Aims. A pragmatic, single-centre, double-blind randomized clinical trial was conducted in a NHS teaching hospital to evaluate whether there is a difference in functional knee scores, quality-of-life outcome assessments, and complications at one-year after intervention between total knee arthroplasty (TKA) and patellofemoral arthroplasty (PFA) in patients with severe isolated patellofemoral arthritis. Methods. This parallel, two-arm, superiority trial was powered at 80%, and involved 64 patients with severe isolated patellofemoral arthritis. The primary outcome measure was the functional section of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months. Secondary outcomes were the full 24-item WOMAC, Oxford Knee Score (OKS), American Knee Society Score (AKSS), EuroQol five dimension (EQ-5D) quality-of-life score, the University of California, Los Angeles (UCLA) Physical Activity Rating Scale, and complication rates collected at three, six, and 12 months. For longer-term follow-up, OKS, EQ-5D, and self-reported satisfaction score were collected at 24 and 60 months. Results. Among 64 patients who were randomized, five patients did not receive the allocated intervention, three withdrew, and one declined the intervention. There were no statistically significant differences in the patients’ WOMAC function score at 12 months (adjusted mean difference, -1.2 (95% confidence interval -9.19 to 6.80); p = 0.765). There were no clinically significant differences in the secondary outcomes. Complication rates were comparable (superficial surgical site infections, four in the PFA group versus five in the TKA group). There were no statistically significant differences in the patients’ OKS score at 24 and 60 months or self-reported satisfaction score or pain-free years. Conclusion. Among patients with severe isolated patellofemoral arthritis, this study found similar functional outcome at 12 months and mid-term in the use of PFA compared with TKA. Cite this article: Bone Joint J 2020;102-B(3):310–318

Aims. Modern total knee arthroplasty (TKA) prostheses are designed to restore near normal kinematics including high flexion. Kneeling is a high flexion, kinematically demanding activity after TKA. The debate about design choice has not yet been informed by six-degrees-of-freedom in vivo kinematics. This prospective randomized clinical trial compared kneeling kinematics in three TKA designs. Methods. In total, 68 patients were randomized to either a posterior stabilized (PS-FB), cruciate-retaining (CR-FB), or rotating platform (CR-RP) design. Of these patients, 64 completed a minimum one year follow-up. Patients completed full-flexion kneeling while being imaged using single-plane fluoroscopy. Kinematics were calculated by registering the 3D implant models onto 2D-dynamic fluoroscopic images and exported for analysis. Results. CR-FB designs had significantly lower maximal flexion (mean 116° (SD 2.1°)) compared to CR-RP (123° (SD 1.6°)) and PS-FB (125° (SD 2.1°)). The PS-FB design displayed a more posteriorly positioned femur throughout flexion. Furthermore, the CR-RP femur was more externally rotated throughout kneeling. Finally, individual patient kinematics showed high degrees of variability within all designs. Conclusion. The increased maximal flexion found in the PS-FB and CR-RP designs were likely achieved in different ways. The PS-FB design uses a cam-post to hold the femur more posteriorly preventing posterior impingement. The external rotation within the CR-RP design was surprising and hasn’t previously been reported. It is likely due to the polyethylene bearing being decoupled from flexion. The findings of this study provide insights into the function of different knee arthroplasty designs in the context during deep kneeling and provide clinicians with a more kinematically informed choice for implant selection and may allow improved management of patients' functional expectations. Cite this article: Bone Joint J 2021;103-B(1):105–112

Aims. Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA. The purpose of this multicentre randomized clinical trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. Patients and Methods. From six-centres, 233 revision TKAs were randomized to one of four regimens: 1 g of intravenous (IV) TXA given prior to the skin incision, a double-dose regimen of 1 g IV TXA given both prior to skin incision and at time of wound closure, a combination of 1 g IV TXA given prior to skin incision and 1 g of intraoperative topical TXA, or three doses of 1950 mg oral TXA given two hours preoperatively, six hours postoperatively, and on the morning of postoperative day one. Randomization was performed based on the type of revision procedure to ensure equivalent distribution among groups. Power analysis determined that 40 patients per group were necessary to identify a 1 g/dl difference in the reduction of haemoglobin postoperatively between groups with an alpha of 0.05 and power of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence. Results. In total, one patient withdrew, five did not undergo surgery, 16 were screening failures, and 25 did not receive the assigned treatment, leaving 186 patients for analysis. There was no significant difference in haemoglobin reduction among treatments (2.8 g/dl for single-dose IV TXA, 2.6 g/dl for double-dose IV TXA, 2.6 g/dl for combined IV/topical TXA, 2.9 g/dl for oral TXA; p = 0.38). Similarly, calculated blood loss (p = 0.65) and transfusion rates (p = 0.95) were not significantly different between groups. Equivalence testing assuming a 1 g/dl difference in haemoglobin change as clinically relevant showed that all possible pairings were statistically equivalent. Conclusion. Despite the higher risk of blood loss in revision TKA, all TXA regimens tested had equivalent blood-sparing properties. Surgeons should consider using the lowest effective dose and least costly TXA regimen in revision TKA. Cite this article: Bone Joint J 2019;101-B(Supple 7):10–16

