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Birmingham Hip Resurfacing: a retrospective cohort study of clinical, biochemical, and radiological outcomes in a non-designer centre at minimum 15 years' follow-up.
IF 2.8
Bone & Joint Open Pub Date : 2025-04-08 DOI: 10.1302/2633-1462.64.BJO-2025-0003.R1
Martin S Davey, Conor Farrell, Conor Kilkenny, Conor Medlar, Niall P McGoldrick, John F Quinlan
{"title":"Birmingham Hip Resurfacing: a retrospective cohort study of clinical, biochemical, and radiological outcomes in a non-designer centre at minimum 15 years' follow-up.","authors":"Martin S Davey, Conor Farrell, Conor Kilkenny, Conor Medlar, Niall P McGoldrick, John F Quinlan","doi":"10.1302/2633-1462.64.BJO-2025-0003.R1","DOIUrl":"https://doi.org/10.1302/2633-1462.64.BJO-2025-0003.R1","url":null,"abstract":"<p><strong>Aims: </strong>Although the use of metal-on-metal (MoM) implants in total hip arthroplasty (THA) remains a topic of controversy, prior literature has reported satisfactory ten-year clinical and radiological outcomes following Birmingham Hip Resurfacing (BHR), subsequently resulting in a recent Orthopaedic Data Evaluation Panel (ODEP) rating of 15 A*. Therefore, the purpose of this study was to evaluate the functional outcomes, radiological outcomes, and revision rates following BHR at a minimum of 15 years' follow-up in a non-designer centre.</p><p><strong>Methods: </strong>Two investigators performed a retrospective review to identify consecutive patients who underwent BHR in our institution over a seven-year period (2003 to 2009, at minimum 15 years' follow-up) in a non-designer centre. Evaluation of clinical (Oxford Hip Scores (OHS)), biochemical (cobalt and chromium levels), and radiological (plain film radiographs) outcomes was carried out. Survivorship analysis was performed using Kaplan-Meier curves, with all-cause surgical revision defined as a definitive endpoint for analysis. Descriptive statistical analysis was carried out.</p><p><strong>Results: </strong>Overall, 96 patients (86 males) at a mean age of 51.4 years (SD 9.9; 27 to 69) underwent 105 BHR procedures (nine bilateral) with at least 15 years' minimum follow-up. Mean OHS was 38.3 (SD 9.6; 17 to 48) at 15-year minimum follow-up. The overall survivorship was 94.3% at 15 years post BHR, with an all-cause revision rate of 5.7%. Only eight BHR prostheses (8.2%) had radiolucent lines on plain films, none of which were listed for revision at the time of latest follow-up, while 32 patients had undergone MRI at 170 months (SD 54.9; 6 to 249) post BHR, with evidence of fluid collection, aseptic lymphocyte-dominant vasculitis-associated lesion, and metallosis identified on the MRI of four patients, four patients, and one patient, respectively. For 98.4% (60/61) of patients, cobalt and chromium values were either within normal limits (68.9%, n = 42) or less than double the upper limit of normal (29.5%, n = 18).</p><p><strong>Conclusion: </strong>This study found that BHR demonstrates an acceptable survivorship of 94% at 15 years of minimum follow-up, with satisfactory clinical and radiological outcomes to reflect this low all-cause revision rate in a non-designer centre.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 4","pages":"413-418"},"PeriodicalIF":2.8,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preoperative chronic opiate use associated with a worse joint-specific function and quality of life before and after total hip and knee arthroplasty.
