003eThere is no universally agreed-upon age cut-off for what constitutes an \"older\" adult; yet age definitions are crucial in trial inclusion and generalizability. WHO previously characterized older people as those over 65 years (2010 report), the latest age report has no precise definition. The term \"older\" is too complex due to multiple factors and variations in global age distribution, making it challenging to establish an age cutoff [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. The Danish Health Authority [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e] and International Population Report of the National Institutes of Health [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e], defines \u0026ldquo;older\u0026rdquo; as individuals surpassing the age of 65. In orthopaedic research, Sabharwal found that age 65 is the most common age at which a person is considered \"older\u0026rdquo; [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eWe aimed to investigate a population that differs from older adults in terms of functional demands, general health status, and expectations for recovery. To ensure the inclusion of individuals who are still active in the workforce, we focused on patients below the typical retirement age. In Finland and Denmark, the retirement age is 65\u0026ndash;67 years [43, 44]. Consequently, we selected 65 years as the upper age limit to target a relatively younger and more active patient group. This allows our trial to clearly complement and extend existing evidence focused on older adults.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eMCID\u003c/h2\u003e\u003cp\u003eA MCID for the OSS in patients with PHF has not been established. MCID for the OSS (0\u0026ndash;48) is 5\u0026ndash;6.9 in various shoulder conditions [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. However, the concept of MCID is inherently context-dependent and may vary according to patient characteristics such as age, sex, baseline function, injury mechanism, comorbidities - and may also change over time [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. As such, the MCID should not be regarded as a fixed value. In the absence of a MCID specific for the population, we defined a difference of 9.6 points on the OSS\u0026mdash;equivalent to 20% of the scale\u0026mdash;as clinically meaningful for this trial. This threshold was used for the sample size calculation, reflecting the view that surgical treatment should yield a substantial benefit to be considered appropriate. Future research should aim to validate or refine the MCID specific to PHFs.\u003c/p\u003e\u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eASA\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eAmerican Society of Anesthesiologists Score\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eDXA\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eDual-Energy X-ray Absorptiometry Scan\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eEQ-5D-3L\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eEuropean Quality of Life \u0026ndash; 5 dimensions \u0026ndash; 3 levels\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eITT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eIntention to treat\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eMCID\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMinimal Clinically Important Difference\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eOSS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eOxford Should Score\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePHF\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eProximal humerus fracture\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePROM\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePatient-reported outcome measure\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eRandomized controlled trial\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eREDCap\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eResearch Electronic Data Capture\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eStandard deviations\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSPIRIT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eThe Standard Protocol Items:Recommendations for Interventional Trials\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eWHO\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eWorld Health Organization\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003ePermissions\u003c/h2\u003e\n\u003cp\u003eWe have obtained permission to use Clinical Frailty Scale (ID: 20240125-13). We have obtained permission to use the Danish, Swedish and Finish version of Oxford Shoulder Score (00OSS-1643060) and the Danish, Swedish and Finish version of EQ-5D (Registration ID: 60840).