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. 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. Unicompartmental knee arthroplasty (UKA) is associated with an accelerated recovery, improved functional outcomes, and retention of anatomical knee kinematics when compared to manual total knee arthroplasty (mTKA). UKA is not universally employed by all surgeons as there is a higher revision risk when compared to mTKA. Robotic arm-assisted (ra) UKA enables the surgeon to position the prosthesis more accurately when compared to manual UKA, and is associated with improved functional outcomes and a lower early revision risk. Non-randomized data suggests that, when compared to mTKA, raUKA has a clinically meaningful greater functional benefit. This protocol describes a randomized controlled trial that aims to evaluate the clinical and cost-effectiveness of raUKA compared to mTKA for individuals with isolated medial compartment osteoarthritis (OA). Methods. The total versus robotic-assisted unicompartmental knee arthroplasty (TRAKER) trial is a patient- and assessor-blinded, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary knee arthroplasty for primary medial compartment OA at a single NHS hospital (ClinicalTrials.gov NCT05290818). Participants will be randomly allocated on a 1:2 basis to either raUKA or mTKA, respectively. The primary analysis will compare the Oxford Knee Score (OKS) six months after surgery. Secondary outcomes measured at three, six, and 12 months include the OKS, Forgotten Joint Score, patient expectations, EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (EQ-VAS), patient satisfaction, range of motion, postoperative complications, need for further surgery, resource use, and financial costs. Cost-effectiveness will be measured over a ten-year time span. A total of 159 patients will be randomized (n = 53 raUKA vs n = 106 mTKA) to obtain 80% power to detect a five-point difference in OKS between the groups six months after surgery. Conclusion. The trial findings will provide evidence about the clinical and cost-effectiveness of raUKA compared to mTKA in patients with isolated medial compartment OA. This will inform future National Institute for Health and Care Excellence guidelines on primary knee arthroplasty in the UK. Cite this article: Bone Jt Open 2025;6(2):164–177

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. 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 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. 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. It is unclear if a supportive bandage, removable splint, or walking cast offers the best outcome following low-risk ankle fractures in children. The aim of this study was to evaluate the feasibility of a randomized controlled trial to compare these treatments. Methods. Children aged five to 15 years with low-risk ankle fractures were recruited to this feasibility trial from 1 February 2020 to 30 March 2023. Children were randomized to supportive bandage, removable splint, or walking cast for two weeks. Follow-up at two, six, and 12 weeks was undertaken to determine feasibility for a definitive trial. Outcomes collected included complications, the Patient-Reported Outcomes Measurement Information System (PROMIS) mobility score, Paediatric Quality of Life Inventory, youth version of the EuroQol five-dimension health questionnaire, and Activities Scale for Kids - Performance. Results. A total of 87 children from six hospitals were randomized at a rate of 0.9 participants per site per month. Two children in the supportive bandage group crossed over to an alternative device. Complications were reported in six children. One child in the cast group developed skin blisters. One child in cast and one in bandage sustained a reinjury during the 12-week follow-up, and two children (one splint and one cast) required additional immobilization after the two-week treatment for persistent pain. Of the 84 participants who remained in the study at six weeks, 43 (51.2%) returned follow-up questionnaires at six weeks. Of the patient-reported outcome measures (PROMs), proxy-reported PROMIS mobility showed good responsiveness, low ceiling effects, and low missing item rates. In an exploratory analysis, small differences were observed between groups, with no evidence that any of the treatments were superior. Conclusion. This feasibility study showed acceptable recruitment and retention rates. There remains equipoise regarding the best treatment of these injuries. All three treatments appear well tolerated with similar complication rates. A primary outcome of complications or treatment failure would provide the highest study retention with secondary PROMs and economic analysis. Cite this article: Bone Joint J 2025;107-B(1):108–117

Aims. We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences. Methods. The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded. Results. Five-year follow-up was completed by 213 (95%) of the eligible patients (mean age 67 years; 155 female (67%)). After five years, ODI was similar irrespective of treatment, with a mean of 25 (SD 18) for decompression alone and 28 (SD 22) for decompression with fusion (p = 0.226). Mean EQ-5D was higher for decompression alone than for fusion (0.69 (SD 0.28) vs 0.59 (SD 0.34); p = 0.027). In the no-DS subset, fewer patients reported decreased leg pain after fusion (58%) than with decompression alone (80%) (relative risk (RR) 0.71 (95% confidence interval (CI) 0.53 to 0.97). The frequency of subsequent spinal surgery was 24% for decompression with fusion and 22% for decompression alone (RR 1.1 (95% CI 0.69 to 1.8)). Conclusion. Adding fusion to decompression in spinal stenosis surgery, with or without spondylolisthesis, does not improve the five-year ODI, which is consistent with our two-year report. Three secondary outcomes that did not differ at two years favoured decompression alone at five years. Our results support decompression alone as the preferred method for operating on spinal stenosis. Cite this article: Bone Joint J 2024;106-B(7):705–712

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. Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm. 2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus. Methods. Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans. Results. A total of 40 patients were enrolled and randomly divided into the two groups, with 20 in each. There was no statistically significant difference in the baseline characteristics of the groups. No complications, such as wound infection or neurovascular injury, were found during follow-up of 12 months. The mean AOFAS scores in the rESWT group were significantly higher than those in the control group at three, six, and 12 months postoperatively (p < 0.05). The mean VAS pain scores in the rESWT group were also significantly lower than those in the control group at these times (p < 0.05). The mean area of bone marrow oedema in the rESWT group was significantly smaller at six and 12 months than in the control group at these times (p < 0.05). Conclusion. Local shockwave therapy was safe and effective in patients with osteochondiritis of the talus who were treated with a combination of arthroscopic surgery and rESWT. Preliminary results showed that, compared with arthroscopic microfracture alone, those treated with arthroscopic microfracture combined with rESWT had better relief of pain at three months postoperatively and improved weightbearing and motor function of the ankle. Cite this article: Bone Joint J 2023;105-B(10):1108–1114

