A Randomized Control Trial between Reverse Bone Grafting and Core Decompression in Avascular Necrosis of the Femoral Head

A Randomized Control Trial between Reverse Bone Grafting and Core Decompression in Avascular Necrosis of the Femoral Head | 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 Study protocol A Randomized Control Trial between Reverse Bone Grafting and Core Decompression in Avascular Necrosis of the Femoral Head Dhairya Veragiwala, Sandeep Shrivastava This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6200768/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Avascular necrosis (AVN) of the femoral head is a debilitating condition that often leads to progressive joint dysfunction and collapse. Core decompression, with or without reverse bone grafting, is a commonly employed treatment modality. However, there is limited evidence comparing their effectiveness in improving functional and radiological outcomes. Objective This study aimed to compare the functional and radiological outcomes of core decompression with reverse bone grafting versus core decompression without reverse bone grafting in patients with Grade I, II, or III AVN of the femoral head. Methods A randomized controlled trial will be conducted at the Department of Orthopedics, AVBRH, from September 2023 to April 2026. Forty patients were randomly assigned to two groups: Group A (core decompression with reverse bone grafting) and Group B (core decompression without reverse bone grafting). Functional outcomes will be assessed via the Harris Hip Score and Hip Disability and Osteoarthritis Outcome (HOOS) score, whereas radiological parameters will include femoral head density, contour, and revascularization. Pain will be evaluated via the visual analog scale. Follow-up assessments will be conducted at 6 weeks, 12 weeks, and 6 months postoperatively. Expected Outcomes: This study provides insights into the comparative effectiveness of reverse bone grafting in enhancing functional and radiological outcomes in patients with AVN. It is anticipated that, compared with core decompression alone, reverse bone grafting enriched with biologics will result in superior results. Conclusion This study contributes to evidence-based recommendations for optimizing the surgical management of AVN of the femoral head. Avascular necrosis decompression grafting outcomes femoral Background Avascular necrosis (AVN) of the femoral head is a debilitating condition caused by the disruption of the blood supply to the bone, leading to ischemia, bone cell death, and eventual structural collapse. This condition predominantly affects individuals in their third to fifth decades of life, significantly impacting their quality of life and leading to a substantial socioeconomic burden. [ 1 ]. Left untreated, AVN progresses through distinct stages, beginning with asymptomatic bone death and culminating in femoral head collapse and secondary osteoarthritis, often necessitating total hip arthroplasty [ 2 ]. Early intervention is, therefore, critical in preventing disease progression and preserving joint function. The etiology of AVN is multifactorial, with both traumatic and nontraumatic causes. Traumatic etiologies, such as femoral neck fractures or hip dislocations, directly disrupt the vascular supply, whereas nontraumatic etiologies include systemic corticosteroid use, chronic alcohol consumption, and medical conditions such as sickle cell disease, lupus, and antiphospholipid syndrome [ 3 , 4 ]. The pathophysiology involves a complex interplay of vascular occlusion, increased intraosseous pressure, and reduced reparative potential of the bone [ 5 ]. Despite advances in understanding the underlying mechanisms, treatment options remain challenging, especially in advanced stages. Core decompression is one of the most widely utilized surgical interventions for AVN, particularly in the early stages (Ficat and Arlet grades I and II). This minimally invasive procedure aims to reduce intraosseous pressure, stimulate angiogenesis, and facilitate new bone formation, thereby halting disease progression [ 6 ]. However, core decompression alone often yields suboptimal outcomes in advanced stages, prompting the exploration of adjunct techniques to increase its efficacy. One such technique is reverse bone grafting, which involves filling the decompressed cavity with autologous cancellous bone grafts harvested from the iliac crest. This procedure provides structural support to the weakened femoral head and serves as a scaffold for new bone formation. Furthermore, enriching grafts with biologics such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) has gained popularity in recent years because of their potential to increase osteogenesis and vascularisation [ 7 , 8 ]. PRP contains growth factors such as platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF), which promote tissue repair and angiogenesis. Moreover, BMAC is rich in mesenchymal stem cells capable of differentiating into osteoblasts and endothelial cells [ 9 ]. Despite these advancements, high-quality evidence comparing the outcomes of core decompression with and without reverse bone grafting is lacking. Existing studies are often limited by small sample sizes, heterogeneous patient populations, and short follow-up periods, making it difficult to draw definitive conclusions. Additionally, the long-term efficacy of biologic-enhanced grafting techniques in preventing disease progression remains uncertain. Therefore, this randomized controlled trial aims to address these gaps by systematically comparing the functional and radiological outcomes of core decompression with reverse bone grafting versus core decompression alone in patients with Grade I, II, or III AVN of the femoral head. The findings from this study are expected to provide valuable insights into the comparative effectiveness of these surgical techniques, guiding clinicians in selecting the most appropriate treatment strategy for AVN patients. By incorporating