IF 2.8
Bone & Joint Open Pub Date : 2025-04-07 DOI: 10.1302/2633-1462.64.BJO-2024-0250.R1
Eliott S Martinson, Nick D Clement, Deborah J MacDonald, Chloe E H Scott, Colin R Howie
{"title":"Preoperative chronic opiate use associated with a worse joint-specific function and quality of life before and after total hip and knee arthroplasty.","authors":"Eliott S Martinson, Nick D Clement, Deborah J MacDonald, Chloe E H Scott, Colin R Howie","doi":"10.1302/2633-1462.64.BJO-2024-0250.R1","DOIUrl":"10.1302/2633-1462.64.BJO-2024-0250.R1","url":null,"abstract":"<p><strong>Aims: </strong>The aim of this study was to assess whether chronic pre-arthroplasty use of strong opiates impacted the pre- and postoperative joint-specific function, quality of life (QoL), pain scores, and satisfaction in those undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA).</p><p><strong>Methods: </strong>This prospective study assessed 1,487 patients (THA n = 729; TKA n = 758). Preoperative opiate use of more than a month was used to define the opioid group. Patient demographics, comorbidities, Oxford Hip Score (OHS), Oxford Knee Score (OKS), and EuroQol five-dimension questionnaire (EQ-5D) scores were collected preoperatively and at six months postoperatively. Patient satisfaction with their joint was assessed at six months.</p><p><strong>Results: </strong>The opioid groups consisted of 95 patients in both the THA (13.0%) and TKA (12.5%) cohorts. Pre- and postoperative OHS, OKS, and EQ-5D were clinically (greater than the minimal clinically important difference) and statistically (p < 0.001) significantly worse for the opioid groups undergoing THA and TKA. The opioid group was independently associated with a significantly worse improvement in OHS (-3.0, 95% CI -4.8 to -1.2; p = 0.001) and EQ-5D (-0.089, 95% CI -0.132 to -0.041; p < 0.001) for those undergoing THA, but no significant (OKS, p = 0.650 and EQ-5D, p = 0.485) association was demonstrated in the TKA cohort. There was no difference in satisfaction with their arthroplasty between opioid and opiate-naive groups undergoing THA (p = 0.133) or TKA (p = 0.797).</p><p><strong>Conclusion: </strong>Preoperative opiate use was associated with clinically significantly worse pre- and postoperative joint-specific function and QoL. Those undergoing THA had a clinically worse improvement in their joint-specific function, but this was not observed in those undergoing TKA. However, patients were equally satisfied with outcomes.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 4","pages":"405-412"},"PeriodicalIF":2.8,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11972797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
SPAIRE approach shows equivalent changes in bone mineral density as a conventional approach in femoral neck fracture patients : a sub-group analysis of 49 patients from a randomized controlled trial. 在股骨颈骨折患者中,SPAIRE方法与传统方法显示出相同的骨矿物质密度变化:对随机对照试验中49名患者的分组分析。
IF 2.8
Bone & Joint Open Pub Date : 2025-04-05 DOI: 10.1302/2633-1462.64.BJO-2024-0171.R1
Stein H Ugland, Terje O Ugland, Knut E Mjaaland, Oystein T Fagerberg, Glenn Haugeberg, Are H Pripp, Lars Nordsletten
{"title":"SPAIRE approach shows equivalent changes in bone mineral density as a conventional approach in femoral neck fracture patients : a sub-group analysis of 49 patients from a randomized controlled trial.","authors":"Stein H Ugland, Terje O Ugland, Knut E Mjaaland, Oystein T Fagerberg, Glenn Haugeberg, Are H Pripp, Lars Nordsletten","doi":"10.1302/2633-1462.64.BJO-2024-0171.R1","DOIUrl":"10.1302/2633-1462.64.BJO-2024-0171.R1","url":null,"abstract":"<p><strong>Aims: </strong>The incidence of periprosthetic fractures is increasing and, in 2023, was the main reason for revision arthroplasty in Norway. Some studies indicate that the surgical approach affects periprosthetic bone density and possibly could influence fracture risk. The SPAIRE (sparing piriformis and obturator internus, repairing externus) approach is gaining popularity. As a relatively novel surgical approach, we designed a randomized controlled trial (RCT) comparing the SPAIRE and direct anterior (DA) approaches in femoral neck fracture (FNF) patients operated with hemiarthroplasty, and hypothesized equal changes in periprosthetic bone mineral density (BMD).