\u003c/p\u003e\n\u003ch2\u003eEthical approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThe study will adhere to the ethical principles outlined in the Declaration of Helsinki. Participants will provide written, informed consent. Approval has been granted by the scientific ethics committees in Denmark (EMN-2024-01516) and Finland (ETL R24048) (Supplementary information, file 5).\u003c/p\u003e\n\u003cp\u003eThe Data Protection Agency has approved the handling of personal data (p-2024-16591). Any significant changes to the trial will be reported to the National Committee on Health Research Ethics in each country and registered on ClinicalTrials.gov.\u003c/p\u003e\n\u003cp\u003eSubstantial protocol modifications will be approved by the relevant ethics committee before implementation and communicated to investigators, the trial registry, and other relevant parties as appropriate.\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eData sharing not applicable to this article as no datasets were generated or analysed during the current study.\u003c/p\u003e\n\u003cp\u003eThe Data Protection Agency of Region Zealand has approved the handling of personal data (p-2024-16591). Compliance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act will be ensured at all times. A data processing agreement has been signed in both recruiting centers.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResearch data is stored on REDCap, a secure online patient management program, accessible only to LH, SB, AL, BS, and L.K. on a secure server at Region Zealand University Hospital (with two-factor authentication login. The primary investigator will have access to the final data set. The REDCap setup ensures that randomization is only possible, if all baseline information is entered correctly.\u0026nbsp;All data will be fully anonymized before publication.\u003c/p\u003e\n\u003cp\u003eThe trial results will be published in an open-access peer-reviewed journal.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThe trial is conducted as part of a PhD project, with tuition fees to the University of Copenhagen funded by the regional research fund Region Zealand Health Science Research Foundation [Region Sj\u0026aelig;llands Sundhedsvidenskabelige Forskningsfond]. The principal investigator (LH) is employed by the Department of Orthopedic Surgery, Zealand University Hospital, K\u0026oslash;ge, and is guaranteed a salary from the department throughout the PhD-period. The study has received partial funding from Region Zealand Health Science Research Foundation [Region Sj\u0026aelig;llands Sundhedsvidenskabelige Forskningsfond] (ref. R41‐A1846), Lippmann Fonden, and Spies Fonden (For grants and salary guarantee, see Supplementary information, file 6). Current and future funders have no role in the design, conduct, analysis, interpretation of data, or decision to submit results for publication. No commercial or industrial funding is involved. Both surgical and non-surgical devices are part of standard care and will be provided by the participating trial sites.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eAuthors contributions\u003c/h2\u003e\n\u003cp\u003eThe LH has initiated and designed the study in collaboration with SB. and AL. LH drafted the study protocol and BS, LK, ZI and KH contributed to the protocol refinement and approved the final version. LH, SB and AL\u0026nbsp;will ensure the execution and completion of the project. LH and SB is recruiting in K\u0026oslash;ge, Denmark. AL, BS and LK is recruiting in Tampere, Finland. LH is the grant holder and takes overall responsibility for participant inclusion and data collection. LH will draft the manuscripts for study result publication with contributions and approval of final versions from AL, BS, LK, ZI, KH and SB.\u003c/p\u003e\n\u003ch2\u003eAcknowledgement\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eWe would like to thank Sahar Moeini for generation and upload of allocation table. The authors would like to thank Maria D. Nielsen, Janika Pietila, Marketta Rautanen for administrative support.