Aims. Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon. Methods. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments. Discussion. There is currently no high-quality evidence comparing the clinical and cost effectiveness of the tension suture repair to the traditional tension band wiring currently offered for the internal fixation of displaced fractures of the olecranon. The Simple Olecranon Fracture Fixation Trial (SOFFT) is a randomized controlled trial with sufficient power and design rigour to provide this evidence for the subtype of Mayo grade IIA fractures. Cite this article: Bone Jt Open 2023;4(1):27–37

Background. Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. Design. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset. Discussion. Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimum treatment will improve patient outcomes and have important health economic implications. Cite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation – WH. I. TE 3: HEMI – An Abridged Protocol. Bone Joint Res 2016;5:18–25. doi: 10.1302/2046-3758.51.2000473

Musculoskeletal diseases are having a growing impact worldwide. It is therefore crucial to have an evidence base to most effectively and efficiently implement future health services across different healthcare systems. International trials are an opportunity to address these challenges and have many potential benefits. They are, however, complex to set up and deliver, which may impact on the efficient and timely delivery of a project. There are a number of models of how international trials are currently being delivered across a range of orthopaedic patient populations, which are discussed here. The examples given highlight that the key to overcoming these challenges is the development of trusted and equal partnerships with collaborators in each country. International trials have the potential to address a global burden of disease, and in turn optimize the benefit to patients in the collaborating countries and those with similar health services and care systems. Cite this article: Bone Joint J 2023;105-B(7):719–722

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article: Bone Joint J 2024;106-B(2):114–120

Aims. Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments. Methods. This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model. Results. The proportion of respondents (surgeons n = 103; patients n = 140) who would not participate in any of the DCE choice sets (surgeons = 31%; patients = 40%), and the proportion who would participate in all (surgeons = 18%; patients = 30%), indicated strong views regarding the conduct of RCT-Ps. There were three main findings: for both surgeons and patients, studies which involved an arthroscopic procedure were more likely to result in participation than those with a total knee arthroplasty; as the age (for patients) and years of experience (for surgeons) increased, the overall likelihood of participation decreased; and, for surgeons, offering authorship and input into the RCT-P design was preferred for less experienced surgeons, while only completing the procedure was preferred by more experienced surgeons. Conclusion. Patients and surgeons have strong views regarding participation in RCT-Ps. However, understanding their preferences can inform future trial designs and feasibility assessments with regard to recruitment rates. Cite this article: Bone Joint J 2024;106-B(12):1408–1415

Aims. Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. Methods. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral. Results. We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research. Conclusion. We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder. Cite this article: Bone Jt Open 2024;5(3):162–173

Aims. Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. Methods. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately. Conclusion. This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results. Cite this article: Bone Joint Open 2020;1-6:205–213

Aims. Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery. Methods. Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, or ‘no information’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews. Results. We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 61 (6.7%) were inadequate, 410 (44.7%) lacked information, and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT. Conclusion. There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs. Cite this article: Bone Jt Open 2024;5(12):1072–1080

Aims. To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment. Methods. Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments. Results. Between December 2017 and December 2019, 60 patients were recruited (median age 77.4 years, range 63.3 to 88.5) (39/21 M/F ratio). At final nine-month follow-up, 4/60 (7%) had withdrawn, 4/60 (7%) had died, and one had been lost to follow-up; a 98% response rate (50/51) was achieved for the EQ-5D questionnaire. Four deaths were recorded during the three-year trial period: three in the non-surgical treatment group and one in the fix-and-replace group. Conclusion. This study has shown a full-scale RCT to be feasible, but will need international recruitment. The Acetabular Fractures in older patients Intervention Trial (AceFIT) has informed the design of a multinational RCT sample size of 1,474 or 1,974 patients for a minimal clinically important difference of 0.06 on EQ-5D, with a power of 0.8 or 0.9, and loss to follow-up of 20%. This observed patient cohort comprises a medically complex group requiring multidisciplinary care; surgeon, anaesthetist, and ortho-geriatrician input is needed to optimize recovery and rehabilitation. Cite this article: Bone Joint J 2024;106-B(4):401–411

Aims. Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. Methods. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. Discussion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England – Cambridge Central Research Ethics Committee. Publication is anticipated to occur in 2024. Cite this article: Bone Jt Open 2024;5(4):343–349

Aims. To explore key stakeholder views around feasibility and acceptability of trials seeking to prevent post-traumatic osteoarthritis (PTOA) following knee injury, and provide guidance for next steps in PTOA trial design. Methods. Healthcare professionals, clinicians, and/or researchers (HCP/Rs) were surveyed, and the data were presented at a congress workshop. A second and related survey was then developed for people with joint damage caused by knee injury and/or osteoarthritis (PJDs), who were approached by a UK Charity newsletter or Oxford involvement registry. Anonymized data were collected and analyzed in Qualtrics. Results. Survey responses (n = 19 HCP/Rs, 39 PJDs) supported studies testing pharmacological agents preventing PTOA. All HCP/Rs and 30/31 (97%) PJDs supported the development of new treatments that improved or delayed knee symptoms and damage to knee structure. PJDs thought that improving structural knee damage was more important than knee symptoms. Both groups found studies more acceptable as expected future benefit and risk of PTOA increased. All drug delivery routes were acceptable. Workshop participants (around n = 60) reflected survey views. Discussions suggested that stratifying using molecular testing for likely drug response appeared to be more acceptable than using characteristics such as sex, age, and BMI. Conclusion. Our findings supported PTOA drug intervention studies, including situations where there is low risk of disease, no expected benefit of treatment, and frequent treatment administration. PJDs appeared less risk-averse than HCP/Rs. This work reinforces the benefits of consensus and involvement work in the co-creation of PTOA drug trial design. Involvement of key stakeholders, such as PJDs with different risks of OA and regulatory representatives, are critical for trial design success. Cite this article: Bone Joint Res 2024;13(9):513–524

