Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India

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Avascular Necrosis, a debilitating condition, necessitates exploration of interventions to mitigate progression. The trial is conducted at Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, focusing on clinical, radiographic, and patient-reported outcomes. Methods Skeletally mature participants diagnosed with stage 1 or 2 Avascular Necrosis of the femoral head will be randomly assigned to either Core Decompression with Bisphosphonate Therapy or Core Decompression Alone. Data collection from July 2022 to September 2024 will involve preoperative assessments, intraoperative details, postoperative care records, and followup evaluations at six weeks, three months, six months, and nine months. Statistical analyses will encompass primary outcomes assessed by Harris Hip Score, secondary outcomes including pain reduction and radiographic changes, and subgroup analyses. Expected Outcome Anticipated outcomes involve insights into the comparative effectiveness of the two interventions. Primary analyses will reveal variations in Harris Hip Score changes over time, while secondary analyses will shed light on pain reduction, radiographic changes, and potential complications. Subgroup analyses may discern nuances based on etiological factors. The results aim to inform clinical practice, guiding the optimal management of early Avascular Necrosis of the femoral head. 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F1000Research 2024, 13 :398 ( https://doi.org/10.12688/f1000research.146853.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India [version 1; peer review: 1 approved with reservations] Ashutosh Lohiya https://orcid.org/0009-0009-4842-1019 1 , Naresh Dhaniwala https://orcid.org/0000-0003-2640-4970 1 Ashutosh Lohiya https://orcid.org/0009-0009-4842-1019 1 , Naresh Dhaniwala https://orcid.org/0000-0003-2640-4970 1 PUBLISHED 26 Apr 2024 Author details Author details 1 Orthopedic, Datta Meghe Institute of Higher Education & Research, Wardha, 442001, India Ashutosh Lohiya Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Naresh Dhaniwala Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Background This study outlines a randomised control trial to assess the efficacy of Core Decompression with and without Bisphosphonate Therapy in managing early Avascular Necrosis of the femoral head. Avascular Necrosis, a debilitating condition, necessitates exploration of interventions to mitigate progression. The trial is conducted at Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, focusing on clinical, radiographic, and patient-reported outcomes. Methods Skeletally mature participants diagnosed with stage 1 or 2 Avascular Necrosis of the femoral head will be randomly assigned to either Core Decompression with Bisphosphonate Therapy or Core Decompression Alone. Data collection from July 2022 to September 2024 will involve preoperative assessments, intraoperative details, postoperative care records, and followup evaluations at six weeks, three months, six months, and nine months. Statistical analyses will encompass primary outcomes assessed by Harris Hip Score, secondary outcomes including pain reduction and radiographic changes, and subgroup analyses. Expected Outcome Anticipated outcomes involve insights into the comparative effectiveness of the two interventions. Primary analyses will reveal variations in Harris Hip Score changes over time, while secondary analyses will shed light on pain reduction, radiographic changes, and potential complications. Subgroup analyses may discern nuances based on etiological factors. The results aim to inform clinical practice, guiding the optimal management of early Avascular Necrosis of the femoral head. READ ALL READ LESS Keywords Avascular Necrosis, Femoral Head, Core Decompression, Bisphosphonate Therapy, Randomized Control Trial, Harris Hip Score, Radiographic Changes, Clinical Outcomes, Skeletal Maturity, Orthopedics. Corresponding Author(s) Ashutosh Lohiya ( [email protected] ) Close Corresponding author: Ashutosh Lohiya Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Lohiya A and Dhaniwala N. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Lohiya A and Dhaniwala N. Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :398 ( https://doi.org/10.12688/f1000research.146853.1 ) First published: 26 Apr 2024, 13 :398 ( https://doi.org/10.12688/f1000research.146853.1 ) Latest published: 26 Apr 2024, 13 :398 ( https://doi.org/10.12688/f1000research.146853.1 ) Introduction Avascular Necrosis of the femoral head (AVNFH) is a debilitating condition characterised by the disruption of blood supply to the femoral head, leading to ischemic necrosis and subsequent structural damage. It commonly affects individuals in the prime of their lives, resulting in pain, functional impairment, and, if left untreated, progression to hip joint degeneration. The aetiology of AVNFH is diverse, encompassing traumatic injuries, corticosteroid use, and systemic diseases such as sickle cell anaemia and systemic lupus erythematosus. 