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe would like to thank Dennis Winge Hallager, Dennis Karimi, Birgitte Bonkegaard, Aleksi Reito and Ville Mattila for being part of the DMC.\u003cbr\u003e\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBrorson, S., Viberg, B., Gundtoft, P., Jalal, B., \u0026amp; Ohrt-Nissen, S. (2022). Epidemiology and trends in management of acute proximal humeral fractures in adults: an observational study of 137,436 cases from the Danish National Patient Register, 1996\u0026ndash;2018. Acta Orthopaedica, 93, 750\u0026ndash;755. https://doi.org/10.2340/17453674.2022.4578\u003c/li\u003e\n\u003cli\u003eLeino OK, Lehtim\u0026auml;ki KK, M\u0026auml;kel\u0026auml; K, \u0026Auml;\u0026auml;rimaa V, Ekman E. Proximal humeral fractures in Finland: trends in the incidence and methods of treatment between 1997 and 2019. Bone Joint J. 2022;104-B(1):150-156. doi:10.1302/0301-620X.104B1.BJJ-2021-0987.R1\u003c/li\u003e\n\u003cli\u003eCourt-Brown C M, Garg A, McQueen M M. The epidemiology of proximal humeral fractures. Acta Orthop Scand 2001; 72: 365-71. doi: 10.1302/0301-620x.83b6.11401. \u003c/li\u003e\n\u003cli\u003eBrorson S. How many shoulder fractures are displaced? How a misleading statement became orthopedic knowledge. Acta Orthop. 2023;94:328-329. Published 2023 Jul 4. doi:10.2340/17453674.2023.13651\u003c/li\u003e\n\u003cli\u003eNeer CS: Displaced proximal humeral fractures. Classification and evaluation. J Bone Joint Surg Am. 1970, 52 (6): 1077-1089.\u003c/li\u003e\n\u003cli\u003eSandau, N., Buxbom, P., Hr\u0026oacute;bjartsson, A., Harris, I. A., \u0026amp; Brorson, S. (2022). The methodological quality was low and conclusions discordant for meta-analyses comparing proximal humerus fracture treatments: a meta-epidemiological study. \u003cem\u003eJournal of clinical epidemiology\u003c/em\u003e, \u003cem\u003e142\u003c/em\u003e, 100\u0026ndash;109. https://doi.org/10.1016/j.jclinepi.2021.10.014. \u003c/li\u003e\n\u003cli\u003eHandoll HHG, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews 2022, Issue 6. Art. No.: CD000434. DOI: 10.1002/14651858.CD000434.pub5.\u003c/li\u003e\n\u003cli\u003eHandoll H, Brealey S, Rangan A, Keding A, Corbacho B, Jefferson L, Chuang LH, Goodchild L, Hewitt C, Torgerson D. The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults. Health Technol Assess. 2015 Mar;19(24):1-280. doi: 10.3310/hta19240\u003c/li\u003e\n\u003cli\u003eBergdahl C, Ekholm C, Wennergren D, Nilsson F, M\u0026ouml;ller M. Epidemiology and patho-anatomical pattern of 2,011 humeral fractures: data from the Swedish Fracture Register. BMC Musculoskelet Disord. 2016;17:159. Published 2016 Apr 12. doi:10.1186/s12891-016-1009-\u003c/li\u003e\n\u003cli\u003eLind, T., Kr\u0026oslash;ner, K., \u0026amp; Jensen, J. (1989). The epidemiology of fractures of the proximal humerus. Archives of orthopaedic and trauma surgery, 108(5), 285\u0026ndash;287. https://doi.org/10.1007/BF00932316 \u003c/li\u003e\n\u003cli\u003eJohnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int 2005; 16(Suppl. 2): S3-7. doi: 10.1007/s00198-004-1702-6\u003c/li\u003e\n\u003cli\u003eSarafrazi N., Wambogo E., Shephard J. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017\u0026ndash;2018 NCHC Data Brief, no 406, march 2021 \u003c/li\u003e\n\u003cli\u003eSpross C, Zeledon R, Zdravkovic V, Jost B. How bone quality may influence intraoperative and early postoperative problems after angular stable open reduction-internal fixation of proximal humeral fractures. J Shoulder Elbow Surg. 2017 Sep;26(9):1566-1572. doi: 10.1016/j.jse.2017.02.026\u003c/li\u003e\n\u003cli\u003eMin KS, Sheridan B, Waryasz GR, Joeris A, Warner JJP, Ring D, Chen N. Predicting reoperation after operative treatment of proximal humerus fractures. Eur J Orthop Surg Traumatol. 2021 Aug;31(6):1105-1112. doi: 10.1007/s00590-020-02841-w\u003c/li\u003e\n\u003cli\u003eBuckley, R, Moran CG, Apivatthakakul AO principles of fractures. 2nd edition. Thieme. ISBN: 9781588905567, p. 575-+585 + 590\u003c/li\u003e\n\u003cli\u003eRockwood Jr et al. Rockwood and Matsen\u0026rsquo;s The Shoulder. 