Aims. Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(5):411–418

Aims. Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. Methods. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after a subacromial space steroid injection between the anterolateral versus posterior approach in patients with subacromial pain syndrome. This will help to guide treatment for patients with subacromial pain syndrome. Cite this article: Bone Jt Open 2024;5(9):729–735

Aims. During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. Methods. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group. Conclusion. The trial findings will provide evidence about the clinical and cost-effectiveness of always patellar resurfacing compared to selective patellar resurfacing. This will inform future NICE guidelines on primary TKR and the role of selective patellar resurfacing. Cite this article: Bone Jt Open 2024;5(6):464–478

Aims. To analyze outcomes reported in trials of childhood fractures. Methods. OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classification of Function framework. Results. In all, 525 outcomes were identified representing 52 WHO domains. Four domains were reported in more than 50% of trials: structure of upper/lower limb, sensation of pain, mobility of joint function, and health services, systems and policies. The Activities Scale for Kids performance (ASK-p) score was the most common outcome score reported in 6/72 upper limb and 4/28 lower limb trials. Conclusion. There is a diverse range of outcomes reported in trials of childhood fractures covering all areas in the International Classification of Functioning, Disability and Health (ICF) framework. There were three common upper limb and three common lower limb outcomes. In the absence of a core outcome set, we recommend that upper limb trials report pain, range of movement and radiograph appearance of the arm and lower limb trials report pain, radiograph appearance of the leg and healthcare costs to improve consistency of reporting in future trials. Cite this article: Bone Joint Open 2020;1-5:167–174

Aims. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA). Methods. This study is a secondary analysis of patients aged 50 years or older with a displaced femoral neck fracture who were enrolled in the HEALTH trial and underwent monopolar and bipolar HA. Scores from the Western Ontario and McMaster University Arthritis Index (WOMAC) and 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) and (MCS) were compared between the two HA groups using a propensity score-weighted analysis. Results. Of 746 HAs performed in the HEALTH trial, 404 were bipolar prostheses and 342 were unipolar. After propensity score weighting, adequate balance between the bipolar and unipolar groups was obtained as shown by standardized mean differences less than 0.1 for each covariable. A total of 24 months after HA, the total WOMAC score and its subcomponents showed no statistically significant difference between the unipolar and bipolar groups. Similarly, no statistically significant difference was found in the PCS and MCS scores of the SF-12 questionnaire. In participants aged 70 years and younger, no difference was found in any of the functional outcomes. Conclusion. From the results of this study, the use of bipolar HA over unipolar design does not provide superior functional outcomes at 24 months postoperatively. The theoretical advantage of reduced acetabular wear with bipolar designs does not appear to influence functional outcomes in the first two years postoperatively. Cite this article: Bone Jt Open 2023;4(5):370–377

Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637

Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579

Aims. To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials. Methods. This study included 2,388 patients from the HEALTH and FAITH trials, with 90-day and one-year mortality proportions of 3.0% (71/2,388) and 6.4% (153/2,388), respectively. The mean age was 75.9 years (SD 10.8) and 65.9% of patients (1,574/2,388) were female. The algorithms included patient and injury characteristics. Six algorithms were developed, internally validated and evaluated across discrimination (c-statistic; discriminative ability between those with risk of mortality and those without), calibration (observed outcome compared to the predicted probability), and the Brier score (composite of discrimination and calibration). Results. The developed algorithms distinguished between patients at high and low risk for 90-day and one-year mortality. The penalized logistic regression algorithm had the best performance metrics for both 90-day (c-statistic 0.80, calibration slope 0.95, calibration intercept -0.06, and Brier score 0.039) and one-year (c-statistic 0.76, calibration slope 0.86, calibration intercept -0.20, and Brier score 0.074) mortality prediction in the hold-out set. Conclusion. Using high-quality data, the ML-based prediction models accurately predicted 90-day and one-year mortality in patients aged 50 years or older with a FNF. The final models must be externally validated to assess generalizability to other populations, and prospectively evaluated in the process of shared decision-making. Cite this article: Bone Jt Open 2023;4(3):168–181

Aims. The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial. Methods. The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded. Results. A total of 1,015 of the original patients (66%) provided at least one set of outcome data during the five years of follow-up. There was no evidence of a difference in patient-reported disability between the two groups at five years (NPWT group mean DRI 30.0 (SD 26.5), standard dressing group mean DRI 31.5 (SD 28.8), adjusted difference -0.86 (95% CI -4.14 to 2.40; p = 0.609). There was also no evidence of a difference in the complication rates at this time. Conclusion. We found no evidence of a difference in disability ratings between NPWT compared with standard wound dressings in the five years following the surgical treatment of a complex fracture of the lower limb. Patients in both groups reported high levels of persistent disability and reduced quality of life, with little evidence of improvement during this time. Cite this article: Bone Joint J 2024;106-B(8):858–864