Aims. The aim of this study was to investigate the difference in functional outcome after repair and non-repair of the pronator quadratus muscle in patients undergoing surgical treatment for a distal radial fracture with volar plating. Patients and Methods. A total of 72 patients with a distal radial fracture were included in this randomized clinical trial. They were allocated to have the pronator quadratus muscle repaired or not, after volar locked plating of a distal radial fracture. The patients, the assessor, the primary investigator, and the statistician were blinded to the allocation. Randomization was irreversibly performed using a web application that guaranteed a secure and tamper-free assignment. The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) after 12 months. Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH) score, pronation strength, grip strength, the range of pronation and supination, complications, and the operating time. Results. Of the 72 patients, 63 (87.5%) completed follow-up for the primary outcome measure: 31 (86.1%) from the non-repair group and 32 (88.9%) from the repair group. At the 12-month follow-up, the mean difference in PRWE of 5.47 (95% confidence interval (CI) -4.02 to 14.96) between the repair (mean 18.38 (95% CI 10.34 to 26.41)) and non-repair group (mean 12.90 (95% CI 7.55 to 18.25)) was not statistically significant (p = 0.253). There was a statistically significant difference between pronation strength, favouring non-repair. We found no difference in the other secondary outcomes. Conclusion. We found that repairing pronator quadratus made no difference to the clinical outcome, 12 months after volar plating of a distal radial fracture. We conclude that there is no functional advantage in repairing this muscle under these circumstances and advise against it. Cite this article: Bone Joint J 2019;101-B:1498–1505

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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.

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The aims of this study were first, to determine if adding fusion to a decompression of the lumbar spine for spinal stenosis decreases the rate of radiological restenosis and/or proximal adjacent level stenosis two years after surgery, and second, to evaluate the change in vertebral slip two years after surgery with and without fusion.

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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.

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Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation.

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The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures

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Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.

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Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures.

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To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups.

Aims. Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty – the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most. Methods. We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure health-related quality of life at one, four, and 12 months postoperatively. Results. Our analysis revealed a complex landscape of responses to the use of a cemented hemiarthroplasty in the 12 months after surgery. There was heterogeneity of effects with regard to baseline characteristics, including age, pre-injury health status, and lifestyle factors such as alcohol consumption. This heterogeneity was greater at the one-month mark than at subsequent follow-up timepoints, with particular regard to subgroups based on age. However, for all subgroups, the effect estimates for quality of life lay within the confidence intervals derived from the analysis of all patients. Conclusion. The use of a cemented hemiarthroplasty is expected to increase health-related quality of life compared with modern uncemented hemiarthroplasty for all subgroups of patients aged > 60 years with a displaced intracapsular fracture of the hip. Cite this article: Bone Joint J 2024;106-B(7):656–661

Aims. Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported. Methods. We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a ‘drain’ or ‘no drain’ group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up. Results. As previously reported, the mean 48-hour opioid consumption was significantly higher in the no drain group (2.0 mg/kg (SD 0.8) vs 1.4 mg/kg (SD 0.7); p = 0.005). There were no delayed deep SSIs. At two years’ follow-up, the mean Scoliosis Research Society 24-item questionnaire (SRS-24) total score did not differ between the groups (4.11 (SD 0.47) vs 4.16 (SD 0.33); p = 0.910). The mean SRS-24 pain score was 4.28 (SD 0.48) in the no drain group compared with 4.33 (SD 0.66) in the drain group (p = 0.245). Seven patients (19%) in the no drain group and six in the drain group (14%) reported moderate to severe pain (numerical rating scale ≥ 4) at two years’ follow-up (p = 0.484). The general self-image domain score was significantly higher in the no drain group compared with the drain group (4.02 (SD 0.74) vs 4.59 (SD 0.54); p < 0.001). Conclusion. The main finding in this study was that more severe pain immediately after surgery did not result in a higher incidence of chronic pain in the no drain group compared with the drain group. Back pain and health-related quality of life at two years’ follow-up did not differ between the groups. The patient-reported self-image domain was significantly better in the no drain group compared with the drain group. Cite this article: Bone Joint J 2024;106-B(10):1176–1181

Aims. The aim of this study was to evaluate the epidemiology and treatment of Perthes’ disease of the hip. Methods. This was an anonymized comprehensive cohort study of Perthes’ disease, with a nested consented cohort. A total of 143 of 144 hospitals treating children’s hip disease in the UK participated over an 18-month period. Cases were cross-checked using a secondary independent reporting network of trainee surgeons to minimize those missing. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. Overall, 371 children (396 hips) were newly affected by Perthes’ disease arising from 63 hospitals, with a median of two patients (interquartile range 1.0 to 5.5) per hospital. The annual incidence was 2.48 patients (95% confidence interval (CI) 2.20 to 2.76) per 100,000 zero- to 14-year-olds. Of these, 117 hips (36.4%) were treated surgically. There was considerable variation in the treatment strategy, and an optimized decision tree identified joint stiffness and age above eight years as the key determinants for containment surgery. A total of 348 hips (88.5%) had outcomes to two years, of which 227 were in the late reossification stage for which a hip shape outcome (Stulberg grade) was assigned. The independent predictors of a poorer radiological outcome were female sex (odds ratio (OR) 2.27 (95% CI 1.19 to 4.35)), age above six years (OR 2.62 (95% CI (1.30 to 5.28)), and over 50% radiological collapse at inclusion (OR 2.19 (95% CI 0.99 to 4.83)). Surgery had no effect on radiological outcomes (OR 1.03 (95% CI 0.55 to 1.96)). PROMs indicated the marked effect of the disease on the child, which persisted at two years. Conclusion. Despite the frequency of containment surgery, we found no evidence of improved outcomes. There appears to be a sufficient case volume and community equipoise among surgeons to embark on a randomized clinical trial to definitively investigate the effectiveness of containment surgery. Cite this article: Bone Joint J 2022;104-B(4):510–518