</p><p><strong>Methods: </strong>From January 2022, eligible patients with a dislocated FNF were included in a RCT comparing the approaches (n = 158). Hypothesis and planned statistical tests were prespecified in this sub-group analysis, and 49 patients were examined by dual energy x-ray absorptiometry and followed for one year.</p><p><strong>Results: </strong>Both groups displayed a reduction in BMD from baseline to final follow-up. Mean BMD was -1.8% (95% CI -3 to 0.6) at three months and -0.5% (95% CI -1.2 to 0.2) at 12 months. In the SPAIRE group, total BMD decreased by 1.2% (95% CI -2.7 to 0.3) compared with 2.3% (95% CI -4.3 to -0.4) in the DA group at three months. At 12 months, total BMD increased by 0.2% (95% CI -0.9 to 1.2) in the SPAIRE group compared with a reduction of 1.2 (95% CI -2.3 to -0.1) in the DA group. Non-significant changes in Gruen zones 1 to 6 were found at three and 12 months. There was bone loss in Gruen zone 7 at 12 months in favour of the SPAIRE approach.</p><p><strong>Conclusion: </strong>There were substantially insignificant differences in periprosthetic BMD changes between the groups at baseline, three, and 12 months. The results indicate that SPAIRE and DA approaches affect periprosthetic BMD equally, and the approaches do not seem to have an unequal periprosthetic fracture risk.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 4","pages":"398-405"},"PeriodicalIF":2.8,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Augmented reality hip navigation system versus the Naviswiss system in cup alignment during total hip arthroplasty using the posterolateral approach.
IF 2.8
Bone & Joint Open Pub Date : 2025-04-03 DOI: 10.1302/2633-1462.64.BJO-2024-0148.R1
Koji Katoh, Katsuhiro Lee
{"title":"Augmented reality hip navigation system versus the Naviswiss system in cup alignment during total hip arthroplasty using the posterolateral approach.","authors":"Koji Katoh, Katsuhiro Lee","doi":"10.1302/2633-1462.64.BJO-2024-0148.R1","DOIUrl":"10.1302/2633-1462.64.BJO-2024-0148.R1","url":null,"abstract":"<p><strong>Aims: </strong>No studies have compared two portable navigation systems, including augmented reality (AR) hip navigation and the Naviswiss system, to improve the accuracy of acetabular component alignment during total hip arthroplasty (THA) in the posterolateral approach. We investigated the difference in cup placement accuracy between the two systems.</p><p><strong>Methods: </strong>We retrospectively compared THAs performed using the AR hip navigation (n = 32) and those performed using Naviswiss (n = 41) from June 2021 to April 2023. All patients underwent THA in the posterolateral approach. The primary endpoint includes radiological inclination (RI) and radiological anteversion (RA) measured on postoperative radiographs, and the absolute value error of radiological inclination (δRI) and radiological anteversion (δRA) between the final cup alignment displayed on the navigation screen at final cup fixation and cup alignment measured on postoperative radiographs.</p><p><strong>Results: </strong>No significant differences in the mean RI and mean rRA and δRI and δRA were found between the two groups. The percentage of cases with both δRI and δRA of < 3° were 31% and 24% in the AR hip and Naviswiss groups, respectively, with no significant difference. The percentage of cases in both δRI and δRA of < 5° was 66% and 90% in the AR hip and Naviswiss groups, respectively (p = 0.009). No cases demonstrated both δRI and δRA of > 5°.</p><p><strong>Conclusion: </strong>No significant differences were found between the two systems. The Naviswiss system demonstrated a higher percentage of errors within 5° than the AR navigation system, indicating that Naviswiss reproduced functional pelvic plane more accurately.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 4","pages":"391-397"},"PeriodicalIF":2.8,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11964670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The World Hip Trauma Evaluation (WHiTE) platform trial: a framework for randomized comparisons of interventions for fragility hip fracture.