Aims. Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. Methods. This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation. Conclusion. This study will assess whether supervised rehabilitation is more effective than self-directed rehabilitation for adults aged 50 years and older after ankle fracture. The results will provide evidence to guide clinical practice. At the time of submission, the trial is currently completing recruitment, and follow-up will be completed in 2024. Cite this article: Bone Jt Open 2024;5(6):499–513

Aims. To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. Methods. A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. Results. The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes: the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident; an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills; and treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment. Conclusion. Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity, and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice. Cite this article: Bone Jt Open 2021;2(7):486–492

Aims. The aim of this study was to evaluate the healthcare costs and benefits of enoxaparin compared to aspirin in the prevention of symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) using data from the CRISTAL trial. Methods. This trial-based economic analysis reports value for money as incremental cost per quality-adjusted life-year (QALY) gained in 2022 Australian dollars, compared to a single threshold value of AUD$70,000 per QALY. Event costs were estimated based on occurrence of VTEs and bleeds, and on published guidelines for treatment. Unit costs were taken from Australian sources. QALYs were estimated using CRISTAL six-month follow-up data. Sensitivity analyses are presented that vary the cost of VTE treatment, and extend the analyses to two years. Results. The CRISTAL trial found that enoxaparin was more effective than aspirin in preventing symptomatic VTE within 90 days of THA or TKA (risk difference 1.97% (95% confidence interval (CI) 0.54% to 3.41%; p = 0.007)). The additional cost after a THA or TKA was AUD$83 (95% CI 68 to 97) for enoxaparin, and enoxaparin resulted in an additional 0.002 QALYs (95% CI -0.002 to 0.005). Incremental cost per QALY gained was AUD$50,567 (95% CI 15,513, dominated) for enoxaparin. We can be 60% confident that the incremental cost per QALY does not exceed the willingness-to-pay threshold of AUD$70,000. Increasing the cost of VTE treatment and extension of costs and consequences to two years suggested greater confidence that enoxaparin is good value for money (70% and 63% confidence, respectively). Conclusion. This analysis provides strong evidence that enoxaparin thromboprophylaxis following THA or TKA reduced VTEs, but weak evidence of net economic benefits over aspirin. If the value of avoiding VTEs is high, and there is a strong likelihood of VTE-related health impairments, we can be more confident that enoxaparin is cost-effective compared to aspirin. Cite this article: Bone Joint J 2024;106-B(6):589–595

The Ankle Injury Management (AIM) trial was a pragmatic equivalence randomized controlled trial conducted at 24 hospitals in the United Kingdom that recruited 620 patients aged more than 60 years with an unstable ankle fracture. The trial compared the usual care pathway of early management with open reduction and internal fixation with initially attempting non-surgical management using close contact casting (CCC). CCC is a minimally padded cast applied by an orthopaedic surgeon after closed reduction in the operating theatre. The intervention groups had equivalent functional outcomes at six months and longer-term follow-up. However, potential barriers to using CCC as an initial form of treatment for these patients have been identified. In this report, the results of the AIM trial are summarized and the key issues are discussed in order to further the debate about the role of CCC. Evidence from the AIM trial supports surgeons considering conservative management by CCC as a treatment option for these patients. The longer-term follow-up emphasized that patients treated with CCC need careful monitoring in the weeks after its application to monitor maintenance of reduction. Cite this article: Bone Joint J 2019;101-B:1472–1475

Aims. To analyze the short-term outcome of two types of total wrist arthroplasty (TWA) in terms of wrist function, migration, and periprosthetic bone behaviour. Methods. A total of 40 patients suffering from non-rheumatoid wrist arthritis were enrolled in a randomized controlled trial comparing the ReMotion and Motec TWAs. Patient-rated and functional outcomes, radiological changes, blood metal ion levels, migration measured by model-based radiostereometric analysis (RSA), bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), complications, loosening, and revision rates at two years were compared. Results. Patient-Rated Wrist and Hand Evaluation (PRWHE) scores, abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) scores, and pain improved similarly and significantly in both groups. Wrist motion improved significantly in the Motec group only, and forearm rotation in the ReMotion group only. Cobalt (Co) and chromium (Cr) blood ion levels were significantly higher in the metal-on-metal (MoM) Motec group than in the metal-on-polyethylene (MoP) ReMotion group. Mean total translation was 0.65 mm (95% confidence interval (CI) 0.26 to 1.12) and 0.27 mm (95% CI 0.14 to 0.47) for the ReMotion carpal and radial components, and 0.32 mm (95% CI 0.22 to 0.45) and 0.26 mm (95% CI 0.20 to 0.34) for the Motec metacarpal and radial components, respectively. Apart from dorsal and volar tilts, which were significantly higher for the radial ReMotion than for the Motec component, no significant differences in absolute migration occurred. BMD around the radial components never returned to baseline. Almost one-third of patients required reoperation due to complications. Two ReMotion implants were revised to Motec TWAs due to carpal component loosening, and three Motec MoM articulations were revised to metal-on-polyether ether ketone due to painful synovitis. Conclusion. Both implants provided matched function and were stable at short-term follow-up, but with a high complication rate. This procedure should be restricted to specialist centres undertaking prospective analysis until its role is clarified. Cite this article: Bone Joint J 2022;104-B(10):1132–1141

Aims. The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy. Methods. Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions. Results. A total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period. Conclusion. Our study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented. Cite this article: Bone Jt Open 2024;5(7):534–542

Aims. Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care. Methods. This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment. Anticipated impact. The 12-month results will be presented and published internationally. This is anticipated to be the only pragmatic trial reporting outcomes comparing surgical with non-surgical treatment in unstable ankle fractures in younger adults (aged 60 years and younger), and, as such, will inform the National Institute for Health and Care Excellence (NICE) ‘non-complex fracture’ recommendations at their scheduled update in 2024. A report of long-term outcomes at five years will be produced by January 2027. Cite this article: Bone Jt Open 2024;5(3):184–201

Aims. The aim of this study was to compare a bicruciate-retaining (BCR) total knee arthroplasty (TKA) with a posterior cruciate-retaining (CR) TKA design in terms of kinematics, measured using fluoroscopy and stability as micromotion using radiostereometric analysis (RSA). Methods. A total of 40 patients with end-stage osteoarthritis were included in this randomized controlled trial. All patients performed a step-up and lunge task in front of a monoplane fluoroscope one year postoperatively. Femorotibial contact point (CP) locations were determined at every flexion angle and compared between the groups. RSA images were taken at baseline, six weeks, three, six, 12, and 24 months postoperatively. Clinical and functional outcomes were compared postoperatively for two years. Results. The BCR-TKA demonstrated a kinematic pattern comparable to the natural knee’s screw-home mechanism in the step-up task. In the lunge task, the medial CP of the BCR-TKA was more anterior in the early flexion phase, while laterally the CP was more posterior during the entire movement cycle. The BCR-TKA group showed higher tibial migration. No differences were found for the clinical and functional outcomes. Conclusion. The BCR-TKA shows a different kinematic pattern in early flexion/late extension compared to the CR-TKA. The difference between both implants is mostly visible in the flexion phase in which the anterior cruciate ligament is effective; however, both designs fail to fully replicate the motion of a natural knee. The higher migration of the BCR-TKA was concerning and highlights the importance of longer follow-up. Cite this article: Bone Joint J 2023;105-B(1):35–46

Aims. The primary aim was to assess whether robotic total knee arthroplasty (rTKA) had a greater early knee-specific outcome when compared to manual TKA (mTKA). Secondary aims were to assess whether rTKA was associated with improved expectation fulfilment, health-related quality of life (HRQoL), and patient satisfaction when compared to mTKA. Methods. A randomized controlled trial was undertaken, and patients were randomized to either mTKA or rTKA. The primary objective was functional improvement at six months. Overall, 100 patients were randomized, 50 to each group, of whom 46 rTKA and 41 mTKA patients were available for review at six months following surgery. There were no differences between the two groups. Results. There was no difference between rTKA and mTKA groups at six months according to the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) functional score (mean difference (MD) 3.8 (95% confidence interval (CI) -5.6 to 13.1); p = 0.425). There was a greater improvement in the WOMAC pain score at two months (MD 9.5 (95% CI 0.6 to 18.3); p = 0.037) in the rTKA group, although by six months no significant difference was observed (MD 6.7 (95% CI -3.6 to 17.1); p = 0.198). The rTKA group were more likely to achieve a minimal important change in their WOMAC pain score when compared to the mTKA group at two months (n = 36 (78.3%) vs n = 24 (58.5%); p = 0.047) and at six months (n = 40 (87.0%) vs n = 29 (68.3%); p = 0.036). There was no difference in satisfaction between the rTKA group (97.8%; n = 45/46) and the mTKA group (87.8%; n = 36/41) at six months (p = 0.096). There were no differences in EuroQol five-dimension questionnaire (EQ-5D) utility gain (p ≥ 0.389) or fulfilment of patient expectation (p ≥ 0.054) between the groups. Conclusion. There were no statistically significant or clinically meaningful differences in the change in WOMAC function between mTKA and rTKA at six months. rTKA was associated with a higher likelihood of achieving a clinically important change in knee pain at two and six months, but no differences in knee-specific function, patient satisfaction, health-related quality of life, or expectation fulfilment were observed. Cite this article: Bone Joint J 2023;105-B(9):961–970

Aims. The gold standard for percutaneous Achilles tendon tenotomy during the Ponseti treatment for idiopathic clubfoot is a tenotomy with a No. 15 blade. This trial aims to establish the technique where the tenotomy is performed with a large-bore needle as noninferior to the gold standard. Methods. We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively. Results. The blade group had more dorsiflexion at both follow-up consultations: 18.36° versus 18.03° (p = 0.115) at three weeks and 18.96° versus 18.26° (p = 0.001) at three months. The difference of the mean at three months 0.7° is well below the noninferiority margin of 4°. There was no significant difference in Pirani scores. The blade group had more extensive scar marks at three months than the needle group (8 vs 2). No major complications were recorded. Conclusion. The needle tenotomy is noninferior to the blade tenotomy for usage in Ponseti treatment for idiopathic clubfoot in children aged below 36 months. Cite this article: Bone Joint J 2024;106-B(8):871–878