5th edition. Elsevier. ISBN: 0323297315 P. 199-201\u003c/li\u003e\n\u003cli\u003eWilliams AA et al. Consensus statement on the treatment of proximal humerus fractures: a Delphi approach by the Neer Circle of the American Shoulder and Elbow Surgeons. J Shoulder Elbow Surg. 2025 Jan 22:S1058-2746(25)00065-5. doi: 10.1016/j.jse.2024.12.005\u003c/li\u003e\n\u003cli\u003eOldrini LM, Feltri P, Albanese J, Marbach F, Filardo G, Candrian C. PHILOS Synthesis for Proximal Humerus Fractures Has High Complications and Reintervention Rates: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Feb 19;12(2):311. doi: 10.3390/life12020311.\u003c/li\u003e\n\u003cli\u003eLee G, Hasegawa I, Obana K, Min KS. Analyzing outcomes after proximal humerus fractures in patients \u0026lt;65 years: a systematic review and meta-analysis. JSES Rev Rep Tech. 2021 May 21;1(3):165-170. doi: 10.1016/j.xrrt.2021.04.014. \u003c/li\u003e\n\u003cli\u003eBandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. \u003c/li\u003e\n\u003cli\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hr\u0026oacute;bjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586\u003c/li\u003e\n\u003cli\u003eBoutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40-47.\u003c/li\u003e\n\u003cli\u003eGamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dor\u0026eacute; C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017;318(23):2337-2343\u003c/li\u003e\n\u003cli\u003eHarris PA, Ph D, Taylor R, Thielke R, Ph D, Payne J, et al. Research Electronic Data Capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. 2010;42(2):377\u0026ndash;381\u003c/li\u003e\n\u003cli\u003eKanis JA on behalf of the World Health Organization Scientific Group. Assessment of osteoporosis at the primary health-care level. https://www.sheffield.ac.uk/FRAX/pdfs/WHO_Technical_Report.pdf (date last accessed 15 August 2024). \u003c/li\u003e\n\u003cli\u003eNakash RA, Hutton JL, J\u0026oslash;rstad-Stein EC, Gates S, Lamb SE. Maximising response to postal questionnaires--a systematic review of randomised trials in health research. BMC Med Res Methodol. 2006;6:5. Published 2006 Feb 23. doi:10.1186/1471-2288-6-5\u003c/li\u003e\n\u003cli\u003eDawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br 1996;78:593-600\u003c/li\u003e\n\u003cli\u003eFrich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011;58(11):A4335. visited 13-09-23\u003c/li\u003e\n\u003cli\u003eOlerud P, Tidermark J, Ponzer S, Ahrengart L, Bergstr\u0026ouml;m G. Responsiveness of the EQ-5D in patients with proximal humeral fractures. J Shoulder Elbow Surg. 2011 Dec;20(8):1200-6. doi: 10.1016/j.jse.2011.06.010. Epub 2011 Oct 20. PMID: 22014617.\u003c/li\u003e\n\u003cli\u003eEQ-5D-3L: https://euroqol.org/eq-5d-instruments/eq-5d-3l-about/ (visited 03-07-2025)\u003c/li\u003e\n\u003cli\u003eWHO: E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (europa.eu), visited 13-09-23\u003c/li\u003e\n\u003cli\u003eAlispahic, N., Brorson, S., Bahrs, C. et al. Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions. BMC Musculoskelet Disord 21, 327 (2020). https://doi.org/10.1186/s12891-020-03353-8\u003c/li\u003e\n\u003cli\u003eBrorson S, Alispahic N, Bahrs C, et al. Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions. BMC Musculoskelet Disord. 2019 Feb 23;20(1):91. doi: 10.1186/s12891-019-2459-6.\u003c/li\u003e\n\u003cli\u003eAudig\u0026eacute;, L., Brorson, S., Durchholz, H. et al. Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process. BMC Musculoskelet Disord 22, 1002 (2021). https://doi.org/10.1186/s12891-021-04887-1\u003c/li\u003e\n\u003cli\u003eBaker P, Nanda R, Goodchild L, Finn P, Rangan A. A comparison of the Constant and Oxford Shoulder Scores in patients with conservatively treated proximal humeral fractures.J Shoulder Elbow Surg. 2008;17(1):37-41\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\u0026ndash;92. 10.1016/j.jse.2019.12.033\u003c/li\u003e\n\u003cli\u003eRockwood K, Theou O. Using the clinical frailty scale in allocating scarce health care 12 resources. Can Geriatr J. 20bpo20;23(3):254\u0026ndash;9\u003c/li\u003e\n\u003cli\u003eR Core Team (2021). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/ \u003c/li\u003e\n\u003cli\u003eAgeing and Health, Demographic Change and Healthy Ageing, Social Determinants of Health by WHO 2015 https://www.who.int/publications/i/item/9789241565042 accessed 18.09.23\u003c/li\u003e\n\u003cli\u003e[https://www.sst.dk/-/media/Udgivelser/2019/%C3%86ldres-sundhed-og-trivsel.ashx 22-08-23] visited 03-07-2025\u003c/li\u003e\n\u003cli\u003eAn Aging World: 2015 (census.gov) visited 22-08-23\u003c/li\u003e\n\u003cli\u003eSabharwal S, Wilson H, Reilly P, Gupte CM. Heterogeneity of the definition of elderly age in current orthopaedic research. Springerplus. 