biologics into the treatment paradigm, this study also sought to evaluate the potential of regenerative medicine in enhancing clinical outcomes and advancing the management of AVN. Materials and methods Study Design This study is designed as a randomized controlled trial (RCT) aimed at comparing the functional and radiological outcomes of core decompression with reverse bone grafting versus core decompression without reverse bone grafting in patients with avascular necrosis (AVN) of the femoral head. The trial will be conducted at the Department of Orthopedics, Jawaharlal Nehru Medical College, and Acharya Vinobha Bhave Rural Hospital (AVBRH), Sawangi, Wardha, over a period of three years, from September 2023 to April 2026. Study Setting and Population The study will be conducted in a tertiary care teaching hospital equipped with advanced surgical and imaging facilities. The target population will include patients aged 18–60 years who are diagnosed with Grade I, II, or III AVN of the femoral head on the basis of the Ficat and Arlet classification system. These patients will be recruited from the outpatient and inpatient departments of orthopedics after thorough evaluation. Inclusion and Exclusion Criteria Patients will be eligible for inclusion in the study if they are between 18 and 60 years old and have been diagnosed with Grade I, II, or III AVN of the femoral head. Patients who provide informed consent will also be included. The exclusion criteria will include patients with Grade IV AVN; those with ipsilateral comorbidities or deformities affecting the knee, spine, or ankle; and those with systemic conditions that might confound the functional or radiological outcome analysis. Sample size calculation The sample size will be calculated via a standard formula for comparing two groups, with parameters set for a 95% confidence interval and a 7% margin of error. On the basis of these calculations, 40 patients will be required for the study, with 20 patients assigned to each group. This sample size will be sufficient to detect significant differences between the groups while accounting for a possible dropout rate. Randomization and Group Allocation Patients who meet the eligibility criteria will be randomly assigned to one of two groups via a computer-generated randomization sequence. Allocation concealment will be ensured by using sealed opaque envelopes, which will be opened only at the time of intervention. Group A consisted of patients who underwent core decompression with reverse bone grafting, while Group B consisted of patients who underwent core decompression without reverse bone grafting. Data collection The data collection process for this study involved systematic steps to ensure the accuracy and comprehensiveness of the information gathered from the participants. The process spans the preoperative, intraoperative, and postoperative phases, capturing clinical, functional, and radiological data relevant to the objectives of the study. Preoperative Data Collection Upon recruitment, eligible participants will undergo a detailed clinical evaluation to document their baseline characteristics and relevant medical history. A structured platform will be used to collect demographic information, including age, sex, and the side of the affected femoral head (right, left, or bilateral). Additional details, such as history of trauma, alcohol consumption, or any comorbid conditions, will also be recorded. The functional data will be collected via standardized scoring systems, including the Harris Hip Score (HHS) [ 10 ] and the Hip Disability and Osteoarthritis Outcome Score (HOOS) [ 11 ]. These tools provide baseline measures of pain, mobility, stiffness, and the ability to perform daily activities. Pain levels will be assessed via the visual analog scale (VAS) [ 12 ], a validated method for quantifying pain intensity on a 10-point scale. Radiological data, including X-rays (anteroposterior view of the hip) and MRI scans of the affected hip, will be collected through imaging studies. These images help assess key parameters such as femoral head density, contour, revascularization status, and the presence or absence of the crescent sign. Radiological grading was performed via the Ficat and Arlet classification system to confirm the stage of AVN. Intraoperative Data Collection During the surgical procedure, intraoperative data will be documented to ensure consistency and standardization. For participants in Group A , details of the reverse bone grafting procedure, including the quantity and type of graft material used and the addition of biologics such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC), will be recorded. For Group B , the specifics of the core decompression procedure, including the depth and diameter of the decompression channel, are noted. Additional intraoperative parameters, such as the duration of surgery, type of anesthesia used, and any complications encountered, will be meticulously documented to aid in subsequent analysis. Postoperative Data Collection Postoperative follow-up assessments will be conducted at 6 weeks, 12 weeks, and 6 months to evaluate recovery and outcomes. During each follow-up visit, clinical, functional, and radiological data will be collected via the same standardized tools as those used in the preoperative phase to ensure comparability. Clinical data will focus on monitoring pain levels via the VAS, whereas functional outcomes will be assessed through the HHS and HOOS. Changes in these scores over time will provide insights into the effectiveness of the interventions. Radiological data will be updated with new X-rays and MRI scans to evaluate postoperative changes in femoral head density, contour, revascularization, and resolution of the crescent sign. Data Management and Quality Assurance All collected data will be entered into a secure, password-protected electronic database to ensure confidentiality and facilitate analysis. Regular audits will be performed to identify and resolve