IF 2.8
Bone & Joint Open Pub Date : 2025-04-02 DOI: 10.1302/2633-1462.64.BJO-2024-0240
Matthew L Costa, Juul Achten, Duncan Appelbe, Amrita Athwal, Richard Grant, Jonathan Cook, Rafael Pinedo-Villanueva, Stavros Petrou, Xavier L Griffin
{"title":"The World Hip Trauma Evaluation (WHiTE) platform trial: a framework for randomized comparisons of interventions for fragility hip fracture.","authors":"Matthew L Costa, Juul Achten, Duncan Appelbe, Amrita Athwal, Richard Grant, Jonathan Cook, Rafael Pinedo-Villanueva, Stavros Petrou, Xavier L Griffin","doi":"10.1302/2633-1462.64.BJO-2024-0240","DOIUrl":"10.1302/2633-1462.64.BJO-2024-0240","url":null,"abstract":"<p><strong>Aims: </strong>Hip fracture is one of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050. This protocol describes a platform trial framework, designed to efficiently deliver multiple randomized comparisons of interventions for patients with a fragility hip fracture.</p><p><strong>Methods: </strong>All patients aged 60 years and over with a hip fracture presenting to the World Hip Trauma Evaluation (WHiTE) recruitment centres will be considered for eligibility for each of the randomized comparisons appended to the platform at the time of recruitment. They will be offered the opportunity to take part in any or all of the randomized comparisons for which they are eligible. Comparisons may be contemporaneous or distributed throughout the treatment pathway. This master protocol describes the trial procedures, core dataset, and documentation. It describes those components of the research process which will be consistent between randomized comparisons. Where additional procedures are planned, specific to a randomized comparison, these will be described in a separate appendix protocol for that randomized comparison.</p><p><strong>Conclusion: </strong>The WHiTE platform trial will provide randomized evidence regarding the clinical and cost-effectiveness of interventions to improve outcomes for patients with fragility hip fracture. Findings will inform national and international policy and practice guidelines for the management of patients with a hip fracture.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 4","pages":"383-390"},"PeriodicalIF":2.8,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11961268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143765311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hip fractures: femoral neck versus trochanteric fractures, baseline characteristics and clinical outcomes.
IF 2.8
Bone & Joint Open Pub Date : 2025-04-01 DOI: 10.1302/2633-1462.64.BJO-2024-0203.R1
Eveline de Haan, Benthe van Oosten, Veronique A J I M van Rijckevorsel, Martijn Kuijper, Louis de Jong, Gert Roukema
{"title":"Hip fractures: femoral neck versus trochanteric fractures, baseline characteristics and clinical outcomes.","authors":"Eveline de Haan, Benthe van Oosten, Veronique A J I M van Rijckevorsel, Martijn Kuijper, Louis de Jong, Gert Roukema","doi":"10.1302/2633-1462.64.BJO-2024-0203.R1","DOIUrl":"10.1302/2633-1462.64.BJO-2024-0203.R1","url":null,"abstract":"<p><strong>Aims: </strong>The aim of this study was to assess differences in the clinical profile and baseline characteristics between patients with femoral neck fracture (FNF) and trochanteric fracture (TF). The secondary aim was to explore potential differences in clinical outcomes and mortality.</p><p><strong>Methods: </strong>A prospective hip fracture database (FAMMI) was used to obtain data for this observational cohort study. Patients with hip fracture surgery between January 2018 and February 2021 who were aged older than 70 years were prospectively included. Differences between patients with FNF and TF were evaluated by univariable logistic regression. A multivariable analysis was performed to analyze the relationship between type of fracture and mortality, adjusting for potential confounders.</p><p><strong>Results: </strong>In total, 2,089 patients were analyzed, of whom 1,233 (59%) had FNF and 856 (41%) had TF. Patients with TF were older, more often female, had a higher rate of chronic obstructive pulmonary disease and dementia, and had a lower Katz Index of Independence in activities of daily living score. Patients with TF had a lower rate of clinical complications such as delirium, pneumonia, reoperation, or wound infections. No differences in 30-day and one-year mortality were observed, also after multivariable correction.</p><p><strong>Conclusion: </strong>Based on this study, elderly patients with TF exhibit a comparatively inferior baseline status in comparison to patients with FNF. However, patients with TF have lower incidence of postoperative complications. No differences in 30-day and one-year mortality rates were observed between patients with the two types of proximal femoral fractures.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 4","pages":"373-382"},"PeriodicalIF":2.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11957847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of safety and efficacy of multiple intravenous and intraosseous doses of foetal liver-derived mesenchymal stem cells in children with severe osteogenesis imperfecta : the BOOST2B clinical trial protocol.