2015 Sep 17;4:516. doi: 10.1186/s40064-015-1307-x. \u003c/li\u003e\n\u003cli\u003e[https://star.dk/ydelser/pension-og-efterloen/folkepension-tidlig-pension-foertidspension-og-seniorpension/folkepension/folkepensionsalderen-nu-og-fremover] visited 03-07-2025\u003c/li\u003e\n\u003cli\u003ehttps://www.tyoelake.fi/en/different-pensions/old-age-pension-your-retirement-age-is-based-on-your-year-of-birth/ visited 03-07-2025\u003c/li\u003e\n\u003cli\u003eWright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Man Manip Ther. 2012 Aug;20(3):160-6. doi: 10.1179/2042618612Y.0000000001\u003c/li\u003e\n\u003cli\u003eMcNally, Martin A. et al. \u0026ldquo;The EBJIS definition of periprosthetic joint infection. \u003cem\u003eThe Bone \u0026amp; Joint Journal\u003c/em\u003e 103-B (2021): 18 - 25.\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":"Shoulder fractures, Patient Reported Outcome Measures, middle aged, orthopaedic procedures, outcome assessment","lastPublishedDoi":"10.21203/rs.3.rs-7603307/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7603307/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eProximal humerus fractures (PHF) are common in adults above 50 years, often following low-energy trauma and underlying osteoporosis. Randomized trials in patients 60 years and older have found no clinically important difference in one- and two-year outcomes between surgical and non-surgical treatments. There is limited evidence for the 50–65 age group, who may have different functional demands and even a different overall health status. There is limited knowledge to guide treatment decisions for this age group.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethod:\u003c/strong\u003e A multicenter, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment in patients aged 50–65 years with displaced PHF. A total of 60 patients will be randomized equally to surgical treatment (primary osteosynthesis) or non-surgical treatment. Follow up visits are arranged at 6 weeks and 6 months for all patients, with an additional 12-week visit mandatory for the surgical group and optional for the non-surgical group.\u003cbr\u003e\nThe primary outcome is Oxford Shoulder Score at 12 months. In case of treatment failure (persistent pain or a failed osteosynthesis), a salvage procedure will be offered. Non-randomised cohort will have baseline data and preferences recorded, and they will receive the same follow-up and outcome assessments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e Young Shoulder CARE trial aims to provide insights into the treatment of displaced proximal humerus fractures in patients aged 50-65 years, and to understand the benefits and harms of both surgical and non-surgical treatment options. The trial results will be published in an open-access peer-reviewed journal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e Clinicaltrials.gov, NCT06416618, registered 14 May 2024.\u003c/p\u003e","manuscriptTitle":"Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: Young shoulder CARE (displaCed proximAl humerRus fractueE) trial - a study protocol for a pragmatic randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-19 16:53:01","doi":"10.21203/rs.3.rs-7603307/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-10-06T14:10:01+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-06T12:20:08+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-06T06:39:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-09-29T09:19:59+00:00","index":"","fulltext":""},{"type":"decision","content":"Minor revision","date":"2025-09-24T07:32:49+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":"544eae1e-3556-4300-9487-e222b99fe8d5","owner":[],"postedDate":"October 19th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-01-05T16:01:00+00:00","versionOfRecord":{"articleIdentity":"rs-7603307","link":"https://doi.org/10.1186/s13063-025-09283-x","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-12-29 15:57:54","publishedOnDateReadable":"December 29th, 2025"},"versionCreatedAt":"2025-10-19 16:53:01","video":"","vorDoi":"10.1186/s13063-025-09283-x","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09283-x","workflowStages":[]},"version":"v1","identity":"rs-7603307","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7603307","identity":"rs-7603307","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}