any discrepancies or missing information. To enhance data reliability, imaging studies will be reviewed independently by two experienced radiologists blinded to the treatment groups. The functional and clinical scores will also be cross-verified by a second investigator. Surgical Interventions Patients in Group A underwent core decompression under fluoroscopic guidance, followed by reverse bone grafting using autologous cancellous bone harvested from the ipsilateral iliac crest. To enhance osteogenesis and vascularisation, bone grafts are enriched with biologics, including platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC). Patients in Group B underwent core decompression without reverse bone grafting. An experienced orthopedic surgeon will perform all surgical procedures to ensure standardization and minimize variability. Follow-Up Schedule Patients will be followed up postoperatively at 6 weeks, 12 weeks, and 6 months. During each follow-up visit, clinical and radiological evaluations will be conducted to monitor recovery and assess outcomes. Clinical assessments will include pain evaluation via the VAS and functional assessments via the Harris Hip Score and HOOS. Radiological evaluations focus on changes in femoral head density, contour, revascularisation, and the presence or resolution of the crescent sign. Statistical analysis All collected data were analyzed via appropriate statistical software. Descriptive statistics, including the means, medians, and standard deviations, will be used to summarize demographic and baseline characteristics. Comparative analyses between the two groups will be performed via an independent t test for continuous variables and the chi-square test for categorical variables. Multivariate regression analysis was used to identify factors influencing the outcomes. Statistical significance will be established at a p value of less than 0.05. Discussion Avascular necrosis (AVN) of the femoral head is a progressive condition that can lead to joint collapse if left untreated. While core decompression is a widely used surgical intervention, its effectiveness can be enhanced by combining it with reverse bone grafting, particularly with the use of biologics such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC). This study aims to address the gap in comparative evidence between these two approaches. Rationale for Core Decompression Core decompression remains a cornerstone in the surgical management of early-stage AVN. Reducing intraosseous pressure alleviates pain and delays disease progression. However, its limitations in advanced cases have prompted the exploration of adjunctive techniques, such as reverse bone grafting. Studies have shown that core decompression alone may not sufficiently restore vascularization, leading to variable outcomes in terms of functional recovery and radiological improvements [ 13 , 14 ]. Role of Reverse Bone Grafting Reverse bone grafting offers structural support and osteoinductive properties, facilitating bone regeneration. The enrichment of grafts with biologics, such as PRP and BMAC, has shown promising results in enhancing angiogenesis and cellular proliferation. These biologics are rich in growth factors, such as vascular endothelial growth factor (VEGF), which play critical roles in revascularization and bone remodeling [ 15 ]. Preliminary studies have reported improved functional outcomes and delayed progression to femoral head collapse when biologics are used alongside core decompression [ 16 , 17 ]. Need for a Randomized Controlled Trial Despite these advancements, the lack of high-quality randomized controlled trials comparing core decompression with and without reverse bone grafting necessitates further investigation. Previous studies have often been limited by small sample sizes, heterogeneous patient populations, and inconsistent methodologies [ 18 ]. This study protocol aims to overcome these limitations by employing a rigorous design with well-defined inclusion criteria, standardized surgical techniques, and comprehensive follow-up assessments. Anticipated Outcomes The functional outcomes will be assessed via validated tools such as the Harris Hip Score and Hip Disability and Osteoarthritis Outcome (HOOS) score. Moreover, the radiological parameters included femoral head density, contour, and revascularization. It is hypothesized that reverse bone grafting, enriched with biologics, will lead to superior outcomes in terms of pain reduction, functional recovery, and prevention of disease progression. These results could provide robust evidence for incorporating biologics into routine surgical practice for AVN management. Challenges and limitations The protocol acknowledges potential challenges, including the relatively short follow-up period of six months and the small sample size, which may limit the generalizability of the findings. Additionally, as a single-center study, variations in surgical expertise and patient demographics across institutions may not be captured. Future multicenter studies with longer follow-up periods will be essential to validate the findings and establish long-term benefits [ 8 ]. Implications for Future Research This protocol lays the groundwork for future studies to explore the cost-effectiveness and broader applicability of reverse bone grafting in AVN. The integration of advanced imaging modalities, such as dynamic contrast-enhanced MRI, could further enhance the understanding of revascularization processes and graft incorporation. Declarations Author Contribution Concept and design: Dhairya Veragiwala, Sandeep ShrivastavaAcquisition, analysis, or interpretation of data: Dhairya Veragiwala, Sandeep ShrivastavaDrafting of the manuscript: Dhairya Veragiwala, Sandeep ShrivastavaCritical review of the manuscript for important intellectual content: Dhairya Veragiwala, Sandeep ShrivastavaSupervision: Dhairya Veragiwala, Sandeep Shrivastava Ethics committee approval This study has been approved by the Ethics committee Funding declaration This study has not been funded by any organisation or institution. References Mont MA, Zywiel MG, Marker DR, McGrath MS, Delanois RE: The natural history of untreated asymptomatic osteonecrosis of the femoral head: a systematic literature review. J Bone Joint Surg Am. 2010, 92:2165–70. 