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. 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. 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. 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. 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

Aim. One of the most common patient-reported complaints following intramedullary nailing (IMN) of tibial shaft fractures is anterior knee pain reported by 10% to 80% of patients. The present study aimed to compare the 12-month Knee injury and Osteoarthritis Outcome Score (KOOS) sport and recreation activities subscale (sport/rec) scores after IMN with external ring fixation (RF) to adult patients with tibial shaft fractures. Methods. This study was a pragmatic multicentre randomized, non-blinded trial, with two-group parallel design. Included were adult patients (aged ≥ 18 years) presenting with an acute tibial shaft fracture deemed operable with an intramedullary nail. The primary outcome was the KOOS sport/rec, ranging from 0 (worst score) to 100 (best score) at 12-month follow-up. Secondary outcomes included the Foot and Ankle Outcome Score (FAOS), health-related quality of life assessed by EuroQol five-dimension five-level health questionnaire, and pain scores. Results. A total of 67 patients were included in the study. In all, 33 patients were randomized to standard IMN and 34 patients to RF. The mean age of the patients was 47.7 years (SD 19.2; 18 to 84) and 34% were female (n = 23). The primary analysis revealed no statistically significant difference in KOOS sport/rec between the IMN and RF groups at the 12-month follow-up (adjusted mean difference -18.1 (95 % CI -43.4 to 7.2); favouring RF). Conclusion. No statistically significant differences in the KOOS sport/rec were observed between RF and IMN at 12-month follow-up. However, these results should be interpreted with caution, due to high risk of a type II error. Cite this article: Bone Joint J 2025;107-B(3):353–361

Aims. Refobacin Bone Cement R and Palacos R + G bone cement were introduced to replace the original cement Refobacin Palacos R in 2005. Both cements were assumed to behave in a biomechanically similar fashion to the original cement. The primary aim of this study was to compare the migration of a polished triple-tapered femoral stem fixed with either Refobacin Bone Cement R or Palacos R + G bone cement. Repeated radiostereometric analysis was used to measure migration of the femoral head centre. The secondary aims were evaluation of cement mantle, stem positioning, and patient-reported outcome measures. Methods. Overall, 75 patients were included in the study and 71 were available at two years postoperatively. Prior to surgery, they were randomized to one of the three combinations studied: Palacos cement with use of the Optivac mixing system, Refobacin with use of the Optivac system, and Refobacin with use of the Optipac system. Cemented MS30 stems and cemented Exceed acetabular components were used in all hips. Postoperative radiographs were used to assess the quality of the cement mantle according to Barrack et al, and the position and migration of the femoral stem. Harris Hip Score, Oxford Hip Score, Forgotten Joint Score, and University of California, Los Angeles Activity Scale were collected. Results. Median distal migration (y-axis) at two years for the Refobacin-Optivac system was -0.79 mm (-2.01 to -0.09), for the Refobacin-Optipac system was -0.75 mm (-2.16 to 0.20), and for the Palacos-Optivac system was -1.01 mm (-4.31 to -0.29). No statistically significant differences were found between the groups. Secondary outcomes did not differ statistically between the groups at the two-year follow-up. Conclusion. At two years, we found no significant differences in distal migration or clinical outcomes between the three groups. Our data indicate that Refobacin Bone Cement R and Palacos R + G are comparable in terms of stable fixation and early clinical outcomes. Cite this article: Bone Joint J 2024;106-B(5):435–441

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. The primary aim of this trial was to compare the subsidence of two similar hydroxyapatite-coated titanium femoral components from different manufacturers. Secondary aims were to compare rotational migration (anteversion/retroversion and varus/valgus tilt) and patient-reported outcome measures between both femoral components. Methods. Patients were randomized to receive one of the two femoral components (Avenir or Corail) during their primary total hip arthroplasty between August 2018 and September 2020. Radiostereometric analysis examinations at six, 12, and 24 months were used to assess the migration of each implanted femoral component compared to a baseline assessment. Patient-reported outcome measures were also recorded for these same timepoints. Overall, 50 patients were enrolled (62% male (n = 31), with a mean age of 65.7 years (SD 7.3), and mean BMI of 30.2 kg/m. 2. (SD 5.2)). Results. The two-year subsidence was similar for Avenir (-0.018 mm (95% confidence interval (CI) -0.053 to 0.018) and Corail (0.000 mm (95% CI -0.027 to 0.026; p = 0.428). Both anteversion/retroversion (Avenir 0.139° (95% CI -0.204 to 0.481°); Corail -0.196° (95% CI -0.445 to 0.053°; p = 0.110) and varus/valgus tilt (Avenir -0.024° (95% CI -0.077 to 0.028); Corail -0.049° (95% CI -0.098 to 0.000°; p = 0.473) were not statistically significantly different. After two years, patients reported similar improvements in EuroQol five-dimension five-level health questionnaire (Avenir 0.22 (SD 0.2); Corail 0.22 (SD 0.18); p = 0.965) and other outcomes scores. Patient satisfaction on a five-point Likert scale was also similar between both groups after two years (Avenir 1.38 (SD 0.88); Corail 1.33 (SD 0.57); p = 0.846). Conclusion. The performance of both femoral components was similar in terms of stability and patient outcomes. Cite this article: Bone Joint J 2023;105-B(10):1045–1051