1 Core decompression has emerged as a promising surgical intervention for early-stage AVNFH, aiming to alleviate pain and halt disease progression by reducing intraosseous pressure and promoting revascularisation. Despite its potential benefits, the variable success rates reported in the literature underscore the need for further investigation into adjuvant therapies to optimise outcomes. Bisphosphonates, known for their anti-resorptive properties and positive effects on bone metabolism, have shown promise as an adjunctive treatment in AVNFH. 2 Alendronate, a bisphosphonate, has demonstrated its efficacy in improving bone density and reducing the risk of fractures in osteoporosis. 3 However, the role of bisphosphonate therapy in conjunction with core decompression for AVNFH management remains an active research area. This proposed randomised control trial seeks to contribute to the existing body of knowledge by rigorously evaluating the combined use of core decompression and bisphosphonate therapy to manage early AVNFH. Drawing on the foundational work of Steinberg and colleagues, 4 who highlighted the importance of early intervention and the potential benefits of bisphosphonates, this study aims to provide valuable insights into the comparative effectiveness of these treatment modalities. By elucidating the optimal approach to early AVNFH management, this research can enhance clinical decision-making and improve patient outcomes in a population susceptible to significant morbidity. The study’s foundation rests on the compelling need to address the challenges posed by AVNFH, emphasising the potential impact of a tailored, multidisciplinary treatment approach. Aim To evaluate the efficacy and safety of Core Decompression in managing early Avascular Necrosis of the femoral head, comparing outcomes with or without adjuvant bisphosphonate therapy. Primary objective To determine the impact of Core Decompression with bisphosphonate therapy compared to Core Decompression alone on the overall functional outcomes in patients with early-stage Avascular Necrosis of the femoral head, as measured by changes in the Harris Hip Score. Secondary objectives 1. To assess and compare the reduction in pain levels between the two treatment groups using the Visual Analogue Scale (VAS). 2. To evaluate and compare the radiographic changes in the femoral head in patients undergoing Core Decompression with bisphosphonate therapy versus Core Decompression alone. 3. To analyze and compare the incidence of complications and adverse events between the two treatment groups. Methods Study setting The study will be conducted at Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, in the Department of Orthopedics. The study will follow a prospective interventional design, with data collection from July 2022 to July 2024 and data analysis scheduled for August 2024 to September 2024. Inclusion criteria 1. Skeletally Mature Patients: Adults who have reached skeletal maturity will be eligible for inclusion. 2. Avascular Necrosis of Femoral Head (AVNFH): Patients diagnosed with Avascular Necrosis of the femoral head in stage 1 and stage 2, irrespective of the aetiology. 3. Willingness to Undergo Surgery: Patients willing to undergo surgical intervention for inclusion in one or both hips. Exclusion criteria 1. Previously Operated Hips: Patients with previous hip surgeries will be excluded. 2. Arthritic Changes in Involved Hip: Cases presenting with arthritic changes in the involved hip joint will be excluded. 3. Unwillingness for Surgery: Patients unwilling to undergo the prescribed surgical intervention. Interventions Patients meeting the inclusion criteria will be randomised into two groups: Group 1: Core Decompression with Bisphosphonate Therapy Patients in this group will undergo core decompression surgery combined with bisphosphonate therapy. Core Decompression Procedure 1. Preoperative Antibiotic Prophylaxis: Ceftriaxone antibiotic for 24 hours (3 doses) post-surgery to prevent infection. 2. Analgesic Regimen: Analgesics will be prescribed for five days postoperatively to manage pain. 3. Calcium and Vitamin Supplementation: Calcium and vitamin supplements will be provided for one-month post-surgery to support bone healing. 4. Bisphosphonate Therapy: Alendronate (70 mg) will be administered once weekly for nine months for odd-numbered participants in this group. Group 2: Core Decompression Alone Patients in this group will undergo core decompression surgery without bisphosphonate therapy. Core Decompression Procedure 1. Preoperative Antibiotic Prophylaxis: Similar to Group 1, ceftriaxone antibiotic for 24 hours (3 doses) post-surgery. 2. Analgesic Regimen: Similar to Group 1, analgesics will be prescribed five days postoperatively. 3. Calcium and Vitamin Supplementation: Similar to Group 1, calcium and vitamin supplements will be provided for one-month post-surgery. Outcomes Primary outcome The study’s primary outcome is the comparison of overall functional outcomes between the two intervention groups, as measured by changes in the Harris Hip Score 5 at the defined followup time points (6 weeks, three months, six months, and nine months). The Harris Hip Score assesses pain, function, absence of deformity, and range of motion, providing a comprehensive evaluation of hip joint health. Secondary outcomes 1. Pain Reduction (Visual Analogue Scale - VAS) 6 : Comparison of pain levels between the two groups using the Visual Analogue Scale at each followup visit. This assessment will provide insights into the immediate and sustained pain relief the interventions achieve. 