10.2106/JBJS.I.00575 Moya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM: Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015, 6:590–601. 10.5312/wjo.v6.i8.590 Barney J, Piuzzi NS, Akhondi H: Femoral Head Avascular Necrosis. In: StatPearls. StatPearls Publishing: Treasure Island (FL); 2025. Assouline-Dayan Y, Chang C, Greenspan A, Shoenfeld Y, Gershwin ME: Pathogenesis and natural history of osteonecrosis. Semin Arthritis Rheum. 2002, 32:94–124. Jones LC, Hungerford DS: Osteonecrosis: etiology, diagnosis, and treatment. Curr Opin Rheumatol. 2004, 16:443–9. 10.1097/01.moo.0000127829.34643.fd Scheidt MD, Aiyash S, Salazar D, Garbis N: Core decompression for early-stage avascular necrosis of the humeral head: current concepts and techniques. Clin Shoulder Elb. 2022, 26:191–204. 10.5397/cise.2022.00969 Tabatabaee RM, Saberi S, Parvizi J, Mortazavi SMJ, Farzan M: Combining Concentrated Autologous Bone Marrow Stem Cells Injection With Core Decompression Improves Outcome for Patients with Early-Stage Osteonecrosis of the Femoral Head: A Comparative Study. J Arthroplasty. 2015, 30:11–5. 10.1016/j.arth.2015.06.022 Sen RK: Management of avascular necrosis of femoral head at precollapse stage. Indian J Orthop. 2009, 43:6–16. 10.4103/0019-5413.45318 Wang Z, Sun Q-M, Zhang F-Q, Zhang Q-L, Wang L-G, Wang W-J: Core decompression combined with autologous bone marrow stem cells versus core decompression alone for patients with osteonecrosis of the femoral head: A meta-analysis. Int J Surg. 2019, 69:23–31. 10.1016/j.ijsu.2019.06.016 Harris Hip Score. Physiopedia. Accessed: January 8, 2025. https://www.physio-pedia.com/Harris_Hip_Score. Hip Disability and Osteoarthritis Outcome Score. Physiopedia. Accessed: January 8, 2025. https://www.physio-pedia.com/Hip_Disability_and_Osteoarthritis_Outcome_Score. Visual Analog Scale. Physiopedia. Accessed: January 8, 2025. https://www.physio-pedia.com/Visual_Analogue_Scale. Mont MA, Salem HS, Piuzzi NS, Goodman SB, Jones LC: Nontraumatic Osteonecrosis of the Femoral Head: Where Do We Stand Today? J Bone Joint Surg Am. 2020, 102:1084–99. 10.2106/JBJS.19.01271 Bian Y, Hu T, Lv Z, et al.: Bone tissue engineering for treating osteonecrosis of the femoral head. Exploration (Beijing). 2023, 3:20210105. 10.1002/EXP.20210105 Hernigou P, Poignard A, Beaujean F, Rouard H: Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005, 87:1430–7. 10.2106/JBJS.D.02215 Han J, Gao F, Li Y, et al.: The Use of Platelet-Rich Plasma for the Treatment of Osteonecrosis of the Femoral Head: A Systematic Review. Biomed Res Int. 2020, 2020:2642439. 10.1155/2020/2642439 Zhao D, Cui D, Wang B, et al.: Treatment of early stage osteonecrosis of the femoral head with autologous implantation of bone marrow-derived and cultured mesenchymal stem cells. Bone. 2012, 50:325–30. 10.1016/j.bone.2011.11.002 Koo KH, Kim R, Ko GH, Song HR, Jeong ST, Cho SH: Preventing collapse in early osteonecrosis of the femoral head. A randomized clinical trial of core decompression. J Bone Joint Surg Br. 1995, 77:870–4. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted 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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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6200768","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":428602253,"identity":"fa42fe93-00a1-418a-944b-60a83d0119db","order_by":0,"name":"Dhairya Veragiwala","email":"data:image/png;base64,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","orcid":"","institution":"Jawaharlal Nehru Medical College","correspondingAuthor":true,"prefix":"","firstName":"Dhairya","middleName":"","lastName":"Veragiwala","suffix":""},{"id":428602254,"identity":"25804d4c-768f-4b1a-b029-9e05b0595201","order_by":1,"name":"Sandeep Shrivastava","email":"","orcid":"","institution":"Jawaharlal Nehru Medical College","correspondingAuthor":false,"prefix":"","firstName":"Sandeep","middleName":"","lastName":"Shrivastava","suffix":""}],"badges":[],"createdAt":"2025-03-11 07:08:26","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6200768/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6200768/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":79726670,"identity":"8d7aa454-703a-4edc-b09d-98e4a7196e68","added_by":"auto","created_at":"2025-04-02 04:17:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":640533,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6200768/v1/af54a0fe-4793-48dc-9745-8808f8be2129.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Randomized Control Trial between Reverse Bone Grafting and Core Decompression in Avascular Necrosis of the Femoral Head","fulltext":[{"header":"Background","content":"\u003cp\u003eAvascular necrosis (AVN) of the femoral head is a debilitating condition caused by the disruption of the blood supply to the bone, leading to ischemia, bone cell death, and eventual structural collapse. This condition predominantly affects individuals in their third to fifth decades of life, significantly impacting their quality of life and leading to a substantial socioeconomic burden. [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Left untreated, AVN progresses through distinct stages, beginning with asymptomatic bone death and culminating in femoral head collapse and secondary osteoarthritis, often necessitating total hip arthroplasty [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Early intervention is, therefore, critical in preventing disease progression and preserving joint function.\u003c/p\u003e \u003cp\u003eThe etiology of AVN is multifactorial, with both traumatic and nontraumatic causes. Traumatic etiologies, such as femoral neck fractures or hip dislocations, directly disrupt the vascular supply, whereas nontraumatic etiologies include systemic corticosteroid use, chronic alcohol consumption, and medical conditions such as sickle cell disease, lupus, and antiphospholipid syndrome [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The pathophysiology involves a complex interplay of vascular occlusion, increased intraosseous pressure, and reduced reparative potential of the bone [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Despite advances in understanding the underlying mechanisms, treatment options remain challenging, especially in advanced stages.\u003c/p\u003e \u003cp\u003eCore decompression is one of the most widely utilized surgical interventions for AVN, particularly in the early stages (Ficat and Arlet grades I and II). This minimally invasive procedure aims to reduce intraosseous pressure, stimulate angiogenesis, and facilitate new bone formation, thereby halting disease progression [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. However, core decompression alone often yields suboptimal outcomes in advanced stages, prompting the exploration of adjunct techniques to increase its efficacy.\u003c/p\u003e \u003cp\u003eOne such technique is reverse bone grafting, which involves filling the decompressed cavity with autologous cancellous bone grafts harvested from the iliac crest. This procedure provides structural support to the weakened femoral head and serves as a scaffold for new bone formation. Furthermore, enriching grafts with biologics such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) has gained popularity in recent years because of their potential to increase osteogenesis and vascularisation [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. PRP contains growth factors such as platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF), which promote tissue repair and angiogenesis. Moreover, BMAC is rich in mesenchymal stem cells capable of differentiating into osteoblasts and endothelial cells [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite these advancements, high-quality evidence comparing the outcomes of core decompression with and without reverse bone grafting is lacking. Existing studies are often limited by small sample sizes, heterogeneous patient populations, and short follow-up periods, making it difficult to draw definitive conclusions. Additionally, the long-term efficacy of biologic-enhanced grafting techniques in preventing disease progression remains uncertain. Therefore, this randomized controlled trial aims to address these gaps by systematically comparing the functional and radiological outcomes of core decompression with reverse bone grafting versus core decompression alone in patients with Grade I, II, or III AVN of the femoral head.\u003c/p\u003e \u003cp\u003eThe findings from this study are expected to provide valuable insights into the comparative effectiveness of these surgical techniques, guiding clinicians in selecting the most appropriate treatment strategy for AVN patients. By incorporating biologics into the treatment paradigm, this study also sought to evaluate the potential of regenerative medicine in enhancing clinical outcomes and advancing the management of AVN.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eThis study is designed as a randomized controlled trial (RCT) aimed at comparing the functional and radiological outcomes of core decompression with reverse bone grafting versus core decompression without reverse bone grafting in patients with avascular necrosis (AVN) of the femoral head. The trial will be conducted at the Department of Orthopedics, Jawaharlal Nehru Medical College, and Acharya Vinobha Bhave Rural Hospital (AVBRH), Sawangi, Wardha, over a period of three years, from September 2023 to April 2026.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy Setting and Population\u003c/h3\u003e\n\u003cp\u003eThe study will be conducted in a tertiary care teaching hospital equipped with advanced surgical and imaging facilities. The target population will include patients aged 18\u0026ndash;60 years who are diagnosed with Grade I, II, or III AVN of the femoral head on the basis of the Ficat and Arlet classification system. These patients will be recruited from the outpatient and inpatient departments of orthopedics after thorough evaluation.\u003c/p\u003e\n\u003ch3\u003eInclusion and Exclusion Criteria\u003c/h3\u003e\n\u003cp\u003ePatients will be eligible for inclusion in the study if they are between 18 and 60 years old and have been diagnosed with Grade I, II, or III AVN of the femoral head. Patients who provide informed consent will also be included. The exclusion criteria will include patients with Grade IV AVN; those with ipsilateral comorbidities or deformities affecting the knee, spine, or ankle; and those with systemic conditions that might confound the functional or radiological outcome analysis.\u003c/p\u003e\n\u003ch3\u003eSample size calculation\u003c/h3\u003e\n\u003cp\u003eThe sample size will be calculated via a standard formula for comparing two groups, with parameters set for a 95% confidence interval and a 7% margin of error. On the basis of these calculations, 40 patients will be required for the study, with 20 patients assigned to each group. This sample size will be sufficient to detect significant differences between the groups while accounting for a possible dropout rate.\u003c/p\u003e\n\u003ch3\u003eRandomization and Group Allocation\u003c/h3\u003e\n\u003cp\u003ePatients who meet the eligibility criteria will be randomly assigned to one of two groups via a computer-generated randomization sequence. Allocation concealment will be ensured by using sealed opaque envelopes, which will be opened only at the time of intervention. Group A consisted of patients who underwent core decompression with reverse bone grafting, while Group B consisted of patients who underwent core decompression without reverse bone grafting.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eThe data collection process for this study involved systematic steps to ensure the accuracy and comprehensiveness of the information gathered from the participants. The process spans the preoperative, intraoperative, and postoperative phases, capturing clinical, functional, and radiological data relevant to the objectives of the study.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePreoperative Data Collection\u003c/h3\u003e\n\u003cp\u003eUpon recruitment, eligible participants will undergo a detailed clinical evaluation to document their baseline characteristics and relevant medical history. A structured platform will be used to collect demographic information, including age, sex, and the side of the affected femoral head (right, left, or bilateral). Additional details, such as history of trauma, alcohol consumption, or any comorbid conditions, will also be recorded.\u003c/p\u003e \u003cp\u003eThe functional data will be collected via standardized scoring systems, including the \u003cb\u003eHarris Hip Score (HHS)\u003c/b\u003e [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] and the \u003cb\u003eHip Disability and Osteoarthritis Outcome Score (HOOS)\u003c/b\u003e [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. These tools provide baseline measures of pain, mobility, stiffness, and the ability to perform daily activities. Pain levels will be assessed via the \u003cb\u003evisual analog scale (VAS)\u003c/b\u003e [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], a validated method for quantifying pain intensity on a 10-point scale.\u003c/p\u003e \u003cp\u003eRadiological data, including \u003cb\u003eX-rays\u003c/b\u003e (anteroposterior view of the hip) and \u003cb\u003eMRI scans\u003c/b\u003e of the affected hip, will be collected through imaging studies. These images help assess key parameters such as femoral head density, contour, revascularization status, and the presence or absence of the crescent sign. Radiological grading was performed via the Ficat and Arlet classification system to confirm the stage of AVN.\u003c/p\u003e\n\u003ch3\u003eIntraoperative Data Collection\u003c/h3\u003e\n\u003cp\u003eDuring the surgical procedure, intraoperative data will be documented to ensure consistency and standardization. For participants in \u003cb\u003eGroup A\u003c/b\u003e, details of the reverse bone grafting procedure, including the quantity and type of graft material used and the addition of biologics such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC), will be recorded. For \u003cb\u003eGroup B\u003c/b\u003e, the specifics of the core decompression procedure, including the depth and diameter of the decompression channel, are noted.\u003c/p\u003e \u003cp\u003eAdditional intraoperative parameters, such as the duration of surgery, type of anesthesia used, and any complications encountered, will be meticulously documented to aid in subsequent analysis.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003ePostoperative Data Collection\u003c/h2\u003e \u003cp\u003ePostoperative follow-up assessments will be conducted at \u003cb\u003e6 weeks, 12 weeks, and 6 months\u003c/b\u003e to evaluate recovery and outcomes. During each follow-up visit, clinical, functional, and radiological data will be collected via the same standardized tools as those used in the preoperative phase to ensure comparability.\u003c/p\u003e \u003cp\u003eClinical data will focus on monitoring pain levels via the VAS, whereas functional outcomes will be assessed through the HHS and HOOS. Changes in these scores over time will provide insights into the effectiveness of the interventions. Radiological data will be updated with new X-rays and MRI scans to evaluate postoperative changes in femoral head density, contour, revascularization, and resolution of the crescent sign.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eData Management and Quality Assurance\u003c/h2\u003e \u003cp\u003eAll collected data will be entered into a secure, password-protected electronic database to ensure confidentiality and facilitate analysis. Regular audits will be performed to identify and resolve any discrepancies or missing information. To enhance data reliability, imaging studies will be reviewed independently by two experienced radiologists blinded to the treatment groups. The functional and clinical scores will also be cross-verified by a second investigator.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSurgical Interventions\u003c/h2\u003e \u003cp\u003ePatients in Group A underwent core decompression under fluoroscopic guidance, followed by reverse bone grafting using autologous cancellous bone harvested from the ipsilateral iliac crest. To enhance osteogenesis and vascularisation, bone grafts are enriched with biologics, including platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC). Patients in Group B underwent core decompression without reverse bone grafting. An experienced orthopedic surgeon will perform all surgical procedures to ensure standardization and minimize variability.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eFollow-Up Schedule\u003c/h2\u003e \u003cp\u003ePatients will be followed up postoperatively at 6 weeks, 12 weeks, and 6 months. During each follow-up visit, clinical and radiological evaluations will be conducted to monitor recovery and assess outcomes. Clinical assessments will include pain evaluation via the VAS and functional assessments via the Harris Hip Score and HOOS. Radiological evaluations focus on changes in femoral head density, contour, revascularisation, and the presence or resolution of the crescent sign.