Aims. Paediatric fractures are highly prevalent and are most often treated with plaster. The application and removal of plaster is often an anxiety-inducing experience for children. Decreasing the anxiety level may improve the patients’ satisfaction and the quality of healthcare. Virtual reality (VR) has proven to effectively distract children and reduce their anxiety in other clinical settings, and it seems to have a similar effect during plaster treatment. This study aims to further investigate the effect of VR on the anxiety level of children with fractures who undergo plaster removal or replacement in the plaster room. Methods. A randomized controlled trial was conducted. A total of 255 patients were included, aged five to 17 years, who needed plaster treatment for a fracture of the upper or lower limb. Randomization was stratified for age (five to 11 and 12 to 17 years). The intervention group was distracted with VR goggles and headphones during the plaster treatment, whereas the control group received standard care. As the primary outcome, the post-procedural level of anxiety was measured with the Child Fear Scale (CFS). Secondary outcomes included the children’s anxiety reduction (difference between CFS after and CFS before plaster procedure), numerical rating scale (NRS) pain, NRS satisfaction of the children and accompanying parents/guardians, and the children’s heart rates during the procedure. An independent-samples t-test and Mann-Whitney U test (depending on the data distribution) were used to analyze the data. Results. The post-procedural CFS was significantly lower (p < 0.001) in the intervention group (proportion of children with no anxiety = 78.6%) than in the control group (56.8%). The anxiety reduction, NRS pain and satisfaction scores, and heart rates showed no significant differences between the control group and the intervention group. Subanalyses showed an increased effect of VR on anxiety levels in young patients, females, upper limb fractures, and those who had had previous plaster treatment. Conclusion. VR effectively reduces the anxiety levels of children in the plaster room, especially in young girls. No statistically significant effects were seen regarding pain, heart rate, or satisfaction scores. Cite this article: Bone Joint J 2024;106-B(7):728–734

Aims. Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). Methods. UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion. The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880

Aims. The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness. Methods. A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation. Results. At 18 months, patients in the surgical reconstruction arm reported higher QALYs (0.052 (95% confidence interval (CI) -0.012 to 0.117); p = 0.177) and higher NHS costs (£1,017 (95% CI 557 to 1,476); p < 0.001) compared to rehabilitation. This resulted in an ICER of £19,346 per QALY with the probability of surgical reconstruction being cost-effective of 51% and 72% at a willingness-to-pay threshold of £20,000 and £30,000 per QALY, respectively. Conclusion. Surgical reconstruction as a management strategy for patients with long-standing ACL injury is more effective, but more expensive, at 18 months compared to rehabilitation management. In the UK setting, surgical reconstruction is cost-effective. Cite this article: Bone Joint J 2024;106-B(1):38–45

Aims. This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme. Methods. A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed. Results. Overall, 130 participants returned their 12-week OMAS questionnaires. The mean OMAS was significantly higher in the EMADE group compared with the immobilized group (62.0 (SD 20.9) vs 48.8 (SD 22.5)), with a clinically meaningful mean difference of 13.2 (95% CI 5.66 to 20.73; p < 0.001). These differences were maintained at week 24, with convergence by week 52. No intervention-related adverse events, including instability, were reported. Conclusion. The EMADE programme demonstrated an accelerated recovery compared to traditional six-week cast immobilization for those who have undergone ORIF surgery to stabilize Weber B (AO44B) ankle fractures. The study found the EMADE intervention to be safe. Cite this article: Bone Joint J 2024;106-B(9):949–956

Aims. Achieving accurate implant positioning and restoring native hip biomechanics are key surgeon-controlled technical objectives in total hip arthroplasty (THA). The primary objective of this study was to compare the reproducibility of the planned preoperative centre of hip rotation (COR) in patients undergoing robotic arm-assisted THA versus conventional THA. Methods. This prospective randomized controlled trial (RCT) included 60 patients with symptomatic hip osteoarthritis undergoing conventional THA (CO THA) versus robotic arm-assisted THA (RO THA). Patients in both arms underwent pre- and postoperative CT scans, and a patient-specific plan was created using the robotic software. The COR, combined offset, acetabular orientation, and leg length discrepancy were measured on the pre- and postoperative CT scanogram at six weeks following surgery. Results. There were no significant differences for any of the baseline characteristics including spinopelvic mobility. The absolute error for achieving the planned horizontal COR was median 1.4 mm (interquartile range (IQR) 0.87 to 3.42) in RO THA versus 4.3 mm (IQR 3 to 6.8; p < 0.001); vertical COR mean 0.91 mm (SD 0.73) in RO THA versus 2.3 mm (SD 1.3; p < 0.001); and combined offset median 2 mm (IQR 0.97 to 5.45) in RO THA versus 3.9 mm (IQR 2 to 7.9; p = 0.019). Improved accuracy was observed with RO THA in achieving the desired acetabular component positioning (root mean square error for anteversion and inclination was 2.6 and 1.3 vs 8.9 and 5.3, repectively) and leg length (mean 0.6 mm vs 1.4 mm; p < 0.001). Patient-reported outcome measures were comparable between the two groups at baseline and one year. Participants in the RO THA group needed fewer physiotherapy sessions postoperatively (median six (IQR 4.5 to 8) vs eight (IQR 6 to 11; p = 0.005). Conclusion. This RCT suggested that robotic-arm assistance in THA was associated with improved accuracy in restoring the native COR, better preservation of the combined offset, leg length correction, and superior accuracy in achieving the desired acetabular component positioning. Further evaluation through long-term and registry data is necessary to assess whether these findings translate into improved implant survival and functional outcomes. Cite this article: Bone Joint J 2024;106-B(4):324–335