2. Radiographic Changes in Femoral Head: Evaluation of radiographic changes in the femoral head using X-ray and MRI at each followup visit. This will include assessing structural changes, necrotic areas, and the progression or resolution of Avascular Necrosis. 3. Complications and Adverse Events: Monitoring and comparison of the incidence of complications and adverse events in both intervention groups. This will include surgical complications, bisphosphonate-related side effects, and any unexpected events affecting patient outcomes. Sample size calculation This means 29 or more measurements/surveys are needed to have a confidence level of 95% that the real value is within ±5% of the measured/surveyed value. Prevalence of AVN taken. 7 Recruitment 1. Identification of Potential Participants: Patients presenting with hip pain at the Department of Orthopedics, Jawaharlal Nehru Medical College, and Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, will be screened for potential inclusion. 2. Clinical Evaluation: Patients with suspected Avascular Necrosis of the femoral head will undergo a thorough clinical evaluation, including history, physical examination, and relevant investigations. 3. Radiological Assessment: Radiological assessments, including X-ray and MRI, will be performed to confirm the diagnosis and stage of the Avascular Necrosis. Only patients in stage 1 and stage 2 will be considered for inclusion. 4. Informed Consent: Eligible patients will be provided detailed information about the study, its objectives, interventions, and potential risks and benefits. Informed consent will be obtained from those willing to participate. 5. Randomization: Randomization will be conducted using a simple randomisation method to allocate participants into either the Core Decompression with Bisphosphonate Therapy or the Core Decompression Alone group. 6. Baseline Assessments: Baseline assessments, including demographic details, medical history, and baseline clinical and radiological data, will be collected from enrolled participants. 7. Surgical Intervention: Participants will undergo the assigned surgical intervention according to the randomisation. Core decompression with or without bisphosphonate therapy will be performed based on the allocated group. 8. Postoperative Care: Participants will receive postoperative care according to the defined protocol, including antibiotic prophylaxis, analgesics, and supplementary medications. 9. Follow-up Visits: Participants will be scheduled for followup visits at six weeks, three months, six months, and nine months postoperatively for clinical and radiological assessments. 10. Data Collection: Clinical, radiological, and laboratory data will be collected at each followup visit to assess the predefined outcomes. Allocation The allocation of participants into the two intervention groups, Core Decompression with Bisphosphonate Therapy and Core Decompression Alone, will be performed using a simple randomisation method. Randomisation aims to minimise selection bias and ensure that each participant has an equal chance of being assigned to either group, thus promoting the validity of the study results. Blinding Given the nature of the interventions, it may be challenging to blind the participants and the surgical team to the assigned treatment. However, efforts will be made to minimise bias in the assessment of outcomes through the following strategies: 1. Blinding of Outcome Assessors: Individuals responsible for collecting and assessing primary and secondary outcome measures, such as Harris Hip Score, Visual Analogue Scale, and radiographic evaluations, will be blinded to the treatment allocation. This blinding will help minimise potential bias in outcome assessments. 2. Data Analysis Blinding: Data analysis will be conducted by individuals who must be aware of the treatment allocation. Coding or labelling of treatment groups will be used to blind the statisticians involved in data analysis. 3. Blinding of Participants: While blinding participants may be challenging due to the nature of the surgical interventions, efforts will be made to minimise participant bias by emphasising the importance of objective reporting during followup assessments. Data collection process The data collection process for the randomised control trial on managing early avascular necrosis of the femoral head will involve a systematic approach to gathering relevant information at various stages of the study. The data collection process includes the following steps: 1. Preoperative Data Collection: • Clinical Assessment: Demographic details, medical history, and baseline clinical information will be recorded, including age, sex, risk factors, and duration of the illness. • Radiological Assessment: X-ray (AP pelvis with Both hip and Lateral view of the affected hip) and MRI (pelvis with both hips) will be performed for staging AVNFH using the FICAT-ARLET classification. 