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll collected data were analyzed via appropriate statistical software. Descriptive statistics, including the means, medians, and standard deviations, will be used to summarize demographic and baseline characteristics. Comparative analyses between the two groups will be performed via an independent t test for continuous variables and the chi-square test for categorical variables. Multivariate regression analysis was used to identify factors influencing the outcomes. Statistical significance will be established at a p value of less than 0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eAvascular necrosis (AVN) of the femoral head is a progressive condition that can lead to joint collapse if left untreated. While core decompression is a widely used surgical intervention, its effectiveness can be enhanced by combining it with reverse bone grafting, particularly with the use of biologics such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC). This study aims to address the gap in comparative evidence between these two approaches.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eRationale for Core Decompression\u003c/h2\u003e \u003cp\u003eCore decompression remains a cornerstone in the surgical management of early-stage AVN. Reducing intraosseous pressure alleviates pain and delays disease progression. However, its limitations in advanced cases have prompted the exploration of adjunctive techniques, such as reverse bone grafting. Studies have shown that core decompression alone may not sufficiently restore vascularization, leading to variable outcomes in terms of functional recovery and radiological improvements [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eRole of Reverse Bone Grafting\u003c/h2\u003e \u003cp\u003eReverse bone grafting offers structural support and osteoinductive properties, facilitating bone regeneration. The enrichment of grafts with biologics, such as PRP and BMAC, has shown promising results in enhancing angiogenesis and cellular proliferation. These biologics are rich in growth factors, such as vascular endothelial growth factor (VEGF), which play critical roles in revascularization and bone remodeling [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Preliminary studies have reported improved functional outcomes and delayed progression to femoral head collapse when biologics are used alongside core decompression [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eNeed for a Randomized Controlled Trial\u003c/h2\u003e \u003cp\u003eDespite these advancements, the lack of high-quality randomized controlled trials comparing core decompression with and without reverse bone grafting necessitates further investigation. Previous studies have often been limited by small sample sizes, heterogeneous patient populations, and inconsistent methodologies [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. This study protocol aims to overcome these limitations by employing a rigorous design with well-defined inclusion criteria, standardized surgical techniques, and comprehensive follow-up assessments.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eAnticipated Outcomes\u003c/h2\u003e \u003cp\u003eThe functional outcomes will be assessed via validated tools such as the Harris Hip Score and Hip Disability and Osteoarthritis Outcome (HOOS) score. Moreover, the radiological parameters included femoral head density, contour, and revascularization. It is hypothesized that reverse bone grafting, enriched with biologics, will lead to superior outcomes in terms of pain reduction, functional recovery, and prevention of disease progression. These results could provide robust evidence for incorporating biologics into routine surgical practice for AVN management.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eChallenges and limitations\u003c/h2\u003e \u003cp\u003eThe protocol acknowledges potential challenges, including the relatively short follow-up period of six months and the small sample size, which may limit the generalizability of the findings. Additionally, as a single-center study, variations in surgical expertise and patient demographics across institutions may not be captured. Future multicenter studies with longer follow-up periods will be essential to validate the findings and establish long-term benefits [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eImplications for Future Research\u003c/h2\u003e \u003cp\u003eThis protocol lays the groundwork for future studies to explore the cost-effectiveness and broader applicability of reverse bone grafting in AVN. The integration of advanced imaging modalities, such as dynamic contrast-enhanced MRI, could further enhance the understanding of revascularization processes and graft incorporation.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eConcept and design: Dhairya Veragiwala, Sandeep ShrivastavaAcquisition, analysis, or interpretation of data: Dhairya Veragiwala, Sandeep ShrivastavaDrafting of the manuscript: Dhairya Veragiwala, Sandeep ShrivastavaCritical review of the manuscript for important intellectual content: Dhairya Veragiwala, Sandeep ShrivastavaSupervision: Dhairya Veragiwala, Sandeep Shrivastava\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEthics committee approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has been approved by the Ethics committee\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding \u0026nbsp;declaration\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has not been funded by any organisation or institution.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMont MA, Zywiel MG, Marker DR, McGrath MS, Delanois RE: The natural history of untreated asymptomatic osteonecrosis of the femoral head: a systematic literature review. J Bone Joint Surg Am. 2010, 92:2165\u0026ndash;70. 10.2106/JBJS.I.00575\u003c/li\u003e\n\u003cli\u003eMoya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM: Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015, 6:590\u0026ndash;601. 10.5312/wjo.v6.i8.590\u003c/li\u003e\n\u003cli\u003eBarney J, Piuzzi NS, Akhondi H: Femoral Head Avascular Necrosis. In: StatPearls. StatPearls Publishing: Treasure Island (FL); 2025.\u003c/li\u003e\n\u003cli\u003eAssouline-Dayan Y, Chang C, Greenspan A, Shoenfeld Y, Gershwin ME: Pathogenesis and natural history of osteonecrosis. Semin Arthritis Rheum. 2002, 32:94\u0026ndash;124.\u003c/li\u003e\n\u003cli\u003eJones LC, Hungerford DS: Osteonecrosis: etiology, diagnosis, and treatment. Curr Opin Rheumatol. 2004, 16:443\u0026ndash;9. 10.1097/01.moo.0000127829.34643.fd\u003c/li\u003e\n\u003cli\u003eScheidt MD, Aiyash S, Salazar D, Garbis N: Core decompression for early-stage avascular necrosis of the humeral head: current concepts and techniques. Clin Shoulder Elb. 2022, 26:191\u0026ndash;204. 10.5397/cise.2022.00969\u003c/li\u003e\n\u003cli\u003eTabatabaee RM, Saberi S, Parvizi J, Mortazavi SMJ, Farzan M: Combining Concentrated Autologous Bone Marrow Stem Cells Injection With Core Decompression Improves Outcome for Patients with Early-Stage Osteonecrosis of the Femoral Head: A Comparative Study. J Arthroplasty. 2015, 30:11\u0026ndash;5. 10.1016/j.arth.2015.06.022\u003c/li\u003e\n\u003cli\u003eSen RK: Management of avascular necrosis of femoral head at precollapse stage. Indian J Orthop. 2009, 43:6\u0026ndash;16. 10.4103/0019-5413.45318\u003c/li\u003e\n\u003cli\u003eWang Z, Sun Q-M, Zhang F-Q, Zhang Q-L, Wang L-G, Wang W-J: Core decompression combined with autologous bone marrow stem cells versus core decompression alone for patients with osteonecrosis of the femoral head: A meta-analysis. Int J Surg. 2019, 69:23\u0026ndash;31. 10.1016/j.ijsu.2019.06.016\u003c/li\u003e\n\u003cli\u003eHarris Hip Score. Physiopedia. Accessed: January 8, 2025. https://www.physio-pedia.com/Harris_Hip_Score.\u003c/li\u003e\n\u003cli\u003eHip Disability and Osteoarthritis Outcome Score. Physiopedia. Accessed: January 8, 2025. https://www.physio-pedia.com/Hip_Disability_and_Osteoarthritis_Outcome_Score.\u003c/li\u003e\n\u003cli\u003eVisual Analog Scale. Physiopedia. Accessed: January 8, 2025. https://www.physio-pedia.com/Visual_Analogue_Scale.\u003c/li\u003e\n\u003cli\u003eMont MA, Salem HS, Piuzzi NS, Goodman SB, Jones LC: Nontraumatic Osteonecrosis of the Femoral Head: Where Do We Stand Today? J Bone Joint Surg Am. 2020, 102:1084\u0026ndash;99. 10.2106/JBJS.19.01271\u003c/li\u003e\n\u003cli\u003eBian Y, Hu T, Lv Z, et al.: Bone tissue engineering for treating osteonecrosis of the femoral head. Exploration (Beijing). 2023, 3:20210105. 10.1002/EXP.20210105\u003c/li\u003e\n\u003cli\u003eHernigou P, Poignard A, Beaujean F, Rouard H: Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005, 87:1430\u0026ndash;7. 10.2106/JBJS.D.02215\u003c/li\u003e\n\u003cli\u003eHan J, Gao F, Li Y, et al.: The Use of Platelet-Rich Plasma for the Treatment of Osteonecrosis of the Femoral Head: A Systematic Review. Biomed Res Int. 2020, 2020:2642439. 10.1155/2020/2642439\u003c/li\u003e\n\u003cli\u003eZhao D, Cui D, Wang B, et al.: Treatment of early stage osteonecrosis of the femoral head with autologous implantation of bone marrow-derived and cultured mesenchymal stem cells. Bone. 2012, 50:325\u0026ndash;30. 10.1016/j.bone.2011.11.002\u003c/li\u003e\n\u003cli\u003eKoo KH, Kim R, Ko GH, Song HR, Jeong ST, Cho SH: Preventing collapse in early osteonecrosis of the femoral head. A randomized clinical trial of core decompression. J Bone Joint Surg Br. 1995, 77:870\u0026ndash;4.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Avascular, necrosis, decompression, grafting, outcomes, femoral","lastPublishedDoi":"10.21203/rs.3.rs-6200768/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6200768/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAvascular necrosis (AVN) of the femoral head is a debilitating condition that often leads to progressive joint dysfunction and collapse. Core decompression, with or without reverse bone grafting, is a commonly employed treatment modality. However, there is limited evidence comparing their effectiveness in improving functional and radiological outcomes.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eThis study aimed to compare the functional and radiological outcomes of core decompression with reverse bone grafting versus core decompression without reverse bone grafting in patients with Grade I, II, or III AVN of the femoral head.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA randomized controlled trial will be conducted at the Department of Orthopedics, AVBRH, from September 2023 to April 2026. Forty patients were randomly assigned to two groups: Group A (core decompression with reverse bone grafting) and Group B (core decompression without reverse bone grafting). Functional outcomes will be assessed via the Harris Hip Score and Hip Disability and Osteoarthritis Outcome (HOOS) score, whereas radiological parameters will include femoral head density, contour, and revascularization. Pain will be evaluated via the visual analog scale. Follow-up assessments will be conducted at 6 weeks, 12 weeks, and 6 months postoperatively.\u003c/p\u003e\u003ch2\u003eExpected Outcomes:\u003c/h2\u003e \u003cp\u003eThis study provides insights into the comparative effectiveness of reverse bone grafting in enhancing functional and radiological outcomes in patients with AVN. It is anticipated that, compared with core decompression alone, reverse bone grafting enriched with biologics will result in superior results.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThis study contributes to evidence-based recommendations for optimizing the surgical management of AVN of the femoral head.\u003c/p\u003e","manuscriptTitle":"A Randomized Control Trial between Reverse Bone Grafting and Core Decompression in Avascular Necrosis of the Femoral Head","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-17 09:17:42","doi":"10.21203/rs.3.rs-6200768/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ffd127ad-1957-426c-882e-f6ce2afc994c","owner":[],"postedDate":"March 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-02T04:09:03+00:00","versionOfRecord":[],"versionCreatedAt":"2025-03-17 09:17:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6200768","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6200768","identity":"rs-6200768","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}