Aims. The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. Methods. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Results. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. Conclusion. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture. Cite this article: Bone Joint J 2023;105-B(4):382–388

Aims. Platelet-rich plasma (PRP) intra-articular injections may provide a simple and minimally invasive treatment for early-stage knee osteoarthritis (OA). This has led to an increase in its adoption as a treatment for knee OA, although there is uncertainty about its efficacy and benefit. We hypothesized that patients with early-stage symptomatic knee OA who receive multiple PRP injections will have better clinical outcomes than those receiving single PRP or placebo injections. Methods. A double-blinded, randomized placebo-controlled trial was performed with three groups receiving either placebo injections (Normal Saline), one PRP injection followed by two placebo injections, or three PRP injections. Each injection was given one week apart. Outcomes were prospectively collected prior to intervention and then at six weeks, three months, six months, and 12 months post-intervention. Primary outcome measures were Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol five-dimension five-level index (EQ-5D-5L). Secondary outcomes included visual analogue scale for pain and patient subjective assessment of the injections. Results. A total of 102 patients were recruited. The follow-up period was 12 months, at intervals of six weeks, 12 weeks, six months, and 12 months. KOOS-Total significantly improved in all groups at these time intervals compared to pre-injection. There was an improvement in EQ-5D-5L index scores in saline and single injection groups, but not in the multiple injection group. Comparison of treatment groups showed no additional beneficial effect of single or multiple PRP injections above that displayed in the saline injection group. Subjective patient satisfaction and recommendation of treatment received demonstrated a similar pattern in all the groups. There was no indication of superiority of either single or multiple PRP injections compared to saline injections. Conclusion. There is no evidence that single or multiple PRP had any additional beneficial effect compared to saline injection up to 12 months, follow-up after treatment of early stage symptomatic OA of the knee. Cite this article: Bone Joint J 2022;104-B(6):663–671

Aims. Tranexamic acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomized control trial (RCT) aimed to assess if an additional 24 hours of TXA postoperatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date, this trial included high-risk patients. This paper presents the results of a cost analysis undertaken alongside this RCT. Methods. TRAC-24 was a prospective RCT on patients undergoing TKA and THA. Three groups were included: Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour postoperative oral regime, Group 2 received only the perioperative dose, and Group 3 did not receive TXA. Cost analysis was performed out to day 90. Results. Group 1 was associated with the lowest mean total costs, followed by Group 2 and then Group 3. The differences between Groups 1 and 3 (-£797.77 (95% confidence interval -1,478.22 to -117.32) were statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in Groups 1 and 2 resulted from reduced length of stay, readmission rates, emergency department attendances, and blood transfusions. Conclusion. This study demonstrated significant cost savings when using TXA in primary THA or TKA. Extended oral dosing reduced costs further in THA but not TKA. Cite this article: Bone Jt Open 2022;3(7):536–542

Aims. Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance. Methods. We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs. Results. Overall, 139 ankle fractures were fixed by 28 postgraduate year three to five trainee surgeons (mean age 29.4 years; 71% males) during ten months' follow-up. Under the intention-to-treat principle, a technically superior fixation was performed by the cadaveric-trained group compared to the standard-trained group, as measured on the first postoperative radiograph against predefined acceptability thresholds. The cadaveric-trained group used a lower intraoperative dose of radiation than the standard-trained group (mean difference 0.011 Gym. 2. , 95% confidence interval 0.003 to 0.019; p = 0.009). There was no difference in procedure time. Conclusion. Trainees randomized to cadaveric training performed better ankle fracture fixations and irradiated patients less during surgery compared to standard-trained trainees. This effect, which was previously unknown, is likely to be a consequence of the intervention. Further study is required. Cite this article: Bone Jt Open 2023;4(8):594–601

Aims. Nearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion. Methods. The aim of the study is to compare navigated kinematically aligned TKAs (KA TKAs) with navigated mechanically aligned TKA (MA TKA) in terms of function and ROM. We aim to recruit a total of 96 patients in the trial. The patients will be recruited from clinics of various consultants working in the trust after screening them for eligibility criteria and obtaining their informed consent to participate in this study. Randomization will be done prior to surgery by a software. The primary outcome measure will be the Knee injury and Osteoarthritis Outcome Score The secondary outcome measures include Oxford Knee Score, ROM, EuroQol five-dimension questionnaire, EuroQol visual analogue scale, 12-Item Short-Form Health Survey (SF-12), and Forgotten Joint Score. The scores will be calculated preoperatively and then at six weeks, six months, and one year after surgery. The scores will undergo a statistical analysis. Discussion. There is no clear evidence on the best alignment for a knee arthroplasty. This randomized controlled trial will test the null hypothesis that navigated KA TKAs do not perform better than navigated MA TKAs. Cite this article: Bone Jt Open 2021;2(11):945–950

Aims. This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Methods. This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals. Discussion. A multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article: Bone Jt Open 2021;2(11):909–920

Aims. To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture. Methods. This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty). Results. Eight female (29%) and 20 male trainees (71%), mean age 29.4 years, performed 317 DHS operations and 243 hemiarthroplasties during ten months of follow-up. Primary analysis was a random effect model with surgeon-level fixed effects of patient condition, patient age, and surgeon experience, with a random intercept for surgeon. Under the intention-to-treat principle, for hemiarthroplasty there was better implant position in favour of cadaveric training, measured by leg length discrepancy ≤ 10 mm (odds ratio (OR) 4.08 (95% confidence interval (CI) 1.17 to 14.22); p = 0.027). There were significantly fewer postoperative blood transfusions required in patients undergoing hemiarthroplasty by cadaveric-trained compared to standard-trained surgeons (OR 6.00 (95% CI 1.83 to 19.69); p = 0.003). For DHS, there was no significant between-group difference in implant position as measured by tip-apex distance ≤ 25 mm (OR 6.47 (95% CI 0.97 to 43.05); p = 0.053). No between-group differences were observed for any secondary clinical outcomes. Conclusion. Trainees randomized to additional cadaveric training performed hip fracture fixation with better implant positioning and fewer postoperative blood transfusions in hemiarthroplasty. This effect, which was previously unknown, may be a consequence of the intervention. Further study is required. Cite this article: Bone Jt Open 2023;4(8):602–611

Aims. There is no consensus regarding optimum timing and frequency of ultrasound (US) for monitoring response to Pavlik harness (PH) treatment in developmental dysplasia of the hip (DDH). The purpose of our study was to determine if a limited-frequency hip US assessment had an adverse effect on treatment outcomes compared to traditional comprehensive US monitoring. Methods. This study was a single-centre noninferiority randomized controlled trial. Infants aged under six months whose hips were reduced and centred in the harness at initiation of treatment (stable dysplastic or subluxable), or initially decentred (subluxated or dislocated) but reduced and centred within four weeks of PH treatment, were randomized to our current standard US monitoring protocol (every clinic visit) or to a limited-frequency US protocol (US only at end of treatment). Groups were compared based on α angle and femoral head coverage at the end of PH treatment, acetabular indices, and International Hip Dysplasia Institute (IHDI) grade on one-year follow-up radiographs. Results. Overall, 100 patients were included; 42 patients completed the standard protocol (SP) and 40 completed the limited protocol (LP). There was no significant difference in mean right α angle at the end of treatment (SP 70.0° (SD 3.2°) ; LP 68.7° (SD 2.9°); p = 0.033), nor on the left (SP 69.0° (SD 3.5°); LP 68.1° (SD 3.3°); p = 0.128). There was no significant difference in mean right acetabular index at follow-up (SP 23.1° (SD 4.3°); LP 22.0° (SD 4.1°); p = 0.129), nor on the left (SP 23.3° (SD 4.2°); LP 22.8° (SD 3.9°); p = 0.284). All hips had femoral head coverage of > 50% at end of treatment, and all were IHDI grade 1 at follow-up. In addition, the LP group underwent a 60% reduction in US use once stable. Conclusion. Our study supports reducing the frequency of US assessment during PH treatment of DDH once a hip is reduced and centred. Cite this article: Bone Joint J 2022;104-B(9):1081–1088

Aims. This study evaluates the quality of patient-reported outcome measures (PROMs) reported in childhood fracture trials and recommends outcome measures to assess and report physical function, functional capacity, and quality of life using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) standards. Methods. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant systematic review of OVID Medline, Embase, and Cochrane CENTRAL was performed to identify all PROMs reported in trials. A search of OVID Medline, Embase, and PsycINFO was performed to identify all PROMs with validation studies in childhood fractures. Development studies were identified through hand-searching. Data extraction was undertaken by two reviewers. Study quality and risk of bias was evaluated by COSMIN guidelines and recorded on standardized checklists. Results. Searches yielded 13,672 studies, which were screened to identify 124 trials and two validation studies. Review of the 124 trials identified 16 reported PROMs, of which two had validation studies. The development papers were retrieved for all PROMs. The quality of the original development studies was adequate for Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility and Upper Extremity and doubtful for the EuroQol Five Dimension Youth questionnaire (EQ-5D-Y). All other PROMs were found to have inadequate development studies. No content validity studies were identified. Reviewer-rated content validity was acceptable for six PROMs: Activity Scale for Kids (ASK), Childhood Health Assessment Questionnaire, PROMIS Upper Extremity, PROMIS Mobility, EQ-5D-Y, and Pediatric Quality of Life Inventory (PedsQL4.0). The Modified Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire was shown to have indeterminate reliability and convergence validity in one study and PROMIS Upper Extremity had insufficient convergence validity in one study. Conclusion. There is insufficient evidence to recommend strongly the use of any single PROM to assess and report physical function or quality of life following childhood fractures. There is a need to conduct validation studies for PROMs. In the absence of these studies, we cautiously recommend the use of the PROMIS or ASK-P for physical function and the PedsQL4.0 or EQ-5D-Y for quality of life. Cite this article: Bone Joint J 2020;102-B(12):1599–1607