2. Randomization and Intervention: • Randomization will be conducted, and participants will be allocated to either the Core Decompression with Bisphosphonate Therapy group or the Core Decompression Alone group. • Surgical interventions will be performed according to the assigned group, and data related to the surgical procedure will be documented. 3. Intraoperative Data Collection: • Data related to the intraoperative period, such as the duration of surgery, specific steps taken during core decompression, and any intraoperative complications, will be recorded. 4. Postoperative Care: • Details of postoperative care, including antibiotic administration, analgesic usage, and supplementary medications, will be documented. 5. Laboratory Data: • Blood investigations will be performed preoperatively, including inflammatory parameters (ESR, CRP), coagulation profile (APTT, PT-INR, BT, CT), CBC, homocysteine level, prothrombin time, platelet count, liver function tests (LFT), kidney function tests (KFT), and sickling tests (early and late). 6. Follow-up Visits: • Participants will be scheduled for followup visits at six weeks, three months, six months, and nine months postoperatively. • Clinical data will be collected at each followup, including pain assessment using the Visual Analogue Scale (VAS), 8 range of motion, tenderness, ability to walk, and any signs of instability. • Radiological assessments will be performed at each followup, with an X-ray and MRI if needed. 7. Bisphosphonate Administration (for Odd-numbered Groups): • For participants in the odd-numbered groups receiving bisphosphonate therapy, adherence to alendronate (70 mg) once weekly for nine months will be monitored. 8. Data Validation and Quality Control: • Regular checks for data completeness, accuracy, and consistency will be conducted to ensure the reliability of collected information. • Any missing or inconsistent data will be addressed promptly, and corrective actions will be taken. 9. Data Analysis: • Data analysis will be conducted during the predetermined period (August 2024 to September 2024) using appropriate statistical methods. Data management Effective data management is crucial to ensure the accuracy, security, and integrity of study data throughout the randomised control trial on managing early Avascular Necrosis of the femoral head. 1. Data Collection Tools: Standardized and pre-printed data collection forms will record information consistently. Electronic data capture systems may also be employed for efficient data management. 2. Data Entry: Double data entry will be performed to minimise errors. Data entered electronically or manually will be validated to identify discrepancies and ensure consistency. 3. Data Storage: All collected data will be securely stored in a designated database or file system. Access to the database will be restricted to authorised personnel to maintain confidentiality. 4. Data Security: Strict measures will be implemented to safeguard the confidentiality and integrity of participant data. Password protection, encryption, and regular backup procedures will be employed. 5. Data Monitoring: Periodic data monitoring will be conducted to identify and rectify any inconsistencies, missing data, or outliers. Any changes or corrections to the data will be documented with appropriate justifications. 6. Quality Control: Quality control procedures will be established to ensure the accuracy and reliability of the collected data. This includes routine checks for completeness, accuracy, and adherence to the study protocol. 7. Data Confidentiality: Participant confidentiality will be maintained by assigning unique identifiers rather than using participant names in the dataset. Access to identifiable information will be restricted to authorised personnel. 8. Data Sharing Policy: Data sharing will be governed by institutional policies and ethical considerations. Access to the dataset may be granted to specific individuals or entities based on predefined criteria. 9. Data Analysis: Data analysis will be conducted using statistical software, and the results will be reported in a manner that preserves the anonymity of participants. 10. Data Archiving: Upon completion of the study, all relevant study documents and datasets will be archived according to institutional and regulatory requirements. Statistical method The statistical analysis for the randomised control trial on managing early Avascular Necrosis of the femoral head will employ a comprehensive approach to evaluate the effectiveness of Core Decompression with Bisphosphonate Therapy compared to Core Decompression Alone. Descriptive statistics will summarise demographic characteristics and compare baseline characteristics between groups to assess randomisation success. The primary outcome, changes in the Harris Hip Score over time, will undergo repeated measures analysis of variance or a mixed-effects model. Secondary outcomes, including pain reduction, radiographic changes, complications, and patient satisfaction, will be analysed using appropriate statistical tests. Subgroup analyses may explore variations in treatment effects based on etiological factors. Survival analysis methods may be applied for time-to-event outcomes. Missing data will be handled using imputation methods, and