IF 2.8
Bone & Joint Open Pub Date : 2025-03-24 DOI: 10.1302/2633-1462.63.BJO-2024-0115.R1
Vrisha Madhuri, Sowmya Ramesh, Annika Goos, Thomas V Paul, Shyamkumar Nidugala Kesava, Vikram Mathews, Lilian Walther-Jallow, Cecilia Götherström, Åsa Ekblad, Vignesh Kumar, Suhasini Ganesh, Lakshmi Loganathan, Renita Raymond, Ashis Kumar, Dolly Daniel, Nihal Thomas, Deeptiman James, Madhavi Kandagaddala, Priya Mammen, Antonisamy B, Alok Srivastava
{"title":"Evaluation of safety and efficacy of multiple intravenous and intraosseous doses of foetal liver-derived mesenchymal stem cells in children with severe osteogenesis imperfecta : the BOOST2B clinical trial protocol.","authors":"Vrisha Madhuri, Sowmya Ramesh, Annika Goos, Thomas V Paul, Shyamkumar Nidugala Kesava, Vikram Mathews, Lilian Walther-Jallow, Cecilia Götherström, Åsa Ekblad, Vignesh Kumar, Suhasini Ganesh, Lakshmi Loganathan, Renita Raymond, Ashis Kumar, Dolly Daniel, Nihal Thomas, Deeptiman James, Madhavi Kandagaddala, Priya Mammen, Antonisamy B, Alok Srivastava","doi":"10.1302/2633-1462.63.BJO-2024-0115.R1","DOIUrl":"10.1302/2633-1462.63.BJO-2024-0115.R1","url":null,"abstract":"<p><strong>Aims: </strong>Current off-label bisphosphonate treatment for osteogenesis imperfecta (OI) does not induce healthy bone formation. Therefore, novel strategies to stimulate osteogenesis and reduce fractures are needed to meet the medical needs of these patients. Preclinical data and case studies show that multiple intravenous (IV) administrations of mesenchymal stem cells (MSCs) provide promising outcomes in the treatment of OI. In the Boost to Brittle Bones (BOOST2B) trial, we aim to assess the safety and tolerability of multiple IV and intraosseous (IO) administrations of foetal liver-derived MSCs in children aged one to five years diagnosed with severe OI.</p><p><strong>Methods: </strong>A total of 15 children will receive four doses of foetal MSCs IV (3 × 10<sup>6</sup> cells per kg of body weight) and IO (0.1 × 10<sup>6</sup> cells per kg of body weight per long bone) at four-month intervals. As a secondary endpoint, the therapeutic effect of the four MSC doses will be assessed based on the annual fracture rate, time to first fracture, bone mineral density, growth, clinical status of OI, and biochemical bone turnover in peripheral blood. Exploratory parameters include quality of life and donor cell engraftment.</p><p><strong>Conclusion: </strong>The BOOST2B trial has been approved by the regulatory agencies in India and is ongoing. It is the first clinical trial designed to evaluate IO administration of MSCs as a potential therapy for OI. Here, we describe the BOOST2B clinical trial protocol. The long-term data on safety and efficacy will be reported once completed.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 3","pages":"361-372"},"PeriodicalIF":2.8,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Statistical analysis plan for the Robotic-Assisted Surgery and Kinematic ALignment in total knee arthroplasty (RASKAL) registry-nested randomized trial. 机器人辅助手术和全膝关节置换术(RASKAL)登记嵌套随机试验的统计分析计划。
IF 2.8
Bone & Joint Open Pub Date : 2025-03-19 DOI: 10.1302/2633-1462.63.BJO-2024-0206
Samuel J MacDessi, Gregory C Wernecke, Durga Bastiras, Khashayar Ghadirinejad, Dylan Harries, Kara Cashman, Emma Heath, Michelle Lorimer, Carl Holder, Ian A Harris
{"title":"Statistical analysis plan for the Robotic-Assisted Surgery and Kinematic ALignment in total knee arthroplasty (RASKAL) registry-nested randomized trial.","authors":"Samuel J MacDessi, Gregory C Wernecke, Durga Bastiras, Khashayar Ghadirinejad, Dylan Harries, Kara Cashman, Emma Heath, Michelle Lorimer, Carl Holder, Ian A Harris","doi":"10.1302/2633-1462.63.BJO-2024-0206","DOIUrl":"10.1302/2633-1462.63.BJO-2024-0206","url":null,"abstract":"<p><strong>Aims: </strong>There is uncertainty over whether robotic-assisted surgery (RAS) or kinematic alignment (KA) improves outcomes in total knee arthroplasty (TKA). The Robotic-Assisted Surgery and Kinematic ALignment in TKA trial (RASKAL) is a registry-nested, multicentre, randomized, blinded, 2 × 2 factorial trial involving approximately 300 TKA patients. RASKAL will assess the effectiveness of RAS, KA, or both to improve clinical, operative, functional, radiological, and survivorship outcomes when compared to computer-assisted surgery (CAS) and mechanical alignment (MA), respectively. We describe the statistical analysis plan (SAP) for the RASKAL trial to ensure transparency of this study. Our purpose is to minimize analysis bias to bolster the internal validity of our findings.</p><p><strong>Methods: </strong>We created a SAP for the RASKAL trial to define the analysis of primary and secondary outcomes. The SAP will also state our approach to protocol deviations, withdrawals, management of missing data, and any loss to follow-up. General statistical analysis principles are outlined for the main outcomes, along with statistical tests required for each outcome.</p><p><strong>Conclusion: </strong>The RASKAL SAP pre-specifies the statistical plan for the primary outcome of knee-specific function using the Knee injury and Osteoarthritis Outcome Score-12 comparing RAS to CAS and KA to MA up to one year postoperatively. The primary outcome will be reported as a modified intention-to-treat analysis, with secondary per-protocol analyses. Secondary outcomes will include other patient-reported outcome measures, early recovery, operative outcomes, functional outcomes, radiological precision, prosthetic survivorship, and cost-effectiveness analyses.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 3","pages":"352-360"},"PeriodicalIF":2.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11919467/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Salunke's GCRI surgical technique for neopatellar ligament reconstruction using hamstring tendon in proximal tibia tumour megaprosthesis.
IF 2.8
Bone & Joint Open Pub Date : 2025-03-14 DOI: 10.1302/2633-1462.63.BJO-2024-0230.R1
Abhijeet A Salunke, Nandlal Bharwani, Dhruv Patel, Mutthu Varun, Keval Patel, Vikas Warikoo, Mohit Sharma, Shashank Pandya
{"title":"Salunke's GCRI surgical technique for neopatellar ligament reconstruction using hamstring tendon in proximal tibia tumour megaprosthesis.","authors":"Abhijeet A Salunke, Nandlal Bharwani, Dhruv Patel, Mutthu Varun, Keval Patel, Vikas Warikoo, Mohit Sharma, Shashank Pandya","doi":"10.1302/2633-1462.63.BJO-2024-0230.R1","DOIUrl":"10.1302/2633-1462.63.BJO-2024-0230.R1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Aims: &lt;/strong&gt;Reconstruction of soft tissues and preservation of the extensor mechanism integrity provide a major challenge following resection of the proximal tibia tumours. We propose a novel surgical technique for neopatellar ligament reconstruction using hamstring tendon in proximal tibia tumour cases. This study details the surgical technique, early clinical and radiological outcomes, and the potential long-term benefits of this innovative reconstructive approach following proximal tibia megaprosthesis implantation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study included 15 patients with proximal tibia tumours treated at orthopaedic oncology unit in Gujarat Cancer and Research Institue (GCRI), Ahmedabad, India. Surgical procedures included resecting the proximal tibia tumour, implanting a megaprosthesis, and using hamstring tendons to reconstruct the extensor mechanism by the neopatellar ligament. Autologous hamstring tendons (gracilis and semitendinosus) harvested from the ipsilateral leg were used and these tendons were braided together with a nonabsorbable suture and threaded through the remaining patellar tendon. The braided tendons were then secured to the holes in the tibial tuberosity of the proximal tibia megaprosthesis implant XLO (Ortho Life Systems, India) using nonabsorbable fibre wire sutures FiberWire (Arthrex, USA). The tension in the tendons was optimized and the sutures were tightened with the knee in full extension and the implant with neopatellar ligament were covered by medial gastrocnemius muscle flap. The mean follow-up period was 19 months (13 to 24), the mean age of the study group was 24.6 years (14 to 44), and it included 11 males and four females.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The histopathological diagnosis was osteosarcoma (eight patients), Ewing's sarcoma (four patients), and giant cell tumours (three patients). The mean surgical duration was 3.2 hours (2.5 to 4.2) and the mean blood loss was 250 ml (150 to 450).Wound infection was found in three cases, which was managed with debridement and antibiotics. None of the patients had a local recurrence at the latest follow-up. The mean active knee flexion was 92° (85° to 105°), with an extensor lag of 4.6° (0° to 10°). The mean patella height preoperatively was 4.5 cm (4.3 to 5.1), with a patella tendon length of 4.7 cm (4.3 to 5.68). The mean preoperative patella height-to-patella tendon length ratio was 0.96 (0.89 to 1.02). Postoperatively (at 12 months), the mean patella tendon length was 4.4 cm (4.1 to 5.1), with a patella height-to- patella tendon length ratio of 1.04 (1 to 1.14). Follow-up radiological examinations showed that the neopatellar tendon had integrated satisfactorily, with no obvious signs of graft rupture or elongation.The mean Musculoskeletal Tumor Society score was 24 (22 to 27).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This study presents Salunke's Gujarat Cancer and Research Institute (GCRI) novel approach using hamstring tendons for neopat","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 3","pages":"342-351"},"PeriodicalIF":2.8,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11906219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving Consent in Trauma: Recall (ICIT: Recall) : a multicentre study protocol of consent for hip fractures.
IF 2.8
Bone & Joint Open Pub Date : 2025-03-13 DOI: 10.1302/2633-1462.63.BJO-2024-0190
Tony Feng, Andrew Ablett, Chloe E H Scott, Nick D Clement
{"title":"Improving Consent in Trauma: Recall (ICIT: Recall) : a multicentre study protocol of consent for hip fractures.","authors":"Tony Feng, Andrew Ablett, Chloe E H Scott, Nick D Clement","doi":"10.1302/2633-1462.63.BJO-2024-0190","DOIUrl":"10.1302/2633-1462.63.BJO-2024-0190","url":null,"abstract":"<p><strong>Aims: </strong>This study investigates the effectiveness and adequacy of the informed consent process for patients undergoing hip fracture surgery. While informed consent is a legal and ethical responsibility, factors in the trauma setting can impair patients' understanding and retention of information. This study seeks to evaluate patients' recall of perioperative complications and explore their perceptions of the consent process.</p><p><strong>Methods: </strong>A mixed-methods, multicentre cohort study will be conducted in the Southeast of Scotland. Adult patients with hip fractures will be recruited via purposive sampling. An information recall questionnaire will be administered within 36 hours of admission to assess unprompted and prompted recall of complications. A subset of participants will then undergo a semi-structured qualitative interview postoperatively to explore their experiences and perceptions of the consent process. Data will be analyzed using a social constructivist grounded theory to assess their perceptions of consent. Ethical approval has been granted by the East of England Research Ethics Committee (reference 23/EE/0233).</p><p><strong>Conclusion: </strong>Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. The study results will identify challenges in the consent process, particularly in how risks are communicated and understood. The data are expected to inform the development of information aids and enhance the ability of orthopaedic surgeons to provide comprehensive, patient-centred consent.</p>","PeriodicalId":34103,"journal":{"name":"Bone & Joint Open","volume":"6 3","pages":"336-341"},"PeriodicalIF":2.8,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956774/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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