Aims. Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients. Methods. This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively. Results. A total of 60 patients were randomized, 32 to the standard group and 28 to the detailed group. Patients in the detailed group had significantly higher total recall score compared to the standard group (mean difference 1.29 points (95% confidence interval (CI) 0.51 to 2.08); p = 0.002). There were no differences in HADS-A (mean difference 0.39 (95% CI -2.11 to 2.88); p = 0.757), VAS pain (mean difference 5.71 (95% CI -22.25 to 11.11); p = 0.499), or PSQ-18 (mean difference 0.499; 95% CI -1.6 to 3.42; p = 0.392). Conclusion. Detailed written tools are useful in improving postoperative recall in adult orthopaedic trauma patients. Cite this article: Bone Jt Open 2023;4(2):104–109

Aims. The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA). Methods. A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size. Results. A total of 116 patients participated, of whom 77 were male. The median ages of the vE-PE 32 mm and 36 mm groups were 65 (interquartile range (IQR) 57 to 67) and 63 years (IQR 56 to 66), respectively, and of the XLPE 32 mm and 36 mm groups were 64 (IQR 58 to 66) and 61 years (IQR 54 to 66), respectively. Mean total head penetration was significantly lower into vE-PE acetabular liner groups than into XLPE acetabular liner groups (-0.219 mm (95% confidence interval -0.348 to -0.090); p = 0.001). There were no differences in wear according to head size, acetabular component migration, or PROMs, except for UCLA. There were no cases of aseptic loosening or failures requiring revision at long-term follow-up. Conclusion. Significantly lower wear was observed in vE-PE acetabular liners than in XLPE acetabular liners. No difference in wear was observed between different head size or PROMs except for the UCLA at ten years. Cite this article: Bone Joint J 2023;105-B(10):1052–1059

Aims. The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups. Methods. A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178). Discussion. The results of this study will help guide treatment of dorsally displaced distal radial fractures in the elderly and assess whether surgery offers functional benefit to patients. This is an important finding, as the number of elderly distal radial fractures is estimated to increase in the future due to the ageing population. Evidence-based management strategies are therefore required to ensure the best outcome for the patient and to optimize the use of increasingly scarce healthcare resources. Cite this article: Bone Jt Open 2024;5(10):920–928

Aims. It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting. Methods. In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure. Results. The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur. Conclusion. Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups. Cite this article: Bone Joint J 2024;106-B(7):696–704

Aims. The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients. Methods. A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up. Results. There was no clinically relevant difference in terms of migration of the femoral component or PROMs between the HXLPE and PE groups. The mean difference in migration (maximum total point motion), five years postopeatively, was 0.04 mm (95% CI -0.06 to 0.16) in favour of the PE group. Conclusion. There was no clinically relevant difference in migration of the femoral component, for up to five years between the two groups. These findings will help to establish a benchmark for future studies on migration of femoral components in TKA. Cite this article: Bone Joint J 2024;106-B(8):826–833

Aims. The primary aim of this study was to compare the migration of the femoral and tibial components of the cementless rotating platform Attune and Low Contact Stress (LCS) total knee arthroplasty (TKA) designs, two years postoperatively, using radiostereometric analysis (RSA) in order to assess the risk of the development of aseptic loosening. A secondary aim was to compare clinical and patient-reported outcome measures (PROMs) between the designs. Methods. A total of 61 TKAs were analyzed in this randomized clinical RSA trial. RSA examinations were performed one day and three, six, 12, and 24 months postoperatively. The maximal total point motion (MPTM), translations, and rotations of the components were analyzed. PROMs and clinical data were collected preoperatively and at six weeks and three, six, 12, and 24 months postoperatively. Linear mixed effect modelling was used for statistical analyses. Results. The mean MTPM two years postoperatively (95% confidence interval (CI)) of the Attune femoral component (0.92 mm (0.75 to 1.11)) differed significantly from that of the LCS TKA (1.72 mm (1.47 to 2.00), p < 0.001). The Attune femoral component subsided, tilted (anteroposteriorly), and rotated (internal-external) significantly less. The mean tibial MTPM two years postoperatively did not differ significantly, being 1.11 mm (0.94 to 1.30) and 1.17 mm (0.99 to 1.36, p = 0.447) for the Attune and LCS components, respectively. The rate of migration in the second postoperative year was negligible for the femoral and tibial components of both designs. The mean pain-at-rest (numerical rating scale (NRS)-rest) in the Attune group was significantly less compared with that in the LCS group during the entire follow-up period. At three months postoperatively, the Knee injury and Osteoarthritis Outcome Physical Function Shortform score, the Oxford Knee Score, and the NRS-activity scores were significantly better in the Attune group. Conclusion. The mean MTPM of the femoral components of the cementless rotating platform Attune was significantly less compared with that of the LCS design. This was reflected mainly in significantly less subsidence, posterior tilting, and internal rotation. The mean tibial MTPMs were not significantly different. During the second postoperative year, the components of both designs stabilized and low risks for the development of aseptic loosening are expected. Cite this article: Bone Joint J 2023;105-B(2):148–157