a significance level of 0.05 will be used for hypothesis testing using SPSS version 23. Data visualisation techniques will aid in interpreting trends, and, if applicable, the Data Safety Monitoring Board will review safety and efficacy data at predetermined intervals. The analysis plan, outlined in the study protocol, will guide the statistical methods to ensure a rigorous and meaningful evaluation of the interventions’ impact on Avascular Necrosis of the femoral head management. Ethical considerations Ethical Considerations and Ancillary/Post-Trial Care Approval and Informed Consent: The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has approved the study protocol (Reference number: DMIHER (DU)/IEC/2022/45, Date: 18-07-2022). Additionally, the trial is registered with the Clinical Trials Registry – India (CTRI/2023/09/057253). Before study initiation, written informed consent will be obtained from all participants or their legal guardians, ensuring they are fully informed about the study’s objectives, procedures, potential risks, and benefits. Ancillary/Post-Trial Care Upon the conclusion of the randomised control trial on the management of early Avascular Necrosis of the femoral head, a thorough plan for ancillary and post-trial care will be executed to safeguard the participants’ well-being and ensure the ethical closure of the study. Participants will be informed about the trial’s completion, and details regarding continued medical care and followup appointments will be provided. A post-trial monitoring period will be instituted to assess long-term outcomes and potential complications, with participants monitored for an extended duration to detect any delayed effects or adverse events. Referral pathways and contact information for relevant healthcare providers will be given to facilitate ongoing care for participants requiring further attention. Participants will retain access to trial-related information, including their data, upon request, promoting transparency and addressing any queries or concerns. A summary of the trial results will be shared with participants, fostering transparency and respect in the researcher-participant relationship. Counselling services will be available to address emotional or psychological aspects of participation. Contact information for study coordinators or principal investigators will be provided for an extended period to allow participants to seek clarification or ask questions even after the trial’s completion. Data collected during the trial will be securely stored for an appropriate period, with procedures for data access outlined to protect participant confidentiality. Ethical oversight will persist beyond the trial’s completion, ensuring ongoing consideration of ethical considerations and participant welfare. This comprehensive plan underscores the commitment to ethical research conduct and prioritises the well-being of study participants. Dissemination After the completion of the study, we will publish it in an indexed journal or conference. Study status The study has yet to start. After the publication of the protocol, we will start recruitment in the study. Discussion The proposed randomised control trial investigating the management of early Avascular Necrosis of the femoral head (AVNFH) through core decompression with and without bisphosphonate therapy addresses a critical gap in our understanding of optimal treatment strategies for this debilitating condition. Avascular Necrosis, often associated with significant morbidity and impaired quality of life, necessitates effective interventions to mitigate its progression and impact on hip joint function. The rationale for combining core decompression with bisphosphonate therapy stems from the multifaceted nature of AVNFH, involving both mechanical and metabolic factors. By reducing intraosseous pressure and promoting revascularisation, core decompression has shown promise in alleviating symptoms and preserving joint function. 9 Bisphosphonates, recognised for their anti-resorptive properties, have the potential to modulate bone metabolism and enhance the reparative processes within the femoral head. 2 This proposal is grounded in the broader context of AVNFH management, drawing insights from existing literature and pioneering studies. The work of Agarwala et al., 2 which demonstrated the efficacy of alendronate in AVNFH treatment, is a foundational reference supporting the potential benefits of bisphosphonate therapy. Additionally, the quantitative staging system proposed by Steinberg et al. 4 contributes to understanding AVNFH severity, aiding in patient stratification and treatment decision-making. The proposed study aims to build upon these foundations by systematically evaluating the combined approach of core decompression and bisphosphonate therapy. By incorporating patient-reported outcomes, radiographic assessments, and well-established measures such as the Harris Hip Score, the study aims to comprehensively understand treatment effectiveness and its impact on patients’ functional outcomes. However, the proposed trial also raises several considerations and potential challenges. If previous studies suggest its efficacy, ethical concerns surrounding including a control group without bisphosphonate therapy will be carefully addressed to ensure participant well-being. Additionally, the study’s generalizability may be influenced by the specific characteristics of the study population and variations in etiological factors contributing to AVNFH. Data availability Underlying data No data are associated with this article. Extended data Zenodo Repository: Proforma for the data collections ‘Randomized control trial on managing early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India.” https://doi.org/10.5281/zenodo.10147069 . 10 Reporting guidelines Zenodo Repository: SPIRIT checklist for ‘Randomized control trial on managing early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India’, https://doi.org/10.5281/zenodo.10146733 . Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). References 1. Liu N, Zheng C, Wang Q, et al. : Treatment of non-traumatic avascular necrosis of the femoral head (Review). Exp. Ther. Med. 2022; 23 : 321. PubMed Abstract | Publisher Full Text | Free Full Text 2. Agarwala S, Shah S, Joshi VR: The use of alendronate in the treatment of avascular necrosis of the femoral head: follow-up to eight years. J. Bone Joint Surg. Br. 2009; 91 : 1013–1018. PubMed Abstract | Publisher Full Text 3. Black DM, Cummings SR, Karpf DB, et al. : Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996; 348 : 1535–1541. PubMed Abstract | Publisher Full Text 4. Steinberg ME, Hayken GD, Steinberg DR: A quantitative system for staging avascular necrosis. J. Bone Joint Surg. Br. 1995; 77-B : 34–41. Publisher Full Text 5. Harris Hip Score: Physiopedia. Accessed: December 29, 2023. Reference Source 6. Visual Analogue Scale: Physiopedia. Accessed: December 29, 2023. Reference Source 7. Hsu H, Nallamothu SV: Hip Osteonecrosis. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. 8. Aicher B, Peil H, Peil B, et al. : Pain measurement: Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) in clinical trials with OTC analgesics in headache. Cephalalgia. 2012; 32 : 185–197. PubMed Abstract | Publisher Full Text 9. Mont MA, Hungerford DS: Non-traumatic avascular necrosis of the femoral head. J. Bone Joint Surg. Am. 1995; 77 : 459–474. Publisher Full Text 10. Sindhuja BG: Proforma for the data collections ‘Prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India’. Zenodo. 2023. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 26 Apr 2024 ADD YOUR COMMENT Comment Author details Author details 1 Orthopedic, Datta Meghe Institute of Higher Education & Research, Wardha, 442001, India Ashutosh Lohiya Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Naresh Dhaniwala Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 26 Apr 2024, 13:398 https://doi.org/10.12688/f1000research.146853.1 Copyright © 2024 Lohiya A and Dhaniwala N. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Lohiya A and Dhaniwala N. Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :398 ( https://doi.org/10.12688/f1000research.146853.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 26 Apr 2024 Views 0 Cite How to cite this report: Hailer YD. Reviewer Report For: Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :398 ( https://doi.org/10.5256/f1000research.160976.r285859 ) The direct URL for this report is: https://f1000research.com/articles/13-398/v1#referee-response-285859 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 12 Jun 2024 Yasmin D Hailer , Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.160976.r285859 Thank you for allowing me to review the study. The researchers aim to study the effect of Core Decompression with and without Bisphosphonate Therapy in managing early Avascular Necrosis of the femoral head of skeletally mature patients. ... Continue reading READ ALL Thank you for allowing me to review the study. The researchers aim to study the effect of Core Decompression with and without Bisphosphonate Therapy in managing early Avascular Necrosis of the femoral head of skeletally mature patients. The study design chosen is a randomized control trial. The study is designed as a single-center study. The primary outcome set as a change in Harris Hip Score at 6 weeks three months, six months, and nine months. As secondary outcomes, the study seeks to analyze pain reduction, radiographic changes, and potential complications. Background The background is well-written and incorporates the most important literature. The study is well-designed to answer the research question. The choice of a randomized control trial is appropriate for the research question. Methods: Inclusion criteria: I would recommend inserting not only the stage of the AVNFH but also the classification system used. Do the authors include any ages with AVNFH? Especially female patients can reach skeletal maturity at the age of 12 to 14 years. Are the authors willing to include this age group as well? If so, a special focus on patients’ consent and parents’ consent should be undertaken and stated in the protocol. This should be also added to the section ‘informed consent’. Exclusion criteria: It should be stated that patients who are not able to answer the questionnaire because of different reasons should be excluded. As well as patients with a history of