Aims. To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs. Methods. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. The incremental cost of standard dressing versus iNPWT over six months was £2,037 (95% confidence interval (CI) £349 to £3,724). There was an insignificant increment in QALYs gained in the iNPWT group (0.005, 95% CI -0.018 to 0.028). The probability of iNPWT being cost-effective at £20,000 per QALY was 1.9%. The results remained robust in the sensitivity analysis. Conclusion. The within-trial economic evaluation suggests that iNPWT is unlikely to be a cost-effective alternative to standard dressing in adults with closed surgical wounds to their lower limbs. Cite this article: Bone Joint J 2020;102-B(8):1072–1081

Aims. The aim is to assess the cost-effectiveness of patellofemoral arthroplasty (PFA) in comparison with total knee arthroplasty (TKA) for the treatment of isolated patellofemoral osteoarthritis (OA) based on prospectively collected data on health outcomes and resource use from a blinded, randomized, clinical trial. Methods. A total of 100 patients with isolated patellofemoral osteoarthritis were randomized to receive either PFA or TKA by experienced knee surgeons trained in using both implants. Patients completed patient-reported outcomes including EuroQol five-dimension questionnaire (EQ-5D) and 6-Item Short-Form Health Survey questionnaire (SF-6D) before the procedure. The scores were completed again after six weeks, three, six, and nine months, and again after one- and two-year post-surgery and yearly henceforth. Time-weighted outcome measures were constructed. Cost data were obtained from clinical registrations and patient-reported questionnaires. Incremental gain in health outcomes (quality-adjusted life-years (QALYs)) and incremental costs were compared for the two groups of patients. Net monetary benefit was calculated assuming a threshold value of €10,000, €35,000, and €50,000 per QALY and used to test the statistical uncertainty and central assumptions about outcomes and costs. Results. The PFA group had an incremental 12 month EQ-5D gain of 0.056 (95% confidence interval (CI) 0.01 to 0.10) and an incremental 12 month cost of minus €328 (95% CI 836 to 180). PFA therefore dominates TKA by providing better and cheaper outcomes than TKA. The net monetary benefit of PFA was €887 (95% CI 324 to 1450) with the €10,000 threshold, and it was consistently positive when different measures of outcomes and different cost assumptions were used. Conclusion. This study provides robust evidence that PFA from a one-year hospital management perspective is cheaper and provides better outcomes than TKA when applied to patients with isolated patellofemoral osteoarthritis and performed by experienced knee surgeons. Cite this article: Bone Joint J 2020;102-B(4):449–457

Aims. To establish whether there was a consensus among the members of the Hip Society (HS) on the role of direct anterior approach (DAA) contemporary primary total hip arthroplasty (THA). Methods. An online survey was sent to all 112 active and senior members of the HS, to which 71 members responded. The survey was constructed to determine whether they believed that evidence-based medicine proves, in modern clinical practice, that the DAA has significant benefits compared to risks when contrasted with other approaches. In addition, they were asked if they currently used the DAA. Results. While only 16.9% (12/71) of respondents had been trained in a generic anterior approach during residency, 49.3% (35/71) had used the DAA in their clinical practice in the past or were using it at the present time. Unexpectedly, 42.9% (15/35) of respondents who had used the DAA in the past had abandoned it by the time of this survey. Only 22.5% (16/71) of all respondents believed that evidence-based medicine proves that the DAA has significant benefits compared to risks in contrast to other approaches. Conclusion. A comprehensive literature review found only three prospective randomized clinical trials (RCT) comparing the DAA with another approach with greater than one-year follow-up. Two showed minor benefits within the early postoperative period only, and one of those showed poorer mid-term results. Most of the published comparison studies with short follow-up show longer surgical times and greater blood loss for the DAA, and many three-month comparison studies show higher complication rates for the DAA using a proprietary traction table. The complications included problems with wound healing, lateral femoral cutaneous nerve injury, femoral component loosening, and femoral fractures. Because of the lack of evidence from RCTs showing superiority of the DAA over other approaches and reports of higher complications, the opinion of a large majority (77.5%; 55/71) of HS surgeons was that the DAA lacks sufficient evidence to warrant its use. Cite this article: Bone Joint J 2020;102-B(7 Supple B):57–61

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A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening.