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

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.

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. Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB. Methods. The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after GHJ injection or SSNB in patients with frozen shoulder. This will help provide effective treatment to patients with frozen shoulder. Cite this article: Bone Jt Open 2023;4(3):205–209

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

Aims. Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. Methods. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group. Conclusion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72–78

Aims

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.

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.

Aims

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.

Aims

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

Aims

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.

Aims

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.

Aims

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.

The December 2022 Trauma Roundup. 360. looks at: Anterior approach for acetabular fractures using anatomical plates; Masquelet–Ilizarov for the management of bone loss post debridement of infected tibial nonunion; Total hip arthroplasty – better results after low-energy displaced femoral neck fracture in young patients; Unreamed intramedullary nailing versus external fixation for the treatment of open tibial shaft fractures in Uganda: a randomized clinical trial; The Open-Fracture Patient Evaluation Nationwide (OPEN) study: the management of open fracture care in the UK; Cost-utility analysis of cemented hemiarthroplasty versus hydroxyapatite-coated uncemented hemiarthroplasty; Unstable ankle fractures: fibular nail fixation compared to open reduction and internal fixation; Long-term outcomes of randomized clinical trials: wrist and calcaneus; ‘HeFT’y follow-up of the UK Heel Fracture Trial

The October 2023 Trauma Roundup. 360. looks at: Intramedullary nailing versus sliding hip screw in trochanteric fracture management: the INSITE randomized clinical trial; Five-year outcomes for patients with a displaced fracture of the distal tibia; Direct anterior versus anterolateral approach in hip joint hemiarthroplasty; Proximal humerus fractures: treat them all nonoperatively?; Tranexamic acid administration by prehospital personnel; Locked plating versus nailing for proximal tibia fractures: a multicentre randomized controlled trial; A retrospective review of the rate of septic knee arthritis after retrograde femoral nailing for traumatic femoral fractures at a single academic institution

The June 2024 Trauma Roundup. 360. looks at: Skin antisepsis before surgical fixation of limb fractures; Comparative analysis of intramedullary nail versus plate fixation for fibula fracture in supination external rotation type IV ankle injury; Early weightbearing versus late weightbearing after intramedullary nailing for distal femoral fracture (AO/OTA 33) in elderly patients: a multicentre propensity-matched study; Long-term outcomes with spinal versus general anaesthesia for hip fracture surgery; Operative versus nonoperative management of unstable medial malleolus fractures: a randomized clinical trial; Impact of smoking status on fracture-related infection characteristics and outcomes; Reassessing empirical antimicrobial choices in fracture-related infections; Development and validation of the Nottingham Trauma Frailty Index (NTFI) for older trauma patients

The February 2023 Trauma Roundup. 360. looks at: Masquelet versus bone transport in infected nonunion of tibia; Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multicentre randomized clinical trial; Is the T-shaped acetabular fracture really a “T”?; What causes cut-out of proximal femur nail anti-rotation device in intertrochanteric fractures?; Is the common femoral artery at risk with percutaneous fragility pelvis fixation?; Anterior pelvic ring pattern predicts displacement in lateral compression fractures; Differences in age-related characteristics among elderly patients with hip fractures

The December 2023 Shoulder & Elbow Roundup. 360. looks at: Clavicle fractures: is the evidence changing practice?; Humeral shaft fractures, and another meta-analysis…let’s wait for the trials now!; Hemiarthroplasty or total elbow arthroplasty for distal humeral fractures…what does the registry say?; What to do with a first-time shoulder dislocation?; Deprivation indices and minimal clinically important difference for patient-reported outcomes after arthroscopic rotator cuff repair; Prospective randomized clinical trial of arthroscopic repair versus debridement for partial subscapularis tears; Long-term follow-up following closed reduction and early movement for simple dislocation of the elbow; Sternoclavicular joint reconstruction for traumatic acute and chronic anterior and posterior instability

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Aims. This study sought to estimate the clinical outcomes and describe the nationwide variation in practice, as part of the feasibility workup for a National Institute for Health and Care Excellence (NICE) recommended randomized clinical trial to determine the optimal treatment of torus fractures of the distal radius in children. Methods. Prospective data collection on torus fractures presenting to our emergency department. Patient consent and study information, including a copy of the Wong-Baker Faces pain score, was issued at the first patient contact. An automated text message service recorded pain scores at days 0, 3, 7, 21, and 42 postinjury. A cross-sectional survey of current accident and emergency practice in the UK was also undertaken to gauge current practice following the publication of NICE guidance. Results. In all, 30 patients with a mean age of 8.9 years were enrolled over a six-week period. Of the 150 potential data points, data was captured in 146, making the data 97.3% complete. Pain scores were recorded at day 0 (mean 6.5 (95% confidence interval (CI) 5.7 to 7.3)), day 3 (4.4 (95% CI 3.5 to 5.2)), day 7 (3.0 (95% CI 2.3 to 3.6)), day 21 (1.2 (95% CI 0.7 to 1.7)) and day 42 (0.4 (95% CI 0.1 to 0.7)). Of the 100 units who participated in the nationwide survey, 38% were unaware of any local or national protocols regarding torus fractures, 41% treated torus fractures with cast immobilization, and over 60% of patients had follow-up arranged, both contradictory to national guidelines. Conclusion. We have demonstrated the severity, recovery trajectory, and variation in pain scores among children with torus fractures. We demonstrate excellent follow-up of patient outcomes using text messages. Despite national guidelines, there is significant variation in practice. This data directly informed the development of an ongoing nationwide randomized clinical trial – the FORearm Fracture Recovery in Children Evaluation (FORCE) study

The February 2023 Shoulder & Elbow Roundup. 360. looks at: Arthroscopic capsular release or manipulation under anaesthesia for frozen shoulder?; Distal biceps repair through a single incision?; Distal biceps tendon ruptures: diagnostic strategy through physical examination; Postoperative multimodal opioid-sparing protocol vs standard opioid prescribing after knee or shoulder arthroscopy: a randomized clinical trial; Graft healing is more important than graft technique in massive rotator cuff tear; Subscapularis tenotomy versus peel after anatomic shoulder arthroplasty; Previous rotator cuff repair increases the risk of revision surgery for periprosthetic joint infection after reverse shoulder arthroplasty; Conservative versus operative treatment of acromial and scapular spine fractures following reverse total shoulder arthroplasty

The trapeziometacarpal joint (TMCJ) is the most common hand joint affected by osteoarthritis (OA), and trapezium implant arthroplasty is a potential treatment for recalcitrant OA. This meta-analysis aimed to investigate the efficacy and safety of various trapezium implants as an interventional option for TMCJ OA. Web of Science, PubMed, Scopus, Google Scholar, and Cochrane library databases were searched for relevant studies up to May 2022. Preferred Reported Items for Systematic Review and Meta-Analysis guidelines were adhered to and registered on PROSPERO. The methodological quality was assessed by National Heart, Lung, and Blood Institute tools for observational studies and the Cochrane risk of bias tool. Subgroup analyses were performed on different replacement implants, the analysis was done via Open Meta-Analyst software and P values < 0.05 were considered statistically significant. A total of 123 studies comprising 5752 patients were included. Total joint replacement (TJR) implants demonstrate greater significant improvements in visual analogue scale pain scores postoperatively. Interposition with partial trapezial resection implants was associated with the highest grip strength and highest reduction in the Disabilities of the Arm, Shoulder, and Hand score. Revision rates were highest in TJR (12.3%), and lowest in interposition with partial trapezial resection (6.2%). Total joint replacement and interposition with partial trapezial resection implants improve pain, grip strength, and DASH scores more than other implant options. Future studies should focus on high-quality randomized clinical trials comparing different implants to accumulate higher quality evidence and more reliable conclusions

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. 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

Introduction/Purpose. A randomized clinical trial of first MTP joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years. Methods. One hundred nineteen patients were evaluated at 5+ years; 23 could not be reached for follow-up, but implant status was available for 7 of these subjects. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: ≥30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated. Results. Of 119 patients available at mean 5.8 years follow-up (SD ±0.7; range: 4.4–8.0), 9 underwent implant removal and conversion to fusion in years 2–5, leaving 106 patients. The implant survival rate was 92.4% at 5.8 years. Pain and function outcomes at 5.8 years were similar to those at 2 years. VAS Pain, FAAM Sports, ADL Scores were maintained or improved at 5.8 years. No evidence of avascular necrosis, device migration or fragmentation was observed. There were no unanticipated safety events through 5.8 years. Ninety-three (93%) percent would have the procedure again. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with evidence of therapeutic effect and acceptable safety profile at 5.8 years

Aims. People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). Methods. An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. Results. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion. This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK. Cite this article: Bone Jt Open 2024;5(7):612–620

Aim. In 10% of the presumed aseptic hip or knee revisions, a low-grade infection is unexpectedly diagnosed based on the tissue samples taken during revision. Extended antimicrobial prophylaxis can possibly reduce the failure rate in cases of unexpected PJI, because the prophylaxis can be considered as early empiric treatment. In this randomized controlled study we analysed whether extended antimicrobial prophylaxis compared to a single dose is beneficial to improve the outcome of treatment in unexpected PJI in revision arthroplasty. Method. This study was nested in a randomized clinical trial comparing single-dose cefazolin with prolonged prophylaxis (15 doses of cefazolin over 5 days) for revision arthroplasty of the hip or knee. For this analysis, patients were included if an unsuspected PJI (defined as ≥2 positive intraoperative tissue samples with the same microorganism) was diagnosed. PJI treatment consisted of 12 weeks of a rifampicin-based regimen in Staphylococcal PJI, without removal of the prosthesis. We examined Infection characteristics and success of treatment after one year, defined as the absence of signs or treatment for PJI during follow-up. Results. After randomization of 662 patients, 68 unexpected PJI were diagnosed. In 5 cases no antimicrobial treatment was started. The success rate after one year follow-up for those who received PJI treatment was 96% (28/29) in the single dose group and 91% (31/34) in the extended prophylaxis group (p=1.00). The most frequently identified pathogens in unexpected PJI were Cutibacterium acnes (n=50) and Staphylococcus epidermidis (n=14). The causatives were susceptible for the cefazolin prophylaxis in 61 of the 63 cases. The interval between the stopped prophylaxis and the re-start of antimicrobial treatment was on average 10 days (SD 4) for the single dose and 5 days (SD 4) for the extended group. The mean duration of antimicrobial treatment was 83 days (SD 12) and did not differ between both groups (p=0.16). Conclusions. This is the first randomized controlled trial in which extended prophylaxis showed no benefit on the prosthesis survival for patients with an unexpected PJI after assumed aseptic revision of the hip or knee prosthesis. The results imply that extended prophylaxis should not be given as part of early empiric therapy

Aims. Hand trauma accounts for one in five of emergency department attendances, with a UK incidence of over five million injuries/year and 250,000 operations/year. Surgical site infection (SSI) in hand trauma surgery leads to further interventions, poor outcomes, and prolonged recovery, but has been poorly researched. Antimicrobial sutures have been recognized by both the World Health Organization and the National Institute for Clinical Excellence as potentially effective for reducing SSI. They have never been studied in hand trauma surgery: a completely different patient group and clinical pathway to previous randomized clinical trials (RCTs) of these sutures. Antimicrobial sutures are expensive, and further research in hand trauma is warranted before they become standard of care. The aim of this protocol is to conduct a feasibility study of antimicrobial sutures in patients undergoing hand trauma surgery to establish acceptability, compliance, and retention for a definitive trial. Methods. A two-arm, multicentre feasibility RCT of 116 adult participants with hand and wrist injuries, randomized to either antimicrobial sutures or standard sutures. Study participants and outcome assessors will be blinded to treatment allocation. Outcome measures will be recorded at baseline (preoperatively), 30 days, 90 days, and six months, and will include SSI, patient-reported outcome measures, and return to work. Conclusion. This will inform a definitive trial of antimicrobial sutures in the hand and wrist, and will help to inform future upper limb trauma trials. The results of this research will be shared with the medical community through high impact publication and presentation. Cite this article: Bone Jt Open 2022;3(7):529–535

Previously, we conducted a multi-center, double-blinded randomized controlled trial comparing arthroscopic Bankart repair with and without remplissage. The end point for the randomized controlled trial was two years post-operative, providing support for the benefits of remplissage in the short term in reducing recurrent instability. The aim of this study was to compare the medium term (3 to 9 years) outcomes of patients previously randomized to have undergone isolated Bankart repair (NO REMP) or Bankart repair with remplissage (REMP) for the management of recurrent anterior glenohumeral instability. The rate of recurrent instability and instances of re-operation were examined. The original study was a double-blinded, randomized clinical trial with two 1:1 parallel groups with recruitment undertaken between 2011 and 2017. For this medium-term study, participants were reached for a telephone follow-up in 2020 and asked a series of standardized questions regarding ensuing instances of subluxation, dislocation or reoperation that had occurred on their shoulder for which they were randomized. Descriptive statistics were generated for all variables. “Failure” was defined as occurrence of a dislocation. “Recurrent instability” was defined as the participant reporting a dislocation or two or more occurences of subluxation greater than one year post-operative. All analyses were undertaken based on intention-to-treat whereby their data was analyzed based on the group to which they were originally allocated. One-hundred and eight participants were randomized of which 50 in the NO REMP group and 52 in the REMP group were included in the analyses in the original study. The mean number of months from surgery to final follow-up was 49.3 for the NO REMP group and 53.8 for the REMP group. The rates of re-dislocation or failure were 8% (4/52) in the REMP group at an average of 23.8 months post-operative versus 22% (11/50) in the NO REMP at an average of 16.5 months post-operative. The rates of recurrent instability were 10% (5/52) in the REMP group at an average of 24 months post-operative versus 30% (15/50) in the NO REMP group at an average of 19.5 months post-operative. Survival curves were significantly different favouring REMP in both scenarios. Arthroscopic Bankart repair combined with remplissage is an effective procedure in the treatment of patients with an engaging Hill-Sachs lesion and minimal glenoid bone loss (<15%). Patients can expect favourable rates of recurrent instability when compared with isolated Bankart repair at medium term follw-up

Fracture nonunion is a severe clinical problem for the patient, as well as for the clinician. About 5-20% of fractures does not heal properly after more than six months, with a 19% nonunion rate for tibia, 12% for femur and 13% for humerus, leading to patient morbidity, prolonged hospitalization, and high costs. The standard treatment with iliac crest-derived autologous bone filling the nonunion site may cause pain or hematoma to the patient, as well as major complications such as infection. The application of mesenchymal autologous cells (MSC) to improve bone formation calls for randomized, open, two-arm clinical studies to verify safety and efficacy. The ORTHOUNION * project (ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs) is a multicentric, open, randomized, comparative phase II clinical trial, approved in the framework of the H2020 funding programme, under the coordination of Enrique Gòmez Barrena of the Hospital La Paz (Madrid, Spain). Starting from January 2017, patients with nonunion of femur, tibia or humerus have been actively enrolled in Spain, France, Germany, and Italy. The study protocol encompasses two experimental arms, i.e., autologous bone marrow-derived mesenchymal cells after expansion (‘high dose’ or ‘low dose’ MSC) combined to ceramic granules (MBCP™, Biomatlante), and iliac crest-derived autologous trabecular bone (ICAG) as active comparator arm, with a 2-year follow-up after surgery. Despite the COVID 19 pandemic with several lockdown periods in the four countries, the trial was continued, leading to 42 patients treated out of 51 included, with 11 receiving the bone graft (G1 arm), 15 the ‘high dose’ MSC (200x10. 6. , G2a arm) and 16 the ‘low dose’ MSC (100x10. 6. , G2b arm). The Rizzoli Orthopaedic Institute has functioned as coordinator of the Italian clinical centres (Bologna, Milano, Brescia) and the Biomedical Science and Technologies and Nanobiotechnology Lab of the RIT Dept. has enrolled six patients with the collaboration of the Rizzoli’ 3rd Orthopaedic and Traumatological Clinic prevalently Oncologic. Moreover, the IOR Lab has collected and analysed the blood samples from all the patients treated to monitor the changes of the bone turnover markers following the surgical treatment with G1, G2a or G2b protocols. The clinical and biochemical results of the study, still under evaluation, are presented. * ORTHOUNION Horizon 2020 GA 733288

Aim. There are no studies in literature that analyze the effectiveness of closed-incisional negative pressure wound therapy (ciNPWT) in the treatment of bone and joint infections (BJI). The aim of the study was to evaluate the efficacy and the safety of the application of ciNPWT in the postsurgical wound management of patients with osteoarticular infections. Method. We conducted a perspective single-center study on patients with BJI treated between 01/2022 and 10/2022 with ciNPWT dressing application at the end of the surgical procedure. All patients were treated by a multidisciplinary team (MDT) approach and operated by the same surgical equipe. Inclusion criteria were: presence of periprosthetic joint infection (PJI), fracture-related infection (FRI), osteomyelitis (OM), septic arthritis (SA) surgically treated, after which ciNPTW was applied over the closed surgical wound. 30 patients (19M, 11F) have been analyzed with mean age of 56,10±17,11 years old; BJIs were all localized in the lower limb (16 PJI, 12 FRI, 1 SA, 1 OM). Results. We considered the following clinical local pre-operative parameters: presence of fistula (10 patients, 33,33%), presence of erythema (18 patients, 60%), presence of previous flap in the incisional site (7 patients, 23,33%). In 11 cases (36,67%) more than 3 previous surgical procedures were performed in the surgical site. The following surgical procedures were performed: 8 debridement and implants removal, 7 DAIR, 3 one-stage exchange, 6 two-stage exchange, 3 spacer exchange, 3 resection arthroplasty. Nineteen patients (63,34%) showed no occurrence of any local post-operative complication (erythema, hematoma, wound breakdown, wound blister, necrosis). Seven (23,33%) patients showed the presence of one or more postoperative complications that didn't require additional surgery. We observed four (13,33%) failures, defined as the need for further surgical procedures following the onset of a local complication: two patients had a wound breakdown before wound closure and two had a recurrence of infection after an uneventfully wound closure. All failures were within the group of joint infection (PJI+SA) and were affected by a multi drug resistant pathogen. Conclusions. In our series four patients required further surgery, but only two cases were related to incisional wound problems, that is consistent with aseptic joint revision surgeries data that are available in literature (3.4%-6.9%)[1-2]. Patients affected by BJI are a group with significant high risk of failure and therefore the use of ciNPWT should be considered. However, randomized clinical trials are needed to establish the superiority of the ciNPWT dressing over the standard one

Aims. Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. Methods. We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results. A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible ‘ladder’ approach starting with conservative treatment first; 2) The malleable role of steroid injection; 3) Surgery as an invasive and risky last resort; 4) A shared and collaborative approach; 5) Treating the whole person; and 6) Severity of life impact influences treatment. The remaining eight themes were developed relating to clinical trial barriers and facilitators: 1) We need to embrace uncertainty; 2) You are not losing out by taking part; 3) It is difficult to be neutral about certain treatments; 4) Difficult to recruit to ‘no treatment’ ; 5) Difficult to recruit to a trial comparing no surgery to surgery; 6) Patients are keen to participate in research; 7) Burden on staff and participants; and 8) A enthusiasm for a variety of potential trial arms. Conclusion. Our findings contribute to a better understanding of how clinicians manage thumb CMCJ OA in their practice settings. Our study also provides useful insights informing the design of randomized clinical trials involving steroid injections and surgery in people with thumb CMCJ OA. Cite this article: Bone Jt Open 2022;3(4):321–331

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

The human amniotic membrane (hAM), derived from the placenta, possesses a low (nay inexistant) immunogenicity and exerts an anti-inflammatory, anti-fibrotic, antimicrobial, antiviral and analgesic effect. It is a source of stem cells and growth factors promoting tissue regeneration. hAM acts as an anatomical barrier with adequate mechanical properties (permeability, stability, elasticity, flexibility, resorbability) preventing the proliferation of fibrous tissue and promoting early neovascularization of the surgical site. Cryopreservation and lyophilization, with sometimes additional decellularization process, are the main preservation methods for hAM storage. We examined the use of hAM in orthopaedic and maxillofacial bone surgery, specially to shorten the induced membrane technique (Gindraux, 2017). We investigated the cell survival in cryopreserved hAM (Laurent, 2014) and the capacity of intact hAM of in vitro osteodifferentiation (Gualdi, 2019). We explored its in vivo osteogenic potential in an ectopic model (Laurent, 2017) and, with Inserm U1026 BioTis, in a calvarial defect (Fenelon, 2018). Still piloted by U1026, decellularization and/or lyophilization process were developed (Fenelon, 2019) and, processed hAM capacities was assessed for guided bone regeneration (Fenelon 2020) and induced membrane technique (Fenelon, 2021) in mice. We reported a limited function of hAM for bone defect management. In this light, we recognized medication-related osteonecrosis of the jaw (MRONJ) as appropriate model of disease to evaluate hAM impact on both oral mucosa and bone healing. We treated height compassionate patients (stage II, III) with cryopreserved hAM. A multicentric randomized clinical study (PHRC-I 2020 funding) will be soon conducted in France (regulatory and ethical authorization in progress)

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

Aim. This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing. Method. A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained. Results. A total of 242 patients completed the required follow-up (ciNPT: n = 124 (84.4%); SOC: n = 118 (80.3%)). Demographics, baseline comorbidities, causes of revision (prosthetic joint infection, aseptic loosening, implant-related, and periprosthetic fractures), and duration of treatment were similar in both cohorts (p > 0.05). Intention to treat analysis demonstrated lower rates of SSC with ciNPT (3.4%) compared to SOC (14.3%) (p = 0.0013) (Table 1 – not included in the proceeding). Similar outcomes were obtained with the modified intention to treat analysis (p = 0.0013). The ciNPT cohort exhibited lower readmission rates (p = 0.0208), and number of dressing changes (p = 0.0003). Conversely, differences in the 90-day incidence of SSI and measured patient-reported outcomes did not reach statistical significance (p > 0.05). Conclusions. ciNPT mitigates the risk of SSC and readmission among high-risk rTKA patients. The lower frequency of dressing changes within the ciNPT cohort may provide added value for healthcare utilization without compromising pain and function. For the table, please contact authors directly

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

It is unusual, if not unique, for three major research papers concerned with the management of the fractured neck of femur (FNOF) to be published in a short period of time, each describing large prospective randomized clinical trials. These studies were conducted in up to 17 countries worldwide, involving up to 80 surgical centers and include large numbers of patients (up to 2,900) with FNOF. Each article investigated common clinical dilemmas; the first paper comparing total hip arthroplasty versus hemiarthroplasty for FNOF, the second as to whether ‘fast track’ care offers improved clinical outcomes and the third, compares sliding hip with multiple cancellous hip screws. Each paper has been deemed of sufficient quality and importance to warrant publication in The Lancet or the New England Journal of Medicine. Although ‘premier’ journals, they only occationally contain orthopaedic studies and thus may not be routinely read by the busy orthopaedic/surgical clinician of any grade. It is therefore our intention with this present article to accurately summarize and combine the results of all three papers, presenting, in our opinion, the most important clinically relevant facts. Cite this article: Bone Joint Open 2020;1-6:198–202

Purpose: The purpose of this study was to compare the outcomes of cruciate retaining (CR) and cruciate sacrificing (CS) total knee arthroplasty (TKA) in a multi-center randomized clinical trial with greater than 5 year follow-up. Methods: One hundred and eighty five patients (189 knees) participated in a double-blinded randomized clinical trial. 96 cruciate retaining and 93 cruciate sacrificing total knee arthroplasties (Genesis II, Smith & Nephew, Memphis, TN) were performed between 1997 and 2000. All surgical procedures were performed by twelve surgeons at twelve medical centers. The average follow-up was 5.8 (5.0–7.3) years. Clinical outcomes (Knee Society Clinical Rating, WOMAC, SF-12, Radiographic Findings) were evaluated preoperatively and at the latest follow-up. Postoperative complications were also examined. Results: There were no significant differences when comparing cruciate retaining knees to cruciate sacrificing knees in patient demographics and preoperative clinical evaluation. At the latest follow-up, clinical outcomes (CR versus CS) were as follows: Knee Society Clinical Rating (163±26 versus 165±29), knee flexion (114±11& #12539;versus 118±10& #12539; p< 0.05), WOMAC (12±7 versus 8±6, p< 0.05), and SF-12 (mental: 52±9 versus 58±4, physical: 41±11 versus 42±10). Radiographic outcomes showed there were no differences in radiolucent lines or loosening, and postoperative complication rate was also not significantly different. Conclusions: In this randomized clinical trial, both posterior cruciate preserving (CR) and sacrificing (CS) total knee replacements offer excellent clinical outcomes at five or more years follow-up, with the cruciate sacrificing implant studied demonstrating small, but significant improvements in both range of motion, WOMAC, and disease specific outcomes

Flexible fixation techniques combined with anatomic (open) syndesmosis reduction have demonstrated improved functional outcomes and rates of malreduction. Suture-button devices allow physiologic motion of the syndesmosis without need for implant removal, which may lower the risk of recurrent syndesmotic diastasis. There is limited longer-term assessment of the maintenance of reduction between static and flexible syndesmotic fixation using bilateral ankle CT evaluation. This is an a priori planned subgroup analysis of a multi-centre, randomized clinical trial comparing static syndesmosis fixation (two 3.5 mm screws) with flexible fixation (single knotless Tightrope) for patients with AO- OTA 44-C injuries. Patients who completed bilateral ankle CT scans at 3- and 12-month follow-up were included. The primary outcome measure was syndesmotic malreduction based on bilateral ankle CT scans, using the uninjured, contralateral ankle as a control. Anterior (ASD), middle (MSD), and posterior (PSD) syndesmosis distance were calculated to measure syndesmosis reduction. Secondary outcomes included re-operation, adverse events and functional outcomes including the EQ5D, Olerud-Molander Ankle Score (OM), Foot and Ankle Disability Index (FADI), and Work Productivity Activity Impairment Questionnaire (WPAI). Paired samples t-tests were used to compare injured to control ankles (R, v 3.5.1). 42 patients (24 Group S, 18 Group T) were included. ASD for Group T was 5.22mm (95%CI 4.69–5.77) at 3 months compared to 4.26mm (95%CI 3.82–4.71; p=0.007) in controls and 5.38mm (95%CI 4.72–6.04) at 12 months compared to 4.44mm (95%CI 3.73–5.16; p=0.048) in controls. ASD for Group S was 4.63mm (95%CI 4.17– 5.10) at 3 months compared to 4.67mm (95%CI 4.24–5.10; p=0.61) in controls, but significantly increased to 5.73mm (95%CI 4.81–6.66) at 12 months compared to 4.65mm (95%CI 4.15–5.15; p=0.04) in controls. MSD results were similar; Group T had a larger MSD than control ankles at 3 months (p=0.03) and 12 months (p=0.01), while the MSD in Group S was not different at 3 months (p=0.80) but increased at 12 months (p=<0.01). 88% (21/24) of Group S had broken or removed screws by 12 months. Unplanned re-operation was 15% in Group S and 4% in Group T (p=0.02), with an overall re-operation rate of 30% in Group S. There was no significant difference between treatment groups for EQ-5D, OM, FADI or WPAI at 3- or 12-month follow-up. Tightrope fixation resulted in greater diastasis of the ASD and MSD compared to contralateral, uninjured ankles at 3- and 12-months post-fixation. Group S initially had syndesmotic reduction similar to control ankles, but between 3- and 12-months post-fixation, there was significantly increased syndesmosis diastasis compared to controls. The majority of Group S (88%) had either broken screws or scheduled screw removal, which may explain the increased tibio-fibular diastasis seen at 12-months

Management of the pathologic long-head biceps tendon remains controversial. Biceps tenotomy is a simple intervention but may result in visible deformity and subjective cramping. Comparatively, biceps tenodesis is technically challenging, and has increased operative times, and a more prolonged recovery. The purpose of this study was to determine the incidence of popeye deformity following biceps tenotomy versus tenodesis, identify predictors for developing a deformity, and compare subjective and objective outcomes between those that have one and those that do not. Data for this study were collected as part of a randomized clinical trial comparing tenodesis versus tenotomy in the treatment of lesions of the long head of biceps tendon. Patients 18 years of age or older with an arthroscopy confirmed biceps lesion were randomized to one of these two techniques. The primary outcome measure for this sub-study was the rate of a popeye deformity at 24-months post-operative as determined by an evaluator blinded to group allocation. Secondary outcomes were patient reported presence/absence of a popeye deformity, satisfaction with the appearance of their arm, as well as pain and cramping on a VAS. Isometric elbow flexion and supination strength were also measured. Interrater reliability (Cohen's kappa) was calculated between patient and evaluator on the presence of a deformity, and logistic regression was used to identify predictors of its occurrence. Linear regression was performed to identify if age, gender, or BMI were predictive of satisfaction in appearance if a deformity was present. Fifty-six participants were randomly assigned to each group of which 42 in the tenodesis group and 45 in the tenotomy group completed a 24-month follow-up. The incidence of popeye deformity was 9.5% (4/42) in the tenodesis group and 33% (15/45) in the tenotomy group (18 male, 1 female) with a relative risk of 3.5 (p=0.016). There was strong interrater agreement between evaluator and patient perceived deformity (kappa=0.636; p<0.001). Gender tended towards being a significant predictor of having a popeye with males having 6.6 greater odds (p=0.090). BMI also tended towards significance with lower BMI predictive of popeye deformity (OR 1.21; p=0.051). Age was not predictive (p=0.191). Mean (SD) satisfaction score regarding the appearance of their popeye deformity was 7.3 (2.6). Age was a significant predictor, with lower age associated with decreased satisfaction (F=14.951, adjusted r2=0.582, p=0.004), but there was no association with gender (p=0.083) or BMI (p=0.949). There were no differences in pain, cramping, or strength between those who had a popeye deformity and those who did not. The risk of developing a popeye deformity was 3.5 times higher after tenotomy compared to tenodesis. Male gender and lower BMI tended towards being predictive of having a deformity; however, those with a high BMI may have had popeye deformities that were not as visually apparent to an examiner as those with a lower BMI. Younger patients were significantly less satisfied with a deformity despite no difference in functional outcomes at 24 months. Thus, biceps tenodesis may be favored in younger patients with low BMI to mitigate the risk of an unsatisfactory popeye deformity

Nearly one quarter of ankle fractures have a recognized syndesmosis injury. An intact syndesmosis ligament complex stabilizes the distal tibio-fibular joint while allowing small, physiologic amounts of relative motion. When injured, malreduction of the syndesmosis has been found to be the most important independent factor that contributes to inferior functional outcomes. Despite this, significant variability in surgical treatment remains. This may be due to a poor understanding of normal dynamic syndesmosis motion and the resultant impact of static and dynamic fixation on post-injury syndesmosis kinematics. As the syndesmosis is a dynamic structure, conventional CT static images do not provide a complete picture of syndesmosis position, giving potentially misleading results. Dynamic CT technology has the ability to image joints in real time, as they are moved through a range-of-motion (ROM). The aim of this study was to determine if syndesmosis position changes significantly throughout ankle range of motion, thus warranting further investigation with dynamic CT. This is an a priori planned subgroup analysis of a larger multicentre randomized clinical trial, in which patients with AO-OTA 44-C injuries were randomized to either Tightrope or screw fixation. Bilateral ankle CT scans were performed at 1 year post-injury, while patients moved from maximal dorsiflexion (DF) to maximal plantar flexion (PF). In the uninjured ankles, three measurements were taken at one cm proximal to the ankle joint line in maximal DF and maximal PF: Anterior (ASD), middle (MSD), and posterior (PSD) syndesmosis distance, in order to determine normal syndesmosis position. Paired samples t-tests compared measurements taken at maximal DF and maximal PF. Twelve patients (eight male, six female) were included, with a mean age of 44 years (±13years). The mean maximal DF achieved was 1-degree (± 7-degrees), whereas the mean maximal PF was 47-degrees (± 8-degrees). The ASD in DF was 3.0mm (± 1.1mm) versus 1.9mm (± 0.8mm) in PF (p<0.01). The MSD in DF was 3.3mm (±1.1mm) versus 2.3mm (±0.9mm) in PF (p<0.01). The PSD in DF was 5.3mm (±1.5mm) versus 4.6mm (±1.9mm) in PF (p<0.01). These values are consistent with the range of normal parameters previously reported in the literature, however this is the first study to report the ankle position at which these measurements are acquired and that there is a significant change in syndesmosis measurements based on ankle position. Normal syndesmosis position changes in uninjured ankles significantly throughout range of motion. This motion may contribute to the variation in normal anatomy previously reported and controversies surrounding quantifying anatomic reduction after injury, as the ankle position is not routinely standardized, but rather static measurements are taken at patient-selected ankle positions. Dynamic CT is a promising modality to quantify normal ankle kinematics, in order to better understand normal syndesmosis motion. This information will help optimize assessment of reduction methods and potentially improve patient outcomes. Future directions include side-to-side comparison using dynamic CT analysis in healthy volunteers

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

The optimal management of rotationally-unstable ankle fractures involving the posterior malleolus remains controversial. Standard practice involves trans-syndesmotic fixation (TSF), however, recent attention has been paid to the indirect reduction of the syndesmosis by repairing small posterior malleolar fracture avulsion fragments, if present, using open reduction internal fixation. Posterior malleolus fixation (PMF) may obviate the need for TSF. Given the limited evidence and diversity in surgical treatment options for rotationally-unstable ankle fractures with ankle syndesmosis and posterior malleolar involvement, we sought to assess the research landscape and identify knowledge gaps to address with future clinical trials. We performed a scoping review to investigate rotational ankle fractures with posterior malleolar involvement, utilizing the framework originally described by Arksey and O'Malley. We searched the English language literature using the Ovid Medline and Embase databases. All study types investigating rotationally-unstable ankle fractures with posterior malleolus involvement were categorized into defined themes and descriptive statistics were used to summarize methods and results of each study. A total of 279 articles published from 1988 to 2018 were reviewed, and 70 articles were included in the final analysis. The literature consists of studies examining the surgical treatment strategies for PMF (n=21 studies, 30%), prognosis of rotational ankle fractures with posterior malleolar involvement (n=16 studies, 23%), biomechanics and fracture pattern of these injuries (n=13 studies, 19%), surgical approach and pertinent anatomy for fixation of posterior malleolus fractures (n=12 studies, 17%), and lastly surgical treatment of syndesmotic injuries with PMF compared to TSF (n=4 studies, 6%). Uncontrolled case series of single treatment made up the majority of all clinical studies (n=44 studies, 63%), whereas controlled study designs were the next most common (n=16 studies, 23%). Majority of research in this field has been conducted in the past eight years (n=52 studies, 74%). Despite increasing concern and debate among the global orthopaedic community regarding rotationally-unstable ankle fractures with syndesmosis and posterior malleolar involvement, and an increasing trend towards PMF, optimal treatment remains unclear when comparing TSF to PMF. Current research priorities are to (1) define the specific injury pattern for which PMF adequately stabilizes the syndesmosis, and (2) conduct a randomized clinical trial comparing PMF to TSF with the assistance of the orthopaedic community at large with well-defined clinical outcomes

Aims. The aim of this study was to examine whether tourniquet use can improve perioperative blood loss, early function recovery, and pain after primary total knee arthroplasty (TKA) in the setting of multiple-dose intravenous tranexamic acid. Methods. This was a prospective, randomized clinical trial including 180 patients undergoing TKA with multiple doses of intravenous tranexamic acid. One group was treated with a tourniquet during the entire procedure, the second group received a tourniquet during cementing, and the third group did not receive a tourniquet. All patients received the same protocol of intravenous tranexamic acid (20 mg/kg) before skin incision, and three and six hours later (10 mg/kg). The primary outcome measure was perioperative blood loss. Secondary outcome measures were creatine kinase (CK), CRP, interleukin-6 (IL-6), visual analogue scale (VAS) pain score, limb swelling ratio, quadriceps strength, straight leg raising, range of motion (ROM), American Knee Society Score (KSS), and adverse events. Results. The mean total blood loss was lowest in the no-tourniquet group at 867.32 ml (SD 201.11), increased in the limited-tourniquet group at 1024.35 ml (SD 176.35), and was highest in the tourniquet group at 1,213.00 ml (SD 211.48). The hidden blood loss was lowest in the no-tourniquet group (both p < 0.001). There was less mean intraoperative blood loss in the tourniquet group (77.48 ml (SD 24.82)) than in the limited-tourniquet group (137.04 ml (SD 26.96)) and the no-tourniquet group (212.99 ml (SD 56.35); both p < 0.001). Patients in the tourniquet group showed significantly higher levels of muscle damage and inflammation biomarkers such as CK, CRP, and IL-6 than the other two groups (p < 0.05). Outcomes for VAS pain scores, limb swelling ratio, quadriceps strength, straight leg raising, ROM, and KSS were significantly better in the no-tourniquet group at three weeks postoperatively (p < 0.05), but there were no significant differences at three months. No significant differences were observed among the three groups with respect to transfusion rate, thrombotic events, or the length of hospital stay. Conclusion. Patients who underwent TKA with multiple doses of intravenous tranexamic acid but without a tourniquet presented lower total blood loss and hidden blood loss, and they showed less postoperative inflammation reaction, less muscle damage, lower VAS pain score, and better early knee function. Our results argue for not using a tourniquet during TKA. Cite this article: Bone Joint Res 2020;9(6):322–332

The syndesmosis ligament complex stabilizes the distal tibiofibular joint, while allowing for the subtle fibular motion that is essential for ankle congruity. Flexible fixation with anatomic syndesmosis reduction results in substantial improvements in functional outcomes. New dynamic CT technology allows real-time imaging, as the ankle moves through a range of motion. The aim of this study was to determine if dynamic CT analysis is a feasible method for evaluating syndesmosis reduction and motion following static and flexible syndesmosis fixation. This is a subgroup analysis of a larger multicenter randomized clinical trial, in which patients with AO 44-C injuries were randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5-mm cortical screws, Group S). Surgical techniques and rehabilitation were standardized. Bilateral ankle CT scans were performed at one year post-injury, while patients moved from maximal dorsiflexion (DF) to maximal plantar flexion (PF). Three measurements were taken at one cm proximal to the ankle joint line in maximal DF and maximal PF: anterior, midpoint, and posterior tibiofibular distances. T-tests compared Group T and Group S, and injured and uninjured ankles in each group. Fifteen patients (six Group T [three male], nine Group S [eight male]) were included. There was no difference for mean age (T = 42.8 ± 14.1 years, S = 37 ± 12.6, P = 0.4) or time between injury and CT scan (T = 13 ± 1.8 months, S = 13.2 ± 1.8, P = 0.8). Of note in Group S, seven of nine patients had at least one broken screw and one additional patient had screws removed by the time of their dynamic CT. There was no significant difference between treatment groups for tibiofibular distance measurements in maximal PF or DF. Group T showed no significant difference between the injured and uninjured side for tibiofibular measurements in maximal PF and DF, suggesting anatomic reduction. For Group S, however, there was a significantly larger distance for all three measurements at maximal PF compared to the uninjured ankle (all P < 0 .05). In all but one Group S patient, screws were broken or removed prior to their dynamic CT, allowing possible increased syndesmotic motion, similar to Group T. Despite this, dynamic CT analysis detected increased tibiofibular distance in Group S as ankles moved into maximal PF when compared with the uninjured ankle. Given the importance of anatomic syndesmosis reduction, dynamic ankle CT technology may provide valuable physiologic information warranting further investigation

Summary. A meta-analysis was performed to compare rate of SSI after application of chlorhexidine vs. iodine in total joint arthroplasty. Chlorhexidine had significantly lower odds of SSI. Introduction. Surgical site infections (SSI) are a significant source of morbidity and mortality. The optimal preoperative skin preparation in lower extremity total joint arthroplasty (TJA) remains debatable between chlorhexidine and iodine-containing solutions. This meta-analysis sought compare SSI rates between chlorhexidine cloth application the night before surgery plus povidone-iodine-alcohol (povidone-iodine) solution at surgery or only povidone-iodine at surgery. Methods. A structured literature search was performed using Web of Science, PubMed, and EMBASE databases for randomized clinical trials (RCTs) and comparative studies that evaluated preoperative chlorhexidine-gluconate versus iodine-alcohol exclusively in TJA patients. Databases were searched from database inception to January 2, 2018, and studies were included if they had specific aims and 1) compared preoperative chlorhexidine-gluconate cloths to povidone-iodine at surgery, or 2) if they compared preoperative chlorhexidine-gluconate cloths and povidone-iodine at surgery, to solely povidone-iodine at surgery. The main outcome was deep or superficial SSI at or before 1 year postoperatively. If multiple studies reported the same patient cohort, the more recent study was used. To compare the chlorhexidine versus povidone-iodine groups, pooled odds ratios (OR) and 95% confidence intervals (95% CI) were used to calculate odds of SSI. Results. Four studies involving 2,997 TJA patients were included in this meta-analysis. Three were retrospective cohort studies, and one was a RCT. One retrospective cohort study assessed chlorhexidine to povidone-iodine using a historical control. One RCT compared chlorhexidine to povidone-iodine. The remaining two studies compared chlorhexidine in addition to povidone-iodine, to only povidone-iodine. Bias analysis showed low-to-moderate quality cohort studies and one moderate-quality RCT. Chlorhexidine had significantly lower odds of SSI compared to povidone iodine (OR=0.28; 95%CI: 0.15–0.51; p<0.0001). Conclusion. Preoperative chlorhexidine-gluconate was superior at reducing SSI risk in patients who underwent lower extremity TJA, compared to povidone-iodine. This can potentially lead to decreased morbidity and lower surgical revision rates for infections. For any figures or tables, please contact authors directly

Purpose. Dislocation after revision total hip is a common complication. The purpose of this study was to assess whether a large femoral head (36/40mm) would result in a decreased dislocation rate compared to a standard head (32mm). Method. A randomized clinical trial was undertaken to assess the effect of large femoral heads on dislocation after revision total hip. Patients undergoing revision hip arthroplasty at seven centers were randomized to 32mm head or 36/40mm head. Patients were stratified according to surgeon. Primary endpoint was dislocation. Rates were compared with Fishers exact test. Secondary outcome measures were quality of life: WOMAC, SF-36 and satisfaction. One hundred eighty four patients were randomized: 92 in the 32mm head group and 92 in the large head group. Baseline demographics were similar in the two groups. Patients were followed from two to five years postoperatively. Results. In the large head group dislocation rate was 1.1% (1/92) versus 8.7% (8/92) for the 32mm head (p=0.035). In this study there was no difference in quality of life between the two groups. Conclusion. This randomized clinical trial demonstrates that a large femoral head (36/40mm) can significantly reduce dislocation rate in patients undergoing revision total hip. As a result of this study the authors now routinely use large heads in all revision hip arthroplasty