necrosis of the jaw or intolerance to the drug or its components. Sample size calculation The sample size calculation should be explained in more detail. For the primary outcome - change in HHS - what the minimal clinically important difference was taken into consideration? Blinding “Given the nature of the interventions, it may be challenging to blind the participants and the surgical team to the assigned Treatment”; .. While blinding participants may be challenging due to the nature of the surgical interventions … It is unclear why blinding is a problem. All patients undergo surgery and the drug administration can be blinded by giving NaCl. The author should consider this to minimize the placebo effect, having in mind that the primary outcome is a PROM. Follow-up visits The authors should state why the patients will only be followed for nine months postoperatively. Withdrawals/dropouts/Cross-over The authors do not address the potential for withdrawals or dropouts in the study. Nevertheless, they should be prepared to replace such patients, particularly since the power calculation is uncertain even with full recruitment. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Orthopedic Surgery, Epidemiology, AVN, LCPD I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Hailer YD. Reviewer Report For: Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :398 ( https://doi.org/10.5256/f1000research.160976.r285859 ) The direct URL for this report is: https://f1000research.com/articles/13-398/v1#referee-response-285859 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 26 Apr 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 26 Apr 24 read Yasmin D Hailer , Uppsala University Hospital, Uppsala, Sweden Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Hailer Y. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 12 Jun 2024 | for Version 1 Yasmin D Hailer , Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden 0 Views copyright © 2024 Hailer Y. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Thank you for allowing me to review the study. The researchers aim to study the effect of Core Decompression with and without Bisphosphonate Therapy in managing early Avascular Necrosis of the femoral head of skeletally mature patients. The study design chosen is a randomized control trial. The study is designed as a single-center study. The primary outcome set as a change in Harris Hip Score at 6 weeks three months, six months, and nine months. As secondary outcomes, the study seeks to analyze pain reduction, radiographic changes, and potential complications. Background The background is well-written and incorporates the most important literature. The study is well-designed to answer the research question. The choice of a randomized control trial is appropriate for the research question. Methods: Inclusion criteria: I would recommend inserting not only the stage of the AVNFH but also the classification system used. Do the authors include any ages with AVNFH? Especially female patients can reach skeletal maturity at the age of 12 to 14 years. Are the authors willing to include this age group as well? If so, a special focus on patients’ consent and parents’ consent should be undertaken and stated in the protocol. This should be also added to the section ‘informed consent’. Exclusion criteria: It should be stated that patients who are not able to answer the questionnaire because of different reasons should be excluded. As well as patients with a history of necrosis of the jaw or intolerance to the drug or its components. Sample size calculation The sample size calculation should be explained in more detail. For the primary outcome - change in HHS - what the minimal clinically important difference was taken into consideration? Blinding “Given the nature of the interventions, it may be challenging to blind the participants and the surgical team to the assigned Treatment”; .. While blinding participants may be challenging due to the nature of the surgical interventions … It is unclear why blinding is a problem. All patients undergo surgery and the drug administration can be blinded by giving NaCl. The author should consider this to minimize the placebo effect, having in mind that the primary outcome is a PROM. Follow-up visits The authors should state why the patients will only be followed for nine months postoperatively. Withdrawals/dropouts/Cross-over The authors do not address the potential for withdrawals or dropouts in the study. Nevertheless, they should be prepared to replace such patients, particularly since the power calculation is uncertain even with full recruitment. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Orthopedic Surgery, Epidemiology, AVN, LCPD I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Hailer YD. Peer Review Report For: Randomised control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression in tertiary care hospital in central India [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :398 ( https://doi.org/10.5256/f1000research.160976.r285859) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-398/v1#referee-response-285859 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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