Background. The controversy concerning the benefits of unisegmental cervical disc arthroplasty (CDA) over anterior cervical discectomy and fusion (ACDF) is still open because some randomised clinical trial (RTC) comparing ACDF with CDA have been highly inconclusive. Most of these studies mixed disc prosthesis with dissimilar kinematic characteristics. To date, a compilation of the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) compared with a single cervical disc arthroplasty (CDA) design, the Bryan disc has partially accomplished. Methods. This is a systematic review of RCTs with level I-II evidence. Only RCTs reporting clinical outcomes were included in this review. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of total 51 studies were entered in the study. RTC's were searched from the earliest available records in 2005 to December 2014. Results. Five studies were Level I, and five were Level II. Out of a total of 1101 patients, 562 patients were randomly assigned into the Bryan arthroplasty group and the remaining 539 patients into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing CDA had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with Bryan CDA had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level were slightly higher in patients with ACDF, showing no statistically significant difference. Conclusions. This review of evidence level I-II RCTs comparing clinical and radiological outcomes of patient undergoing Bryan arthroplasty or ACDF indicated a global superiority of the Bryan disc. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and Bryan arthroplasty. These data suggest that even though the loss of motion has a determinant influence in the development of degenerative changes in ACDF cases, these kinematic factors do not imply a higher rate of symptomatic adjacent segment degeneration requiring surgery. Level of Evidence. Level I

The orthopaedic unit at the Golden Jubilee National Hospital consists of eight consultant orthopaedic surgeons who have a varied practice with regard to navigated TKA with some surgeons using navigation for all cases, some for what are deemed difficult cases and others using it rarely or not at all. One mechanical jig-based system and two different navigation systems are in routine use. The results from the two navigated (nav 1 and nav 2) and non-navigated (non-nav) systems were audited and compared with published studies to determine whether the reported results from randomised controlled trials were reproduced in our routine practice. The primary outcome measure was the mechanical femorotibial (MFT) angle as measured by Hip-Knee-Ankle (HKA) radiographs. This is a standard outcome measure that allowed ready comparison with other studies. Demographic data and post-operative MFT angles were collected retrospectively for each patient. The HKA digital radiographs (stored on a Picture Archive and Communication system) were taken six to twelve weeks post-operatively. The MFT angle was measured using a standardised protocol, which used the method of Mose to find the centre of the femoral head, the highest point in the femoral notch as the centre of the knee and the middle of the talus for the centre of the ankle. Repeated measurements were taken to identify intra- and inter-observer error. There were 86 patients in the nav 1 series, 95 in nav 2 and 95 in non-nav. Mean age was nav 1 = 70, nav 2 = 69 and non-nav = 71. Mean BMI was nav 1 = 34, nav 2 = 31.5 and non-nav = 30. Male to female ratio was nav 1 = 51:35, nav 2 = 44:51 and non-nav = 30:65. Intra- and inter- observer comparison showed a maximum difference of 1° for the measurement of MFT angle. For series nav 1 74% of TKAs had a MFT angle in the range ±3°, for series nav 2 this was 85% and for the non-nav series it was 68%. Much of the literature on RCTs for navigation vs. non navigation outcomes in TKA indicates that over 93 % of patients undergoing navigated TKA have a mechanical axis alignment within the ±3° range, with non-navigated techniques having 73–87% within this range [. 1. ,. 2. ]. Our audit shows lower percentages for both navigated and non-navigated techniques. Our results are however similar to those obtained by Chauhan et al. [. 3. ] with 85% and 66% respectively. The lower numbers of patients falling into the ±3° range may be due to our audit covering a number of surgeons and trainees. The nav 1 series had five consultants and six trainees, nav 2 had two consultants and the non-nav series had four consultant and six trainees. It may also relate to the extent of pre-operative deformities, which were not quantified. In conclusion the high levels of TKA coronal alignment within ±3° seen in many RCTs may not be readily reproducible in a general setting

Aims. Rotator cuff tear (RCT) is the leading cause of shoulder pain, primarily associated with age-related tendon degeneration. This study aimed to elucidate the potential differential gene expressions in tendons across different age groups, and to investigate their roles in tendon degeneration. Methods. Linear regression and differential expression (DE) analyses were performed on two transcriptome profiling datasets of torn supraspinatus tendons to identify age-related genes. Subsequent functional analyses were conducted on these candidate genes to explore their potential roles in tendon ageing. Additionally, a secondary DE analysis was performed on candidate genes by comparing their expressions between lesioned and normal tendons to explore their correlations with RCTs. Results. We identified 49 genes in torn supraspinatus tendons associated with advancing age. Among them, five age-related genes showed DE in lesioned tendons compared to normal tendons. Functional analyses and previous studies have highlighted their specific enrichments in biological functions, such as muscle development (e.g. myosin heavy chain 3 (MYH3)), transcription regulation (e.g. CCAAT enhancer binding brotein delta (CEBPD)), and metal ion homeostasis (e.g. metallothionein 1X (MT1X)). Conclusion. This study uncovered molecular aspects of tendon ageing and their potential links to RCT development, offering insights for targeted interventions. These findings enhance our understanding of the mechanisms of tendon degeneration, allowing potential strategies to be made for reducing the incidence of RCT. Cite this article: Bone Joint Res 2024;13(9):474–484

Aims. This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. Methods. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. Results. Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. Conclusion. The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773–784

Aims. There has been an increasing use of early operative fixation for scaphoid fractures, despite uncertain evidence. We conducted a meta-analysis to evaluate up-to-date evidence from randomized controlled trials (RCTs), comparing the effectiveness of the operative and nonoperative treatment of undisplaced and minimally displaced (≤ 2 mm displacement) scaphoid fractures. Methods. A systematic review of seven databases was performed from the dates of their inception until the end of March 2021 to identify eligible RCTs. Reference lists of the included studies were screened. No language restrictions were applied. The primary outcome was the patient-reported outcome measure of wrist function at 12 months after injury. A meta-analysis was performed for function, pain, range of motion, grip strength, and union. Complications were reported narratively. Results. Seven RCTs were included. There was no significant difference in function between the groups at 12 months (Hedges’ g 0.15 (95% confidence interval -0.02 to 0.32); p = 0.082). The complication rate was higher in the operative group and involved more serious complications. Conclusion. We found no difference in functional outcome at 12 months for fractures of the waist of the scaphoid with ≤ 2 mm displacement treated operatively or nonoperatively. The complication rate was higher with operative treatment. Cite this article: Bone Joint J 2022;104-B(8):953–962

Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103

The principal of “function priority, early rehabilitation, and return to sports” is now the goal for sports injury rehabilitation. Neuromuscular electrical stimulation for anterior cruciate ligament (ACL) reconstruction is a rising procedure for early rehabilitation. This paper systematically assessed the effects of neuromuscular electrical stimulation on postoperative ACL reconstruction to provide guidance for physiotherapist and patient when designing a suitable rehabilitation protocol. To evaluate the interventional outcomes of neuromuscular electrical stimulation following ACL reconstruction, we searched PubMed, EMbase, the Cochrane Library, Web of Science and CNKI to collect all randomized controlled trials (RCTs) comparing the effects with neuromuscular electrical stimulation and without intervention on rehabilitation after ACL reconstruction up to January 30, 2022. Two investigators independently performed literature screening, data extraction, bias assessment of risk, and used RevMan 5.3 software to conduct a meta-analysis. A total of six RCTs were included, and the results showed that the use of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction significantly improved the International Knee Documentation Committee (IKDC) scores (MD 6.33, 95% CI [-0.43, 12.22]; I2 = 66%; p = 0.040), the Lysholm score (MD 7.94, 95% CI [6.49, 9.39]; I2 = 89%; p < 0.001), and the range of motion (ROM) (MD 9.99, 95% CI [7.97, 12.02]; I2 = 81%; p < 0.001) in the knees when compared to the control group without using neuromuscular electrical stimulation. Existing evidence show that neuromuscular electrical stimulation is beneficial for early rehabilitation after ACL reconstruction. The use of neuromuscular electrical stimulation is encouraged in the design of rehabilitation protocol. However, due to the limited number of RCT studies and the small sample size, further multi-center RCTs with more participants are needed for a higher-level evidence

There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included pain (visual analogue scale VAS), rate of Popeye deformity, and operative time. 860 patients from 11 RCTs (426 tenotomy vs 434 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.14, 95% CI −0.04 to 0.32; p=0.13). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. There was no significant difference for pain (VAS). Tenodesis resulted in a lower rate of Popeye deformity (OR 0.29, 95% CI 0.19 to 0.45, p < 0.00001). Tenotomy demonstrated a shorter operative time (MD 15.21, 95% CI 1.06 to 29.36, p < 0.00001). Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. A large multi-centre clinical effectiveness randomised controlled trial is needed to provide clarity in this area

Abstract. Objectives. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Results. Nine randomised controlled trials (RCTs) and 19 observational studies fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. This study reports a significantly decreased relative risk of complications when femoral diaphyseal fractures in children aged 4 to 12 are managed with plates. The overall quality of evidence is low, highlighting the need for a prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior

Abstract. Introduction. This study aimed to assess the effect of PRP on knee articular cartilage content (thickness and/or volume) and establish if there is a correlation between changes in cartilage and clinical outcomes in patients with knee osteoarthritis. Methodology. A systematic review was performed following the Cochrane methodology. Studies were included if they reported on cartilage content with MRI or Ultrasound before and after the injection. A random-effects model meta-analysis was performed. Results. 11 studies (n=786) from 1,453 records met the inclusion criteria, with five (n=444) being RCTs. The PRP treatment protocol varied widely. Follow-up ranged from 6–12 months. Eight studies reported increase in cartilage content in the PRP group as compared to control (four showing significant difference). In meta-analysis: PRP treatment was not associated with a significant increase in cartilage thickness in medial and lateral femoral condyle, or in the overall cartilage content (4 studies, n=187, Hedges’ g: 0.079; 95%CI: 0.358-0.516; p=0.723). Meta-analysis of 3 RCTs (n=112) showed no significant difference in increasing cartilage content overall with PRP injections compared with no PRP (Hedges’ g: 0.217; 95%CI: -0.177 – 0.611; P=0.281). There was no correlation between changes in cartilage and clinical outcomes following PRP treatment. Conclusion. Treatment of knee osteoarthritis with PRP is not associated with a significant increase in articular cartilage content and any effect on cartilage is not associated with better clinical outcomes. A multi-centre, adequately powered RCT, with a standardized preparation / administration protocol assessing long-term effect of PRP in knee osteoarthritis is needed to guide clinical care

In recent literature, the fragility index (FI) has been used to evaluate the robustness of statistically significant findings of dichotomous outcomes. This metric is defined as the minimum number of outcome events to flip study conclusions from significant to nonsignificant. Orthopaedics literature is frequently found to be fragile with a median FI of 2 in 150 RCTs across spine, hand, sports medicine, trauma and orthopaedic oncology studies. While many papers discuss limitations of FI, we aimed to further characterize it by introducing the Fragility Likelihood (FL), a new metric that allows us to consider the probability of the event to occur and to calculate the likelihood of this fragility to be reached. We systematically reviewed all randomized controlled trials in the Journal of Bone and Joint Surgery (Am) over 10 years. The FL was calculated with the following formula: A x B x C x 100% (A= FI; B = probability of the event in the group with the smallest number of events; C= probability of the non-event in the group with the highest number of events). A smaller FL demonstrates more robust results and conversely, a larger FL illustrates a higher likelihood of fragility being reached and more fragile the findings. The median FI for the statistically significant outcomes was 2 (Mean: 3.8; Range 0-23). The median FL for the statistically significant outcomes was 11% (Mean: 22%, Range: 2%-73%). This means that the probability of reaching non-significance is only 11% when considering the probability of the event to occur. When comparing studies with the same FI we found the FL to range from 3% to 43%. This illustrates the large differences in robustness between trials with equal FI when the likelihood of the event was taken into consideration. As orthopaedic studies are frequently reported as fragile, we found that by calculating the FL, studies may be more robust than previously assumed based off FI alone. By using the FL in conjunction with FI and p-values will provide additional insight into the robustness of the reported outcomes. Our results indicate that by calculating the FL, study conclusions are stronger than what the FI alone predicts. Although conducting RCTs in surgery can be challenging, we must endeavor to critically evaluate our results so we can answer important orthopaedic questions with certainty

Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common injections include steroids, hyaluronic acid (HA), local anaesthetic, and platelet-rich plasma (PRP). Network meta-analysis allows for comparisons between two or more treatment groups and uses direct and indirect comparisons between interventions. This network meta-analysis aims to compare the efficacy of various IA injections used in the management of hip OA with a follow-up of up to six months. Methods. This systematic review and network meta-analysis used a Bayesian random-effects model to evaluate the direct and indirect comparisons among all treatment options. PubMed, Web of Science, Clinicaltrial.gov, EMBASE, MEDLINE, and the Cochrane Library were searched from inception to February 2023. Randomized controlled trials (RCTs) which evaluate the efficacy of HA, PRP, local anaesthetic, steroid, steroid+anaesthetic, HA+PRP, and physiological saline injection as a placebo, for patients with hip OA were included. Results. In this meta-analysis of 16 RCTs with a total of 1,735 participants, steroid injection was found to be significantly more effective than placebo injection on reported pain at three months, but no significant difference was observed at six months. Furthermore, steroid injection was considerably more effective than placebo injection for functional outcomes at three months, while the combination of HA+PRP injection was substantially more effective at six months. Conclusion. Evidence suggests that steroid injection is more effective than saline injection for the treatment of hip joint pain, and restoration of functional outcomes. Cite this article: Bone Joint J 2024;106-B(6):532–539

Introduction and Objective. The most common paediatric orthopaedic injury requiring hospital admission is a femoral fracture. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The National Institute for Health and Care Excellence (NICE) and the American Academy of Orthopaedic Surgeons (AAOS) have issued relevant guidelines, however, there is limited evidence to support these. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Materials and Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Secondary outcomes assessed the risk of pre-specified individual complications. Results. Nine randomised controlled trials (RCTs) and 19 observational studies (six prospective and 13 retrospective) fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN fixation (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN fixation in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. Although NICE and the AAOS recommend FIN for femoral diaphyseal fractures in children aged 4 to 12, this study reports a significantly decreased relative risk of complications when these injuries are managed with plates. Our findings provide valuable information to healthcare professionals who are involved in discussing the risk and benefits of different management options with patients and their families. The overall quality of evidence is low, highlighting the need for a rigorous prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior

Considerable debate exists regarding which agent(s) should be preferred for venous thromboembolism (VTE) chemical prophylaxis following joint replacement. We assessed the practice of surgeons regarding VTE chemical prophylaxis for primary THR and TKR, pre and post issuing of updated NICE guidance in 2018. A survey, circulated through the British Hip Society and regional trainee networks/collaboratives, was completed by 306 UK surgeons at 187 units. VTE chemical prophylaxis prescribing patterns for surgeons carrying out primary THR (n=258) and TKR (n=253) in low-risk patients were assessed post publication of 2018 NICE recommendations. Prescribing patterns before and after the NICE publication were subsequently explored. Questions were also asked about surgeon equipoise for participation in future RCTs. Following the new guidance, 34% (n=87) used low-molecular weight heparin (LMWH) alone, 33% (n=85) aspirin (commonly preceded by LMWH), and 31% (n=81) direct oral anticoagulants (DOACs: with/without preceding LMWH) for THR. For TKR, 42% (n=105) used aspirin (usually monotherapy), 31% (n=78) LMWH alone, and 27% (n=68) DOAC (with/without preceding LMWH). NICE guidance changed the practice of 34% of hip and 41% of knee surgeons, with significantly increased use of aspirin preceded by LMWH for THR (before=25% vs. after=73%;p<0.001), and aspirin for TKR (before=18% vs. after=84%;p<0.001). Significantly more regimens were NICE guidance compliant after the 2018 update for THR (before=85.7% vs. after=92.6%;p=0.011) and TKR (before=87.0% vs. after=98.8%;p<0.001). Support from surgeons for future RCTs was dependent on the clinical question, ranging from 48% participation in trials (effectiveness of aspirin vs. a DOAC) to 79% (effectiveness of 14 days LMWH vs. 28 days LMWH). Over one-third of surveyed surgeons changed their VTE chemical prophylaxis in response to 2018 NICE recommendations, with more THR and TKR surgeons now compliant with latest NICE guidance. The major change in practice was an increased use of aspirin for VTE chemical prophylaxis. Furthermore, there is an appetite amongst UK surgeons for participating in future RCTs, with a trial comparing standard versus extended duration LMWH likely feasible in current practice

Aims. The aim of this study was to determine the effectiveness of home-based prehabilitation on pre- and postoperative outcomes in participants awaiting total knee (TKA) and hip arthroplasty (THA). Methods. A systematic review with meta-analysis of randomized controlled trials (RCTs) of prehabilitation interventions for TKA and THA. MEDLINE, CINAHL, ProQuest, PubMed, Cochrane Library, and Google Scholar databases were searched from inception to October 2022. Evidence was assessed by the PEDro scale and the Cochrane risk-of-bias (ROB2) tool. Results. A total of 22 RCTs (1,601 patients) were identified with good overall quality and low risk of bias. Prehabilitation significantly improved pain prior to TKA (mean difference (MD) -1.02: p = 0.001), with non-significant improvements for function before (MD -0.48; p = 0.06) and after TKA (MD -0.69; p = 0.25). Small preoperative improvements were observed for pain (MD -0.02; p = 0.87) and function (MD -0.18; p = 0.16) prior to THA, but no post THA effect was found for pain (MD 0.19; p = 0.44) and function (MD 0.14; p = 0.68). A trend favouring usual care for improving quality of life (QoL) prior to TKA (MD 0.61; p = 0.34), but no effect on QoL prior (MD 0.03; p = 0.87) or post THA (MD -0.05; p = 0.83) was found. Prehabilitation significantly reduced hospital length of stay (LOS) for TKA (MD -0.43 days; p < 0.001) but not for THA (MD, -0.24; p = 0.12). Compliance was only reported in 11 studies and was excellent with a mean value of 90.5% (SD 6.82). Conclusion. Prehabilitation interventions improve pain and function prior to TKA and THA and reduce hospital LOS, though it is unclear if these effects enhance outcomes postoperatively. Cite this article: Bone Jt Open 2023;4(5):315–328

Aims. This systematic review and meta-analysis aimed to compare the influence of patellar resurfacing following cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty (TKA) on the incidence of anterior knee pain, knee-specific patient-reported outcome measures, complication rates, and reoperation rates. Methods. A systematic review of MEDLINE, PubMed, and Google Scholar was performed to identify randomized controlled trials (RCTs) according to search criteria. Search terms used included: arthroplasty, replacement, knee (Mesh), TKA, prosthesis, patella, patellar resurfacing, and patellar retaining. RCTs that compared patellar resurfacing versus unresurfaced in primary TKA were included for further analysis. Studies were evaluated using the Scottish Intercollegiate Guidelines Network assessment tool for quality and minimization of bias. Data were synthesized and meta-analysis performed. Results. There were 4,135 TKAs (2,068 resurfaced and 2,027 unresurfaced) identified in 35 separate cohorts from 33 peer-reviewed studies. Anterior knee pain rates were significantly higher in unresurfaced knees overall (odds ratio (OR) 1.84; 95% confidence interval (CI) 1.20 to 2.83; p = 0.006) but more specifically associated with CR implants (OR 1.95; 95% CI 1.0 to 3.52; p = 0.030). There was a significantly better Knee Society function score (mean difference (MD) -1.98; 95% CI -1.1 to -2.84; p < 0.001) and Oxford Knee Score (MD -2.24; 95% CI -0.07 to -4.41; p = 0.040) for PS implants when patellar resurfacing was performed, but these differences did not exceed the minimal clinically important difference for these scores. There were no significant differences in complication rates or infection rates according to implant design. There was an overall significantly higher reoperation rate for unresurfaced TKA (OR 1.46 (95% CI 1.04 to 2.06); p = 0.030) but there was no difference between PS or CR TKA. Conclusion. Patellar resurfacing, when performed with CR implants, resulted in lower rates of anterior knee pain and, when used with a PS implant, yielded better knee-specific functional outcomes. Patellar resurfacing was associated with a lower risk of reoperation overall, but implant type did not influence this. Cite this article: Bone Joint J 2023;105-B(6):622–634

Abstract. Objectives. To determine the effects of self-management interventions (SMIs) including an exercise component (EC) on low back pain (LBP) and disability and to determine whether SMIs with tailored exercises (TEs) have superior outcomes compared to SMIs with general exercises (GEs). Methods. An electronic systematic search of randomized controlled trials (RCTs) was performed in 5 electronic databases. RCTs compared SMIs with an EC to control interventions. Data were extracted at 3 follow-up points (short-term, intermediate and long-term) and meta-analyses were performed. Reviewed RCTs were divided into subgroups based on whether the EC was tailored or generic. A subgroup meta-analysis was performed at the short-term follow-up to assess whether the SMIs with TEs have superior outcomes compared to SMIs with GEs. Results. 12 original RCTs were included in the review (six including SMIs with TEs) and were of moderate quality. The pooled results revealed the effect sizes (ESs) of −0.26,-0.32 and −0.21 for short, intermediate and long-term pain intensity, respectively and −0.26,-0.22 and −0.21 for short, intermediate, and long-term disability, respectively (negative value indicates a mean difference in favour of SMIs) indicating a moderate but significant reduction in pain and disability compared to controls. Subgroup meta-analysis at the short-term follow-up revealed that SMIs with TEs had ES of –0.19(p=0.004) for pain and –0.20(p=0.002) for disability compared to SMIs with GEs demonstrating positive but not significant improvement in pain (ES −0.48, p=0.09) and disability (ES −0.45, p=0.10). Conclusions. There is moderate quality evidence for SMIs with an EC to have moderate but significant positive effect on pain and disability in people with LBP. The subgroup analysis revealed that SMIs with exercises tailored to person's needs are superior in reducing pain and disability. These results indicate the importance of developing TE solutions supporting self-management to improve its effect on pain and disability in LBP patients. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Background and Aim of Study. Despite several hundred RCTs of exercise for persistent non-specific low back pain (NSLBP), the treatment targets of exercise are unclear. In a systematic review we observed 30 direct and indirect treatment targets of exercise described across 23 RCTs for persistent NSLBP. Since not all treatment targets and outcomes can be assessed in all RCTs, it is therefore important to prioritise these treatment targets through consensus from key stakeholders. These consensus workshops aimed to agree treatment targets for the use of exercise interventions in randomised controlled trials (RCTs) in persistent NSLBP using nominal group workshop (NGW) methodology. Methods and Results. The first UK workshop included people who had experience of exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design exercise interventions tested in RCTs. The second workshop included participants attending an international back and neck pain research workshop. Twelve participants took part in the UK NGW and fifteen took part in the final ranking of the exercise treatment targets. In addition to the original list of 30 treatment targets, a further 26 ideas were generated. After grouping and voting, 18 treatment targets were prioritised. The top five ranked targets of exercise interventions for persistent NSLBP were: pain reduction, improvement in function, reduction of fear of movement, encouragement of normal movement and improvement of mobility. The results of the international NGW will also be presented. Conclusion. Future RCTs of exercise should consider more consistent assessment of these treatment targets. Sources of Funding: This PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Conflicts of Interest: No conflicts of interest

Introduction and Objective. There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. Materials and Methods. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included visual analogue scale (VAS), rate of cosmetic deformity (Popeye sign), range of motion, operative time, and elbow flexion strength. Results. 751 patients from 10 RCTs demonstrated (369 tenotomy vs 382 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.17 95% CI −0.02 to 0.36, p=0.09). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. Secondary outcomes including VAS, shoulder external rotation, and elbow flexion strength did not reveal any significant difference. Tenodesis resulted in a lower rate of Popeye deformity (OR 0.27 95% CI 0.16 to 0.45, p<0.00001). Conclusions. Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. This finding was irrespective of the whether the rotator cuff was intact

Abstract. Objectives. Intra-articular corticosteroid injections (IACIs) are a well-established non-surgical treatment for the symptoms of osteoarthritis (OA), which can provide short-term improvements in pain, disability and quality of life (QoL). Many patients receive recurrent IACIs as temporary relief of their symptoms. Longer-term outcomes for recurrent IACIs remain less well-researched. This meta-analysis aimed to investigate the longer-term risks and benefits of IACIs beyond 3 months. Methods. We searched MEDLINE, EMBASE, and CENTRAL from inception to January 07, 2021, for randomised controlled trials (RCTs) where patients with OA had received recurrent IACIs. Our primary outcomes were pain and function. Secondary outcomes included QoL, disease progression, radiological changes, and adverse events. Mean differences with 95% confidence intervals were reported. Results. Ten RCTs met eligibility criteria (eight for knee OA [n=378], two for trapeziometacarpal OA [n=57]). Patients received 2–5 injections. Follow-up ranged from 6–24 months. Patients with knee OA showed mild improvement in pain at 3, 6, and 9 months but not at 12 months post-injection compared to baseline. Improvements in function were seen from 3–24 months post-injection, decreasing over time. Improvements in QoL continued at 24 months. For patients with trapeziometacarpal OA, mild improvements in pain, function, and QoL were demonstrated at 3–6 months (and 12 months for pain) compared to baseline. No serious adverse events were recorded. No studies reported on time-to-future interventions, or risk of future periprosthetic joint infection. Conclusions. Only mild improvements in pain, function, and QoL were noted after recurrent IACIs up to 6–24 months post-injection. Existing RCTs on recurrent IACI lacks sufficient follow-up data to assess disease progression and time-to-future interventions. These results will inform the RecUrrent Intra-articular Corticosteroid injections in Osteoarthritis (RUbICOn) study which aims to establish the long-term safety outcomes of IACI through data linkage of clinical practice data, hospital episode statistics, and national PROMs

Introduction and Objective. Tranexamic acid (TXA) is used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in trauma, spinal surgery, and lower limb arthroplasty. The aim of this study is to investigate the clinical effectiveness of TXA in all types of shoulder surgery on bleeding and non-bleeding related outcomes. Materials and Methods. This study was registered prospectively on the PROSPERO database (ref: CRD42020185482). A systematic review and meta-analysis of randomised controlled trials (RCTs) investigating intra-operative use of TXA versus placebo in any type of surgery to the shoulder girdle. Electronic databases searched included MEDLINE, EMBASE, PsychINFO, and the Cochrane Library. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and Jadad score. Certainty of findings were reported using the GRADE approach. The primary outcome was total blood loss. Secondary outcomes included patient reported outcome measures, adverse events, and rate of blood transfusion. Results. Eight RCTs were included in the systematic review and data from 7 of these studies pooled in the meta-analysis. A total of 708 patients were randomized across the studies (406 received TXA, 302 received placebo). Studies included patients undergoing anatomic or reverse total shoulder arthroplasty, open Latarjet surgery, and arthroscopic rotator cuff repair. Pooled analysis demonstrated significant reduction in perioperative bleeding with TXA compared to controls; estimated total blood loss (mean difference [MD], −209.66; 95% CI −389.11 to −30.21; p=0.02), and post-operative blood loss (via drain output) (MD, −84.8ml; 95% CI, −140.04 to −29.56; p=0.003). A mean difference in Visual Analogue Scale (VAS) of 2.93 was noted in favour of TXA (95% CI 0.2 to 5.66; p=0.04). Conclusions. Whilst noting some risk of bias within the studies, TXA was effective in reducing blood loss and pain in shoulder surgery. There may be a benefit of TXA use in both open and arthroscopic shoulder procedures. Larger, low risk of bias, RCTs for specific surgical shoulder procedures are required

Aims. The aims of this network meta-analysis (NMA) were to examine nonunion rates and functional outcomes following various operative and nonoperative treatments for displaced mid-shaft clavicle fractures. Methods. Initial search strategy incorporated MEDLINE, PubMed, Embase, and the Cochrane Library for relevant randomized controlled trials (RCTs). Four treatment arms were created: nonoperative (NO); intramedullary nailing (IMN); reconstruction plating (RP); and compression/pre-contoured plating (CP). A Bayesian NMA was conducted to compare all treatment options for outcomes of nonunion, malunion, and function using the Disabilities of the Arm Shoulder and Hand (DASH) and Constant-Murley Shoulder Outcome scores. Results. In all, 19 RCTs consisting of 1,783 clavicle fractures were included in the NMA. All surgical options demonstrated a significantly lower odds ratio (OR) of nonunion in comparison to nonoperative management: CP versus NO (OR 0.08; 95% confidence interval (CI) 0.04 to 0.17); IMN versus NO (OR 0.07; 95% CI 0.02 to 0.19); RP versus NO (OR 0.07; 95% CI: 0.01 to 0.24). Compression plating was the only treatment to demonstrate significantly lower DASH scores relative to NO at six weeks (mean difference -10.97; 95% CI -20.69 to 1.47). Conclusion. Surgical fixation demonstrated a lower risk of nonunion compared to nonoperative management. Compression plating resulted in significantly less disability early after surgery compared to nonoperative management. These results demonstrate possible early improved functional outcomes with compression plating compared to nonoperative treatment. Surgical fixation of mid-shaft clavicle fractures with compression plating may result in quicker return to activity by rendering patients less disabled early after surgery. Cite this article: Bone Jt Open 2021;2(8):646–654

The aim was to analyze the efficacy of zoledronic acid (ZA) versus denosumab in the prevention of pathological fractures in patients with bone metastases from advanced cancers by evaluating all available randomized controlled trials (RCTs) on this subject. A systematic search of electronic databases (PubMed and MEDLINE) was performed to identify all published RCTs comparing zoledronic acid with denosumab in prevention of pathological fractures in bone metastases. Risk of bias of the studies was assessed. The primary outcomes evaluated were pathological fractures. Four RCTs (7320 patients) were included. Denosumab was superior to ZA in reducing the likelihood of pathological fractures, when all tumour types were combined (OR 0.86, 95% CI [0.74, 0.99], p = 0.04). Denosumab was not significantly favoured over ZA in endodermal origin (breast and prostate) (OR 0.85, 95% CI [0.68, 1.05], p = 0.13) and mesodermal origin tumours (solid tumours and MM) (OR 0.87, 95% CI [0.71, 1.06], p = 0.16). Denosumab significantly reduces the likelihood of pathological fractures in comparison to ZA in patients with bone metastases. When pathological fractures were grouped by tumour origin (endodermal or mesodermal), there was no significant difference between denosumab and ZA. Further long-term studies are needed to confirm the effectiveness of these treatment regimens

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

Background. Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review. Method. Population, context, selection criteria, intervention(s), control, outcome measures, how the intervention was hypothesised to produce outcomes and author recommendations based on results of the study were extracted from text records. The extent to which the advice included matched a published international consensus statement on evidence-based advice for back pain was recorded. Whether interventions or settings were complex was determined using the Medical Research Council complex intervention development and evaluation guidance and the extent to which they met complexity reporting criteria was recorded. Results. The review included 26 trials conducted over 25 years. Differences In causal pathways could explain diversity in intervention design but these were not clearly described or evaluated. All studies were complex in terms of intervention and setting. This was rarely considered in intervention and trial design or when discussing the results. Although interventions were frequently described in detail only a few explained the process and justification of the design. Theories of education or behaviour change were rarely applied. Conclusion. These studies have not deepened our understanding of how education improves outcomes. Future RCTs should engage more with theory and other theory-based research methods should to be considered. Conflict of interest: No conflicts of interest. Sources of funding: No funding

Telemedicine is the delivery of healthcare from a remote location using integrated computer/communication technology. This systematic review aims to explore evidence for telemedicine in orthopaedics to determine its advantages, validity, effectiveness and utilisation particularly during our current pandemic where patient contact is limited. Databases of PubMed, Scopus and CINHAL were systematically searched and articles were included if they involved any form of telephone or video consultation in an orthopaedic population. Findings were synthesised into four themes: patient/clinician satisfaction, accuracy and validity of examination, safety and patient outcomes and cost effectiveness. Quality assessment was undertaken using Cochrane and Joanna Briggs Institute appraisal tools. Twenty studies were included consisting of nine RCTs across numerous orthopaedic subspecialties including fracture care, elective orthopaedics and oncology. Studies revealed high patient satisfaction with telemedicine for convenience, less waiting and travelling time. Telemedicine was cost effective particularly if patients had to travel long distances, required hospital transport or time off work. No clinically significant differences were found in patient examination nor measurement of patient reported outcome measures. Telemedicine was reported to be a safe method of consultation. However, studies were of variable methodological quality with selection bias. In conclusion, evidence suggests that telemedicine in orthopaedics can be safe, cost effective, valid in clinical assessment with high patient/clinician satisfaction. Further work with high quality RCTs is required to elucidate long term outcomes. This systematic review presents up-to-date evidence on the use of telemedicine and provides data for organisations considering its use in the current COVID-19 pandemic and beyond

This study aims to compare the outcomes of Volar locking plating (VLP) versus percutaneous Kirschner wires (K-wire) fixation for surgical management of distal radius fractures. We systematically searched multiple databases, including MEDLINE for randomized controlled trials (RCTs) comparing outcomes of VLP fixation and K-wire for treatment of distal radius fracture in adults. The methodological quality of each study was assessed by the Cochrane Risk of Bias tool. Patient-reported outcomes, functional outcomes, and complications at 1 year follow up were evaluated. Meta-analysis was performed using random-effects models and results presented as risk ratios (RRs) or mean differences (MDs) with 95% confidence interval (CI). 13 RCTs with 1336 participants met the inclusion criteria. Disabilities of the Arm, Shoulder and Hand (DASH) scores were significantly better for VLP fixation (MD= 2.15; 95% CI, 0.56-3.74; P = 0.01; I2=23%). No significant difference between the two procedures for grip strength measured in kilograms (MD= −3.84; 95% CI,-8.42-0.74; P = 0.10; I2=52%) and Patient-Rated Wrist Evaluation (PRWE) scores (MD= −0.06; 95% CI,-0.87-0.75; P = 0.89; I2=0%). K-wire treatment yielded significantly improved extension (MD= −4.30; P=0.04) but with no differences in flexion, pronation, supination, and radial deviation (P >0.05). The risk of complications and rate of reoperation were similar for the two procedures (P >0.05). This meta-analysis suggests that VLP fixation improves DASH score at 12 months follow up, however, the difference is small and unlikely to be clinically important. Existing literature does not provide sufficient evidence to demonstrate the superiority of either VLP or K-wire treatment in terms of patient-reported outcomes, functional outcomes, and complications

To determine in skeletally mature patients with a traumatic, first-time, patellar dislocation, the effect of early MPFL reconstruction versus rehabilitation on the rate of recurrent patellar dislocations and functional outcomes. Three online databases MEDLINE, EMBASE and PubMed were searched from database inception (1946, 1974, 1966 respectively), to August 20th, 2021, for literature addressing the management of patients sustaining acute first-time patellar dislocations. Data on redislocation rates, functional outcomes using the Kujala score, and complication rates were recorded. A meta-analysis was used to pool the mean postoperative kujala score as well as calculate the proportion of patients sustaining redislocation episodes using a random effects model. A risk of bias assessment was performed for all included studies using the MINORS and Detsky scores. Overall, there were a total of 22 studies and 1705 patients included in this review. The pooled mean redislocation rate in 18 studies comprising 1409 patients in the rehabilitation group was 31% (95% CI 25%-36%, I2 = 65%). Moreover, the pooled mean redislocation rate in five studies comprising 318 patients undergoing early MPFL reconstruction was 7% (95% CI 2%-17%, I2 = 70%). The pooled mean postoperative Kujala anterior knee pain score in three studies comprising 67 patients in the reconstructive group was 91 (95% CI 84-97, I2 = 86%), compared to a score of 81 (95% CI 78-85, I2 = 78%) in 7 studies comprising 332 patients in the rehabilitation group. The reoperation rate was 9.0% in 936 patients in the rehabilitation group and 2.2% in 322 patients in the reconstruction group. Management of acute first-time patellar dislocations with MPFL reconstruction resulted in a lower rate of redislocation and a higher Kujala score, as well as noninferiority with respect to complication rates compared to nonoperative treatment. The paucity of high-level evidence warrants further investigation in this topic in the form of well-designed and high-powered RCTs to determine the optimal management option in these patients

Background. Exercise is a complex intervention, and often has more than one treatment target. Results from randomised controlled trials (RCTs) of exercise interventions for chronic low back pain (CLBP) typically show small to moderate effect sizes, but these may differ where outcomes better reflect the targets of interventions. This review aimed to describe what treatment targets, outcome domains and primary outcome measures are used in exercise RCTs, and examined how well the selected outcome domains match the treatment targets used in each RCT. Methods and Results. A computer-aided literature search was performed in eight databases, from inception to August 2018. Inclusion criteria: RCTs in CLBP, exercise compared to a non-exercise arm, sample size >60 per arm. Title and abstract review, subsequent full text review, data extraction and risk of bias assessment were independently undertaken by pairs of reviewers. Of 18251 initially identified titles and abstracts, 23 trials were included in the review. 30 treatment targets were extracted, and 6 primary outcome domains identified. A logic model of the treatment targets and outcomes demonstrated diverse relationships. Only 5 RCTs matched their primary outcome domain to the identified treatment targets, 12 used primary outcomes that did not match the reported treatment targets, and 6 were partially matched. Conclusion. The majority of included trials did not match the primary outcome domain to the treatment targets of the exercise intervention. Further research will explore if better matching between treatment targets and outcomes may change the conclusions of exercise trials in CLBP. No conflicts of interest. Sources of Funding: This PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

Aims. Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. Methods. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. Results. We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). Conclusion. TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830–839

We conducted a meta-analysis, including randomised controlled trials (RCTs) and cohort studies, to examine the effect of patient-specific instruments (PSI) on radiological outcomes after total knee replacement (TKR) including: mechanical axis alignment and malalignment of the femoral and tibial components in the coronal, sagittal and axial planes, at a threshold of > 3º from neutral. Relative risks (RR) for malalignment were determined for all studies and for RCTs and cohort studies separately. Of 325 studies initially identified, 16 met the eligibility criteria, including eight RCTs and eight cohort studies. There was no significant difference in the likelihood of mechanical axis malalignment with PSI versus conventional TKR across all studies (RR = 0.84, p = 0.304), in the RCTs (RR = 1.14, p = 0.445) or in the cohort studies (RR = 0.70, p = 0.289). The results for the alignment of the tibial component were significantly worse using PSI TKR than conventional TKR in the coronal and sagittal planes (RR = 1.75, p = 0.028; and RR = 1.34, p = 0.019, respectively, on pooled analysis). PSI TKR showed a significant advantage over conventional TKR for alignment of the femoral component in the coronal plane (RR = 0.65, p = 0.028 on pooled analysis), but not in the sagittal plane (RR = 1.12, p = 0.437). Axial alignment of the tibial (p = 0.460) and femoral components (p = 0.127) was not significantly different. We conclude that PSI does not improve the accuracy of alignment of the components in TKR compared with conventional instrumentation. Cite this article: Bone Joint J 2014; 96-B:1052–61

Dislocation post THA confers a higher risk of re-dislocation (Kotwal et al, 2009). The dual mobility (DM) cup design (1974) was aimed at improving the stability by increasing the femoral head to neck ratio (Cuthbert et al., 2019) combining the ideas of low friction arthroplasty with increased jump distance associated with a big head arthroplasty. Understand the dislocation rates, rates of aseptic loosening, infection rate and revision rates between the 2 types of constructs to provide current and up-to date evidence. Medline, pubmed, embase and Cochrane databases were used based on PRISMA guidelines. RevMan software was used for the meta-analysis. Studies (English literature) which used DM construct with atleast 6 months follow-up used as intervention and non DM construct as control were included. 2 independent reviewers conducted the review with a third reviewer in case of difference in opinion regarding eligibility. Primary outcome was dislocation rate and secondary outcome was rate of revision. 564 articles identified out of which 44 articles were screened for full texts and eventually 4 systematic review articles found eligible for the study. Thus, study became a review of systematic reviews. From the 4 systematic reviews, another 35 studies were identified for data extraction and 13 papers were used for meta-analysis. Systematic reviews evaluated, projected an average follow up of 6-8 years with significantly lower dislocation rates for DM cups. The total number of patients undergoing DM cup primary THA were 30,559 with an average age 71 years while the control group consisted of 218,834 patients with an average age of 69 years. DM group had lower rate of dislocation (p < 0.00001), total lower rate of cup revision (p < 0.00001, higher incidence of fracture (p>0.05). DM THA is a viable alternative for conventional THA. The long-term results of DM cups in primary THA need to be further evaluated using high quality prospective studies and RCTs

Aims. The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease. Methods. A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed. Results. Ten RCTs with 713 patients and 3,331 pedicle screws were included. Compared with CT, the accuracy rate of RA was superior in Grade A with statistical significance and Grade A + B without statistical significance. Compared with CT, the operating time of RA was longer. The difference between RA and CT was statistically significant in radiation dose. Proximal facet joint violation occurred less in RA than in CT. The postoperative Oswestry Disability Index (ODI) of RA was smaller than that of CT, and there were some interesting outcomes in our subgroup analysis. Conclusion. RA technique could be viewed as an accurate and safe pedicle screw implantation method compared to CT. A robotic system equipped with optical intraoperative navigation is superior to CT in accuracy. RA pedicle screw insertion can improve accuracy and maintain stability for some challenging areas. Cite this article: Bone Joint Res 2020;9(10):653–666

Patients undergoing total hip or knee arthroplasty (THA/TKA) are commonly associated with high pain scores and narcotic use. Duloxetine is effective in relieving chronic pain. The aim of this study was to evaluate the safety and efficacy of duloxetine for pain management following THA/TKA. Five major databases (PubMed, Embase, Scopus, Cochrane, and Web of Science) were searched for randomised controlled trials (RCTs) that compared duloxetine to placebo in patients that underwent THA/TKA. The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of analgesics, length of stay, and safety profile. The risk of bias was assessed using the Cochrane tool. Data were pooled using RevMan 5.4. The results were reported as mean difference (MD) or standardised MD (SMD) and 95% confidence intervals (CI). Eight RCTs with 767 patients were included. 50.2% (n=385/767) of patients received duloxetine. After one day, duloxetine was superior to the control regarding pain reduction with rest (SMD= −0.22 [−0.41, −0.03], p=0.02) after sensitivity analysis and pain reduction at movement (SMD= −0.39 [−0.55, −0.24], p<0.001). Similarly, after 12 weeks, duloxetine significantly reduced pain with rest (SMD= −0.3 [−0.52, −0.09], p=0.006) and pain with movement (SMD= −0.52 [−0.87, −0.17], p=0.003). In addition, after sensitivity analysis, duloxetine was associated with less analgesic use after one day (MD= −4.65 [−7.3, −2.01], p<0.001) and two days (MD= −5.65 [−10.62, −0.67], p=0.03). Patients who received duloxetine also required fewer analgesics after three days. However, there was no significant difference between the duloxetine and control groups in analgesic use after one week, length of stay, and adverse events. Duloxetine was superior to the placebo regarding short-term and long-term pain reduction with rest and movement following THA/TKA. Duloxetine reduced postoperative analgesic use. There was no significant difference between duloxetine and placebo regarding adverse events and length of stay

Abstract. Introduction. Dislocation post THA confers a higher risk of re-dislocation (Kotwal et al, 2009). The dual mobility (DM) cup design (1974) was aimed at improving the stability by increasing the femoral head to neck ratio (Cuthbert et al., 2019) combining the ideas of low friction arthroplasty with increased jump distance associated with a big head arthroplasty. Aims. Understand the dislocation rates, rates of aseptic loosening, infection rate and revision rates between the 2 types of constructs to provide current and up-to date evidence. Methods. Medline, pubmed, embase and Cochrane databases were used based on PRISMA guidelines. RevMan software was used for the meta-analysis. Studies (English literature) which used DM construct with atleast 6 months follow-up used as intervention and non DM construct as control were included. 2 independent reviewers conducted the review with a third reviewer in case of difference in opinion regarding eligibility. Primary outcome was dislocation rate and secondary outcome was rate of revision. Results. 564 articles identified out of which 44 articles were screened for full texts and eventually 4 systematic review articles found eligible for the study. Thus, study became a review of systematic reviews. From the 4 systematic reviews, another 35 studies were identified for data extraction and 13 papers were used for meta-analysis. Systematic reviews evaluated, projected an average follow up of 6–8 years with significantly lower dislocation rates for DM cups. The total number of patients undergoing DM cup primary THA were 30,559 with an average age 71 years while the control group consisted of 218,834 patients with an average age of 69 years. DM group had lower rate of dislocation (p < 0.00001), total lower rate of cup revision (p < 0.00001, higher incidence of fracture (p>0.05). Conclusion. DM THA is a viable alternative for conventional THA. The long-term results of DM cups in primary THA need to be further evaluated using high quality prospective studies and RCTs. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Fragility ankle fractures are traditionally managed conservatively or with open reduction internal fixation (ORIF). Tibiotalocalcaneal (TTC) fusion is an alternative option for the geriatric patient. This systematic review and meta-analysis provides a detailed analysis of the functional and clinical outcomes of hindfoot nailing for fragility ankle fractures presented so far in the literature. A systematic search was performed on MEDLINE, EMBASE, Cochrane Library, Scopus, Web of Science, identifying fourteen studies for inclusion. Studies including patients over 60 with a fragility ankle fracture, treated with TTC nail were included. Patients with a previous fracture of the ipsilateral limb, fibular nails, and pathological fractures were excluded. Subgroup analyses were performed according to (1) open vs closed fractures, (2) immediate post-operative FWB vs post-operative NWB, (3) majority of cohort are diabetics vs minority of cohort are diabetics. Meta-regression analyses were done to explore sources of heterogeneity, and publication bias was assessed using Egger's test. The pooled proportion of superficial infection, deep infection, implant failure, malunion, and all-cause mortality was 0.10 (95%CI:0.06-0.16; I2=44%), 0.08 (95%CI:0.06-0.11, I2=0%), 0.11 (95%CI:0.07-0.15, I2=0%), 0.11 (95%CI:0.06-0.18; I2=51%), and 0.27 (95%CI:0.20-0.34; I2=11%), respectively. The pooled mean post-operative OMAS score was 54.07 (95%CI:48.98-59.16; I2=85%). The best-fitting meta-regression model included age and percentage of male patients as covariates (p=0.0263), and were inversely correlated with higher OMAS scores. Subgroup analyses showed that studies with a majority of diabetics had a higher proportion of implant failure (p=0.0340) and surgical infection (p=0.0096), and a lower chance of returning to pre-injury mobility than studies with a minority of diabetics (p=0.0385). Egger's test (p=0.56) showed no significant publication bias. TTC nailing is an adequate alternative option for fragility ankle fractures. However, current evidence includes mainly case series with inconsistent outcome measures reported and post-operative rehabilitation protocols. Prospective RCTs with long follow-up times and large cohort sizes are needed to clearly guide the use of TTC nailing for ankle fractures

Aims. Our purpose was to determine the quality of current randomised controlled trials (RCTs) in hand surgery using standardised metrics. Materials and Methods. Based on five-year mean impact factors, we selected the six journals that routinely publish studies of upper extremity surgery. Using a journal-specific search query, 62 RCTs met our inclusion criteria. Then three blinded reviewers used the Jadad and revised Coleman Methodology Score (RCMS) to assess the quality of the manuscripts. Results. Based on the Jadad scale, 28 studies were of high quality and 34 were of low quality. Methodological deficiencies in poorly scoring trials included the absence of rate of enrolment, no power analysis, no description of withdrawal or dropout, and a failure to use validated outcomes assessments with an independent investigator. Conclusion. A large number of RCTs in hand, wrist, and elbow surgery were of suboptimal quality when judged against the RCMS and Jadad scales. Even with a high level of evidence, study design and execution of RCTs should be critically assessed. Methodological deficiencies may introduce bias and lead to statistically underpowered studies. Cite this article: Bone Joint J 2017;99-B:94–9

Aims. This study reviews the past 30 years of research from the Canadian Orthopedic Trauma Society (COTS), to identify predictive factors that delay or accelerate the course of randomized controlled trials in orthopaedic trauma. Methods. We conducted a methodological review of all papers published through the Canadian Orthopaedic Trauma Society or its affiliates. Data abstracted included: year of publication; journal of publication; study type; number of study sites; sample size; and achievement of sample size goals. Information about the study timelines was also collected, including: the date of study proposal to COTS; date recruitment began; date recruitment ended; and date of publication. Results. In total, 22 studies have been published through the COTS working group, 13 of which are randomized controlled trials (RCTs). In total, 1,423 individual patients have been involved in COTS studies, a mean of 110 patients per trial (22 to 424). Each study was conducted across a mean of approximately six centres (1 to 11) and took nearly ten years (mean 119.9 months (59 to 188)) from presentation of concept to publication. The mean length of enrolment was 63 months (26 to 113) and the mean time from cessation of enrolment to publication 51 months (19 to 78). Regardless of sample size, the only factor associated with a decreased length of enrolment was a higher number of clinical sites (p = 0.041). Neither study sample size nor length of enrolment were associated with total time to publication. Conclusion. Over the last three decades, COTS has developed a multinational strategy to produce high-quality evidence in the field of orthopaedic trauma through 13 multicentre RCTs. Future efficiencies can be realized by recruitment of more clinical sites, improving connectivity between the sites, and the promotion of national streamlined ethics processes. Cite this article: Bone Joint J 2021;103-B(5):898–901

We hypothesised that a large acromial cover with an upwardly tilted glenoid fossa would be associated with degenerative rotator cuff tears (RCTs), and conversely, that a short acromion with an inferiorly inclined glenoid would be associated with glenohumeral osteoarthritis (OA). This hypothesis was tested using a new radiological parameter, the critical shoulder angle (CSA), which combines the measurements of inclination of the glenoid and the lateral extension of the acromion (the acromion index). The CSA was measured on standardised radiographs of three groups: 1) a control group of 94 asymptomatic shoulders with normal rotator cuffs and no OA; 2) a group of 102 shoulders with MRI-documented full-thickness RCTs without OA; and 3) a group of 102 shoulders with primary OA and no RCTs noted during total shoulder replacement. The mean CSA was 33.1° (26.8° to 38.6°) in the control group, 38.0° (29.5° to 43.5°) in the RCT group and 28.1° (18.6° to 35.8°) in the OA group. Of patients with a CSA > 35°, 84% were in the RCT group and of those with a CSA < 30°, 93% were in the OA group. We therefore concluded that primary glenohumeral OA is associated with significantly smaller degenerative RCTs with significantly larger CSAs than asymptomatic shoulders without these pathologies. These findings suggest that individual quantitative anatomy may imply biomechanics that are likely to induce specific types of degenerative joint disorders. Cite this article: Bone Joint J 2013;95-B:935–41

The aim was to analyze whether non-steroidal anti-inflammatory drugs (NSAIDs) have an adverse effect on bone healing by evaluating all available human randomized controlled trials (RCTs) on this subject. A systematic search of electronic databases (PubMed, MEDLINE, and Cross-References) was performed to identify RCTs comparing the occurrence of nonunion in patients who received NSAIDs to the control group. Risk of bias of the studies was assessed. Nonunion was the main outcome evaluated, however, regression analysis was used to estimate the relative risk comparing duration and type of NSAIDs. Six RCTs (609 patients) were included. The risk of nonunion was higher in the patients given NSAIDs after the fracture (P-value= 0.0009, relative risk [RR] = 2.9, 95% confidence interval [CI] = 1.6 to 6.3). However, once the studies have been categorized to the duration of NSAIDs, those who received short period of NSAIDs (4 weeks) (P-value = 0.0002, RR = 4.1, CI = 2.1 to 8). Also, indomethacin agent has associated with high nonunion (P-value = 0.0001, RR = 3.9, CI = 2.3 to 13.9) compared to other NSAIDs which did not show a nonunion risk (P-value = 0.24, RR = 2.3, CI = 0.6 to 8.9). Using NSAIDs for long period (> 4 weeks) after fracture is significantly associated with nonunion especially with indomethacin agent. However, short period of NSAIDs (< 2 weeks) did not show the adverse effects of nonunion. Overall, further studies are required to support our conclusion

Background and Purpose. The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs. Methods. Two online cross-sectional surveys distributed via UK and Australian professional networks to clinicians involved in LBP care, collected data on clinical discipline, practice setting and preferred care of five patient cases (ranging in age, pain duration, BMI, imaging findings, neurological signs/symptoms). Clinicians were also asked about willingness to randomise each patient case. Results. Of 174 responses (73 UK, 101 Australia), 70 were orthopaedic surgeons, 34 neurosurgeons, 65 allied health professionals (AHPs), 5 others. Most worked in public health services only (92% UK, 45% Australia), or a mix of public/private (36% Australia). Most respondents chose BCC as their first-choice management option for all five cases (81–93% UK, 83–91% Australia). For LFS, UK surgeons preferred TLIF (36.4%), whereas Australian surgeons preferred ALIF (54%). Willingness to randomise cases ranged from 37–60% (UK mean 50.7%), and 47–55% (Australian mean 51.9%); orthopaedic and neuro-surgeons were more willing than AHPs. Conclusion. Whilst BCC was preferred for all five patient cases, just over half of survey respondents in both the UK and Australia were willing to randomise cases to either LFS or BCC, indicating clinical equipoise (collective uncertainty) needed for RCT recruitment. Conflicts of interest. None. Sources of funding. No specific funding obtained for the surveys. DB, SA, AG and NEF have funding from the National Institute for Health Research (NIHR) UK (FORENSIC-UK NIHR134859); NEF, DB and SA have funding from the Australian National Health and Medical Research Council (NHMRC FORENSIC-Australia GA268233). AG has funding from Orthopaedic Research UK (combined with British Association of Spine Surgeons and British Scoliosis Society) and Innovate UK. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182)

Lung cancer is the most common cancer diagnosed, the leading cause of cancer-related deaths, and bone metastases occurs in 20–40% of lung cancer patients. They often present symptomatically with pain or skeletal related events (SREs), which are independently associated with decreased survival. Bone modifying agents (BMAs) such as Denosumab or bisphosphonates are routinely used, however no specific guidelines exist from the National Comprehensive Cancer Center or the European Society of Medical Oncologists. Perhaps preventing the formation of guidelines is the lack of a high-quality quantitative synthesis of randomized controlled trial (RCT) data to determine the optimal treatment for the patient important outcomes of 1) Overall survival (OS), 2) Time to SRE, 3) SRE incidence, and 4) Pain Resolution. The objective of this study was to perform the first systematic review and network meta-analysis (NMA) to assess the best BMA for treatment of metastatic lung cancer to bone. We conducted our study in accordance to the PRISMA protocol. We performed a librarian assisted search of MEDLINE, PubMed, EMBASE, and Cochrane Library and Chinese databases including CNKI and Wanfang Data. We included studies that are RCTs reporting outcomes specifically for lung cancer patients treated with a bisphosphonate or Denosumab. Screening, data extraction, risk of bias and GRADE were performed in duplicate. The NMA was performed using a Bayesian probability model with R. Results are reported as relative risks, odds ratios or mean differences, and the I2 value is reported for heterogeneity. We assessed all included articles for risk of bias and applied the novel GRADE framework for NMAs to rate the quality of evidence supporting each outcome. We included 132 RCTs comprising 11,161 patients with skeletal metastases from lung cancer. For OS, denosumab was ranked above zoledronic acid (ZA) and estimated to confer an average of 3.7 months (95%CI: −0.5 – 7.6) increased survival compared to untreated patients. For time to SRE, denosumab was ranked first with an average of 9.1 additional SRE-free months (95%CI: 4.0 – 14.0) compared to untreated patients, while ZA conferred an additional 4.8 SRE-free months (2.4 – 7.0). Patients treated with the combination of Ibandronate and systemic therapy were 2.3 times (95%CI: 1.7 – 3.2) more likely to obtain successful pain resolution, compared to untreated. Meta-regression showed no effect of heterogeneity length of follow-up or pain scales on the observed treatment effects. Heterogeneity in the network was considered moderate for overall survival and time to SRE, mild for SRE incidence, and low for pain resolution. While a generally high risk of bias was observed across studies, whether they were from Western or Chinese databases. The overall GRADE for the evidence underlying our results is High for Pain control and SRE incidence, and Moderate for OS and time to SRE. This study represents the most comprehensive synthesis of the best available evidence guiding pharmacological treatment of bone metastases from lung cancer. Denosumab is ranked above ZA for both overall survival and time to SRE, but both treatments are superior to no treatment. ZA was first among all bisphosphonates assessed for odds of reducing SRE incidence, while the combination of Ibandronate and radionuclide therapy was most effective at significantly reducing pain from metastases. Clinicians and policy makers may use this synthesis of all available RCT data as support for the use of a BMA in MBD for lung cancer

Introduction. Treatment of non-union in open tibial fractures Gustilo-Anderson(GA)-3A/3B fractures remains a challenging problem. Most of these can be dealt using treatment methods that requires excision of the non-union followed by bone grafting, masquelet technique, or acute shortening. Circular fixators with closed distraction or bone transport also remains a useful option. However, sometimes due to patient specific factors these cannot be used. Recently antibiotic loaded bone substitutes have been increasingly used for repairing infected non-unions. They provide local antibiotic delivery, fill dead space, and act as a bone conductive implant, which is resorted at the end of a few months. We aimed to assess the outcome of percutaneous injection of bone substitute while treating non-union of complex open tibial fractures. Materials & Methods. Three cases of clinical and radiological stiff tibial non-union requiring further intervention were identified from our major trauma open fracture database. Two GA-3B cases, treated with a circular frame developed fracture-related-infection(FRI) manifesting as local cellulitis, loosened infected wires/pins with raised blood-markers, and one case of GA-3A treated with an intramedullary nail. At the time of removal of metalwork/frame, informed consent was obtained and Cerament-G. TM. (bone-substitute with gentamicin) was percutaneously injected through a small cortical window using a bone biopsy(Jamshedi needle). All patients were allowed to weight bear as tolerated in a well-fitting air-cast boot and using crutches. They were followed up at 6 weekly intervals with clinical assessment of their symptoms and radiographs. Fracture union was assessed using serial radiographs with healing defined as filling of fracture gap, bridging callus and clinical assessment including return to full painless weight bearing. Results. Follow-up at 6 months showed all fractures had healed with no defect or gaps with evidence of new trabecular bone and significant resorption of Cerament-G. TM. at final follow-up. There was no evidence of residual infection with restoration of normal limb function. Fractures with no internal fixation showed a mild deformity that had developed during the course of the healing, presumed due to mild collapse in the absence of fixation. These were less than 10 degrees in sagittal and coronal planes and were clinically felt to be insignificant by the patients. Conclusions. Cerament-G's unique combination of high dose antibiotics and hydroxy apatite matrix provided by calcium sulphate might help provide an osteoconductive environment to allow these stiff non-unions to heal. The matrix appears to provide a scaffold-like structure that allows new bone in-growth with local release of antibiotics helping reduce deep-seated infections. The final deformation at fracture site underlines the need for fixation- and it is very unlikely that this technique will work in mobile nonunions. Whilst similar fractures may heal without the use of bone substitute injections, the speed of healing in presence of significant fracture gap suggests the use of these bone substitutes did help in our cases. Further studies with a larger cohort, including RCTs, to evaluate the effectiveness of this technique compared to other methods are needed

Aims. We conducted a systematic review and meta-analysis to compare the mortality, morbidity, and functional outcomes of cemented versus uncemented hemiarthroplasty in the treatment of intracapsular hip fractures, analyzing contemporary and non-contemporary implants separately. Methods. PubMed, Medline, EMBASE, CINAHL, and Cochrane Library were searched to 2 February 2020 for randomized controlled trials (RCTs) comparing the primary outcome, mortality, and secondary outcomes of function, quality of life, reoperation, postoperative complications, perioperative outcomes, pain, and length of hospital stay. Relative risks (RRs) and mean differences (with 95% confidence intervals (CIs)) were used as summary association measures. Results. A total of 18 studies corresponding to 16 non-overlapping RCTs with a total of 2,819 intracapsular hip fractures were included. Comparing contemporary cemented versus uncemented hemiarthroplasty, RRs (95% CIs) for mortality were 1.32 (0.44 to 3.99) perioperatively, 1.01 (0.48 to 2.10) at 30 days, and 0.90 (0.71 to 1.15) at one year. The use of contemporary cemented hemiarthroplasty reduced the risk of intra- and postoperative periprosthetic fracture. There were no significant differences in the risk of other complications, function, pain, and quality of life. There were no significant differences in perioperative outcomes except for increases in operating time and overall anaesthesia for contemporary cemented hemiarthroplasty with mean differences (95% CIs) of 6.67 (2.65 to 10.68) and 4.90 (2.02 to 7.78) minutes, respectively. The morbidity and mortality outcomes were not significantly different between non-contemporary cemented and uncemented hemiarthroplasty. Conclusion. There are no differences in the risk of mortality when comparing the use of contemporary cemented with uncemented hemiarthroplasty in the management of intracapsular hip fractures. Contemporary cemented hemiarthroplasty is associated with a substantially lower risk of intraoperative and periprosthetic fractures. Cite this article: Bone Joint J 2020;102-B(9):1113–1121

Purpose and Background: Reliable and valid RCTs are essential in guiding clinical practice, but shortcomings in methodological quality have been reported in RCTs on LBP. The aim of this paper was to use the results of a systematic review on exercise or manual therapies for persistent LBP to evaluate the effect of methodological quality, sample size and statistical rigour on the outcomes of these trials. Methods and Results: The systematic review included 41 RCTs on exercise or manual therapies (i.e. manipulation, mobilisation and/or massage) for persistent (> 6 weeks) non-specific LBP. Quality of the RCTs was assessed using an adapted 10-point Van Tulder scale. Sample size was defined as the number of subjects in the intervention group. Adequate statistical testing was defined as analyses that compared the change in pain or function achieved by the intervention group with the change in the same parameter achieved by the control or alternative group. The results showed that the RCTs with smaller sample sizes or RCTs of lower methodological quality more often reported larger differences in effectiveness than RCTs of higher methodological quality or larger sample sizes. Furthermore, small differences in effectiveness reported by smaller RCTs were often not statistically significant, while larger trials showed that such differences actually were statistically significant. Conclusion: Low methodological quality and small sample size has resulted in misinterpretation of RCTs. Small or low quality RCTs overestimated differences in effectiveness or failed to detect smaller but statistically significant differences. Future RCTs and systematic reviews should address these shortcomings in order to provide reliable guidance for clinical practice

Aims. Flail chest from a blunt injury to the thorax is associated with significant morbidity and mortality. Its management globally is predominantly non-operative; however, there are an increasing number of centres which undertake surgical stabilisation. The aim of this meta-analysis was to compare the efficacy of this approach with that of non-operative management. Patients and Methods. A systematic search of the literature was carried out to identify randomised controlled trials (RCTs) which compared the clinical outcome of patients with a traumatic flail chest treated by surgical stabilisation of any kind with that of non-operative management. Results. Of 1273 papers identified, three RCTs reported the results of 123 patients with a flail chest. Surgical stabilisation was associated with a two thirds reduction in the incidence of pneumonia when compared with non-operative management (risk ratio 0.36, 95% confidence interval (CI) 0.15 to 0.85, p = 0.02). The duration of mechanical ventilation (mean difference -6.30 days, 95% CI -12.16 to -0.43, p = 0.04) and length of stay in an intensive care unit (mean difference -6.46 days, 95% CI 9.73 to -3.19, p = 0.0001) were significantly shorter in the operative group, as was the overall length of stay in hospital (mean difference -11.39, 95% CI -12.39 to -10.38, p < 0.0001). Conclusion. Surgical stabilisation for a traumatic flail chest is associated with significant clinical benefits in this meta-analysis of three relatively small RCTs. Cite this article: Bone Joint J 2016;98-B:1119–25

Background. Routine imaging (radiography, CT, MRI) provides no health benefits for low back pain (LBP) patients and is not recommended in clinical practice guidelines. Whether imaging leads to increased costs, healthcare utilization or absence from work is unclear. Purpose. To systematically review if imaging in patients with LBP increases costs, leads to higher health care utilization or increases absence from work. METHODS. Randomized controlled trials (RCTs) and observational studies (OSs), comparing imaging versus no imaging on targeted outcomes were extracted from medical databases until October 2017. Data extraction and risk of bias assessment was performed independently by two reviewers. The quality of the body of evidence was determined using GRADE methodology. Results. Moderate quality evidence (1 RCT; n=421) supports that direct costs increase for patients undergoing radiography. Low quality evidence (3 OSs; n=9535) supports that early MRI leads to a large increase in costs. Moderate quality evidence (2 RCTs, 6 OSs; n=19392) supports that performing MRI, radiography or CT is associated with increased healthcare utilization. Two RCTs (n=667) showed no significant differences between radiography or MRI groups compared with no imaging groups on absence from work. However, the results of two observational studies (n=7765) did show significantly greater absence from work in the imaging groups compared to the no imaging-groups. Conclusions. Imaging in LBP is associated with higher medical costs and increased healthcare utilisation. There are indications that it also leads to higher absence from work. No conflicts of interest. No funding obtained

Abstract. BACKGROUND. The effectiveness of anti-embolic graduated compression stockings (GCSs) has recently been questioned. The aim of this study is to systematically review all the relevant randomised controlled trials published to date. PATIENTS AND METHODS. We systematically reviewed all the randomised controlled trials comparing anti-embolism stockings with no stockings. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL, Cochrane Musculoskeletal Injuries Group specialized register and the reference lists of articles as well as hand search results. Trials were independently assessed and data for the main outcome measures; deep vein thrombosis (DVT), pulmonary embolism and skin ulceration, were extracted by two reviewers. RESULTS. A total of 26 relevant RCTs involving 8279 participants were systematically reviewed. Theoccurrence of deep vein thrombosis was 306/4159(7.3%) with the stocking to 492/4120(11.9%) without the stockings (RR 0.49, 95% CI 0.39–0.62). The occurrence of pulmonary embolism was also reduced from 1.2% go 0.7% (95% 0.33–0.92). This initial finding was unsound due to the potential underreporting of negative studies and the subsequent changes to clinical practice. For the three large contemporary studies involving 5171 participants, these failed to show any statistically significant reduction in thrombosis, with DVT confirmed in 158(6.1%) participants in those allocated to stocking, as opposed to 171(6.6%) in the control group. CONCLUSION. The current recommendations regarding the use of GCSs need to be reconsidered, as their effectiveness at reducing the occurrence of post-operative DVT is minimal at best, based on the current evidence and clinical practices

A literature review of bone graft substitutes for spinal fusion was undertaken from peer reviewed journals to form a basis for guidelines on their clinical use. A PubMed search of peer reviewed journals between Jan 1960 and Dec 2009 for clinical trials of bone graft substitutes in spinal fusion was performed. Emphasis was placed on RCTs. Small and duplicated RCTs were excluded. If no RCTs were available the next best clinical evidence was assessed. Data were extracted for fusion rates and complications. Of 929 potential spinal fusion studies, 7 RCTs met the inclusion criteria for BMP-2, 3 for BMP-7, 2 for Tricalcium Phosphate and 1 for Tricalcium Phosphate/Hydroxyapatite (TCP/HA). No clinical RCTs were found for Demineralised Bone Matrix (DBM), Calcium Sulphate or Calcium Silicate. There is strong evidence that BMP-2 with TCP/HA achieves similar or higher spinal fusion rates than autograft alone. BMP-7 achieved similar results to autograft. 3 RCTs support the use of TCP or TCP/HA and autograft as a graft extender with similar results to autograft alone. The best clinical evidence to support the use of DBMs are case control studies. The osteoinductive potential of DBM appears to be very low however. There are no clinical studies to support the use of Calcium Silicate. The current literature supports the use of BMP-2 with HA/TCP as a graft substitute. TCP or HA/TCP with Autograft is supported as a graft extender. There is not enough clinical evidence to support other bone graft substitutes. This study did not require ethics approval and no financial support was received

Introduction and Objective. The effectiveness of anti-embolic graduated compression stockings (GCSs) has recently been questioned. The aim of this study is to systematically review all the relevant randomised controlled trials published to date. Materials and Methods. We systematically reviewed all the randomised controlled trials comparing anti-embolism stockings with no stockings. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL, Cochrane Musculoskeletal Injuries Group specialized register and the reference lists of articles as well as hand search results. Trials were independently assessed and data for the main outcome measures; deep vein thrombosis (DVT), pulmonary embolism and skin ulceration, were extracted by two reviewers. Results. A total of 26 relevant RCTs involving 8279 participants were systematically reviewed. The occurrence of deep vein thrombosis was 306/4159 (7.3%) with the stocking to 492/4120 (11.9%) without the stockings (RR 0.49, 95% CI 0.39–0.62). The occurrence of pulmonary embolism was also reduced from 1.2% to 0.7% (95% 0.33–0.92). This initial finding was unsound due to the potential underreporting of negative studies and the subsequent changes to clinical practice. For the three large contemporary studies involving 5171 participants, these failed to show any statistically significant reduction in thrombosis, with DVT confirmed in 158 (6.1%) participants in those allocated to stocking, as opposed to 171 (6.6%) in the control group. Conclusions. The current recommendations regarding the use of thrombo-embolic stockings need to be reconsidered, as their effectiveness at reducing the occurrence of post-operative deep vein thrombosis is minimal at best, based on the current evidence and clinical practices

Background. To aid recovery, rehabilitation is an important adjunct to surgery. Acknowledging the MRC framework for complex interventions we assessed the evidence-base for components of comprehensive rehabilitation in total hip (THR) and total knee replacement (TKR) pathways. Methods. We conducted systematic reviews and meta-analyses of randomised controlled trials (RCT) of pre-surgical exercise and education, occupational therapy and post-operative physiotherapy. In feasibility RCTs we explored acceptability of pain self-management and occupational therapy before THR, and physiotherapy after TKR. We searched trial registers for ongoing RCTs. Results. Pre-surgical interventions. Systematic review identified 38 interventions targeting physical function before THR and TKR. Interventions showed functional benefit compared with controls, standardised mean difference (SMD) 0.32 (95% CI 0.20, 0.44; p<0.00001). In 27 studies targeting in-hospital recovery, intervention patients had lower anxiety, SMD 0.38 (95% CI 0.13, 0.63; p=0.003), and earlier mobilisation by 4 hours (95% CI 0.04, 0.30; p=0.009). In 20 studies, interventions targeting long-term recovery showed no benefit for function or pain. We randomised 88 patients into a feasibility RCT of group-based pain self-management. Attendees were highly satisfied but participation was low. Pre-operatively, many patients may perceive that only surgery can treat their symptoms. Occupational therapy. Systematic review identified 7 small RCTs in THR. Function improved in patients receiving occupational therapy, SMD 0.40 (95%CI 0.09, 0.70; p=0.01) but this was not sustained post-surgery. In our feasibility study with 44 patients randomised to pre-operative provision of aids and appliances or usual care, the intervention was delivered successfully and acceptable to participants. We identified no ongoing studies. Post-discharge physiotherapy. Systematic review identified 7 small studies suggesting that physiotherapy after TKR gives functional benefit at 3–4 months, SMD 0.37 (95%CI 0.12, 0.62; p=0.004) but not at later follow up. As noted in a recent review in THR, quality of evidence was limited. Our feasibility study evaluated six weeks of group-based activity-orientated rehabilitation in 46 TKR patients. The programme was well-received and attendance good. A fully-powered RCT is underway. We identified two ongoing studies targeting patients at risk of, or with, poor recovery. Conclusion. The evidence-base for comprehensive rehabilitation in THR and TKR is growing. Pre-surgical interventions may be effective but, in isolation, not acceptable to many patients. Ongoing definitive trials in TKR physiotherapy will guide future care. Well-designed trials of physiotherapy after THR and occupational therapy are needed. Ultimately, rehabilitation interventions throughout THR and TKR pathways may provide optimal care but this will need appropriate evaluation

Background: While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold:. 1) to examine the reporting of outcome measures in orthopaedic trials,. 2) to determine the feasibility of blinding in published orthopaedic trials and. 3) to examine the association between the magnitude of treatment differences and methodological safeguards such as blinding. Specifically, we focused on an association between blinding of outcome assessment and the size of the reported treatment effect; in other words: does blinding of outcome assessors matter?. Methods: We reviewed 32 identified RCTs published in the Journal of Bone and Joint Surgery (American Volume), in 2003 and 2004 for the appropriate use of outcome measures. These RCTs represented 3.4% (32/938) of all studies published during that time period. All RCTs were reviewed by two of us for:. 1) the outcome measures used and. 2) the use of a methodological safeguard: blinding. We calculated the magnitude of treatment effect of blinded compared to un-blinded outcome assessors. Results: The methodological validation and clinical usefulness of the clinician-based, patient-based, and generic outcome instruments varied. Ten of the 32 RCTs (31%) used a modified outcome instrument. Of these 10 trials, 4 (40%) failed to describe how the outcome instrument was modified. Nine (90%) of the 10 articles did not describe how their modified instrument was validated and retested. Sixteen (50%) of the 32 RCTs did not report blinding of outcome assessors where blinding would have been possible. Among those studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects (standardized mean difference 0.76 versus 0.25, p=0.01). Similarly, in those studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects (Odds ratio 0.13 versus 0.42, unblinded versus blinded, p< 0.001). The ratio of odds ratios (unblinded to blinded) was 0.31 suggesting that unblinded outcomes assessment was associated with an exaggeration of the benefit of a treatment’s effectiveness in our cohort of studies. Conclusion: Reported outcomes in RCTs are often modified and rarely validated. Half of the RCTs did not blind outcome assessors even though blinding of outcome assessors would have been feasible in each case. Treatment effects may be exaggerated if outcome assessors are unblinded. Emphasis should be placed on detailed reporting of outcome measures to facilitate generalization. Outcome assessors should be blinded where possible to prevent bias

Purpose: The CONSORT statement for the reporting of randomized controlled trials (RCTs) has limitations in its applicability to non-pharmacological trials. In response, the CLEAR NPT, a checklist that provides guidelines for the reporting of RCTs in surgery, has been developed. We aimed to. apply the CLEAR NPT to orthopaedic RCTs across multiple journals from 2004–2005, and. survey authors when items in the CLEAR NPT were not reported to determine if they were actually conducted. We hypothesized that “lack of reporting” did not necessarily correlate with “not being conducted”. Method: We searched for relevant orthopaedic RCTs across eight journals (four Orthopaedic, four General Medicine) in the period from January 2004 through December 2005. We applied the CLEAR NPT to all eligible studies. We contacted authors to determine what methodological safeguards were actually used, especially when details remained unclear from the publication. Results: We included eighty-seven RCTs from eightyfive scientific reports. In assessing the RCTs with the CLEAR NPT, seventy-three (84%) studies had unclear reporting of allocation concealment. Only seventeen (20%) studies made mention of operator skill or experience. Participant, ward staff, rehabilitation staff, clinical outcome assessor and non-clinical outcome assessor blinding were found to be unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%) and thirty-three (38%) studies respectively. Authors from forty-three RCTs responded to our survey. In direct contact, authors reported adequate allocation concealment 41% (95% CI = 25–58%) of the time when this was unclear from the RCT report. 70% of authors acknowledged that they had set objective measures such as minimum case criteria and/or comparison to good clinical outcomes. Authors specified that they had blinded relevant groups 28–40% of the time, despite unclear reporting in the publications. Conclusion: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias reducing safeguards not reported in an RCT did not occur. Our study reinforces the need for a tool like the CLEAR NPT to assess the methodology of surgical trials

Background: The recognised risk of post-operative venous thromboembolism (VTE), presenting as deep vein thrombosis (DVT) and/or pulmonary embolism (PE), after elective total hip and knee arthroplasty (THA and TKA) has always made the selection of suitable thromboprophylaxis treatment a clinical priority for orthopaedic surgeons. Over recent years there has been the emergence of new oral direct Factor Xa (FXa) inhibiting anticoagulants, which may replace the widely used low-molecular-weight heparins (LMWHs). Methods: A systematic review of published English-language literature (completed in July 2009) and surgical type meta-analyses were conducted to compare the efficacy (risk of any DVT, PE and all-cause mortality) and safety (risk of major bleeding requiring clinical intervention) of oral direct FXa inhibiting anticoagulants with LMWHs in THA and TKA. Results: Five eligible THA randomised-controlled trials (RCTs) with total of 9286 patients and three eligible TKA RCTs with 6917 patients were identified. The Der-Simonian-Laird random effects model was employed for each meta-analysis and heterogeneity between trials was explored statistically using the Mantel-Haenszel χ. 2. test. The efficacy meta-analysis of THA RCTs revealed an odds ratio (OR) 0.46 (95% confidence interval (c.i.) 0.23, 0.92), which was significantly (P = 0.03) in favour of the oral FXa inhibitors but there was sizable heterogeneity amongst trials (P = 0.0002). Although the safety meta-analysis of THA RCTs showed an increase incidence of major bleeding with the use of oral FXa inhibitors, OR 1.71 (95% c.i. 0.67, 4.39), this risk was not statistically significant (P = 0.26) with little heterogeneity between trials (P = 0.44). The efficacy meta-analysis of TKA RCTs demonstrated an efficacy OR 0.56 (95% c.i. 0.42, 0.73), in favour of the oral FXa inhibitors (P = 0.0001) with no significant heterogeneity (P = 0.21). The safety meta-analysis of TKA RCTs showed an increased occurrence of major bleeding with oral FXa inhibitors, OR 1.79 (95% c.i. 0.83, 3.87), but this was not statistically significant (P = 0.14) and heterogeneity between trials was low (P = 0.54). Conclusions: This review demonstrated an overall better efficacy for oral FXa inhibitors compared with LMWHs in thromboprophylaxis for both THA and TKA. Although it also revealed that oral FXa inhibitors were statistically as safe as LMWHs, there was clinically higher incidence of major bleeding with their use in both THA and TKA. These safety results coupled with the fact that currently no specific antidote exists, highlights the urgent need for further research and large RCTs to prove the clinical safety of all new oral direct FXa inhibiting anticoagulants

Purpose: The CLEAR NPT checklist provides guidelines for the reporting of non-pharmacological randomized controlled trials (RCTs). We aimed to. apply the CLEAR NPT to orthopaedic RCTs and. survey authors when items in the CLEAR NPT were not reported, to determine if they were actually conducted. Methods: We searched for orthopaedic RCTs across eight journals in the period from January 2004 through December 2005. We applied the CLEAR NPT to all eligible studies, and then contacted authors to determine what methodological safeguards were actually used. Results: We included eighty-seven RCTs from eighty-five scientific reports. In assessing the RCTs with the CLEAR NPT, seventy-three (84%) studies had unclear reporting of allocation concealment. Only seventeen (20%) studies made mention of operator skill or experience. Participant, ward staff, rehabilitation staff, clinical outcome assessor and non-clinical outcome assessor blinding were found to be unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%) and thirty-three (38%) studies respectively. Authors from forty-three RCTs responded to our survey. In direct contact, authors reported adequate allocation concealment 41% (95% CI = 25–58%) of the time when this was unclear from the RCT report. 70% of authors acknowledged that they had set objective measures such as minimum case criteria and/or comparison to good clinical outcomes. Authors specified that they had blinded relevant groups 28–40% of the time, despite unclear reporting in the publications. Conclusions: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias reducing safeguards not reported in an RCT did not occur

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

Aims. There is inconsistent evidence on whether prior spinal fusion surgery adversely impacts outcomes following total hip arthroplasty (THA). We conducted a systematic review and meta-analysis to assess the association between pre-existing spinal fusion surgery and the rate of complications following primary THA. Methods. We searched MEDLINE, Embase, Web of Science, and Cochrane Library up to October 2019 for randomized controlled trials (RCTs) and observational studies comparing outcomes of dislocation, revision, or reasons for revision in patients following primary THA with or without pre-existing spinal fusion surgery. Furthermore, we compared short (two or less levels) or long (three or more levels) spinal fusions to no fusion. Summary measures of association were relative risks (RRs) (with 95% confidence intervals (CIs)). Results. We identified ten articles corresponding to nine unique observational studies comprising of 1,992,366 primary THAs. No RCTs were identified. There were 32,945 cases of spinal fusion and 1,752,362 non-cases. Comparing prior spinal fusion versus no spinal fusion in primary THA, RRs (95% CI) for dislocation was 2.23 (1.81 to 2.74; seven studies), revision 2.14 (1.63 to 2.83; five studies), periprosthetic joint infection 1.71 (1.53 to 1.92; four studies), periprosthetic fracture 1.52 (1.28 to 1.81; three studies), aseptic loosening 1.76 (1.54 to 2.01; three studies), and any complications 2.82 (1.37 to 5.80; three studies) were identified. Both short and long spinal fusions, when compared with no fusion, were associated dislocation, revision, or reasons for revision. Conclusions. Patients with prior spinal fusion are at risk of adverse events following primary THA. Measures that reduce the risk of these complications should be considered in this high-risk population when undergoing primary THA. These patients should also be counselled appropriately around their risks of undergoing THA. Cite this article: Bone Joint J 2020;102-B(6):664–670

Background. Effectiveness of computer-assisted joint replacement (CA-TJR) compared to conventional TJR has been evaluated by a large body of literature. Systematic reviews provide a powerful, widely accepted, evidence-based approach to synthesize the evidence and derive conclusions, yet the strength of these conclusions is dependent on the quality of the review. Multiple systematic reviews compared CA-TJR and conventional TJR with conflicting results. We aimed to assess the quality of these reviews. Methods. We searched MEDLINE, EMBASE, the Cochrane, and Epistemonikos to identify SRs published through May 2017. Full-text articles that met inclusion criteria were retrieved and assessed independently by two reviewers. Evidence was qualitatively synthesized and summarized. Outcome measures were categorized into functional, radiological, and patient safety related. The corrected covered area (CCA) was calculated to assess the degree of overlap between SRs in analyzing the same primary studies. The AMSTAR 2, a valid and reliable tool, was applied to rate the confidence in the results of the SRs (Shea et al., 2017). AMSTAR-2 has 16 domains, of which 7 are critical (e.g., justification for excluding individual studies) and 9 are non-critical (e.g., not reporting conflict of interest for individual studies). Reviews are rated as high (no critical or non-critical flaws), moderate (only non-critical flaws), low (1 critical flaw) and critically low (more than one critical flaw). Disagreement between the 2 reviewers was resolved by discussion with the senior author to achieve consensus. We reported the quality ratings of these studies and the frequency of critical and non-critical flaws. Results. Of 384 citations originally identified, 37 systematic reviews were included. Meta-analyses that addressed TKA showed discrepancy on functional (e.g. KSS), radiological (mechanical axis malalignment), and patient safety (e.g. adverse events) outcomes. Meta-analyses that addressed THA showed more consistent results. Moderate overlap was observed among TKA SRs (CCA=7%) and very high overlap among THA SRs (CCA=26%). Based on the AMSTAR 2 tool, 35 studies were rated critically low and two studies were rated low. Low rating was due to failure in: developing a review protocol (94.6%); using a comprehensive search strategy (56.8%), providing a list of excluded studies (89%); accounting for risk of bias in the primary RCTs (44%), accounting for the risk of bias of the primary studies when discussing the results (70%), performing appropriate statistical methods (53% for RCTs and 88% for non-RCTs), and adequately investigating publication bias (53%). Conclusions. Given the very low confidence in the results of the SRs comparing CA to conventional total joint arthroplasty, clinicians should interpret the results of these SRs with caution. High methodological quality SRs are needed to inform evidence-based clinical practice

Aims. Dupuytren’s contracture is a benign, myoproliferative condition affecting the palmar fascia that results in progressive contractures of the fingers. Despite increased knowledge of the cellular and connective tissue changes involved, neither a cure nor an optimum form of treatment exists. The aim of this systematic review was to summarize the best available evidence on the management of this condition. Materials and Methods. A comprehensive database search for randomized controlled trials (RCTs) was performed until August 2017. We studied RCTs comparing open fasciectomy with percutaneous needle aponeurotomy (PNA), collagenase clostridium histolyticum (CCH) with placebo, and CCH with PNA, in addition to adjuvant treatments aiming to improve the outcome of open fasciectomy. A total of 20 studies, involving 1584 patients, were included. Results. PNA tended to provide higher patient satisfaction with fewer adverse events, but had a higher rate of recurrence compared with limited fasciectomy. Although efficacious, treatment with CCH had notable recurrence rates and a high rate of transient adverse events. Recent comparative studies have shown no difference in clinical outcome between patients treated with PNA and those treated with CCH. Conclusion. Currently there remains limited evidence to guide the management of patients with Dupuytren’s contracture. Cite this article: Bone Joint J 2018;100-B:1138–45

Aims. The aim of this study was to determine how the short- and medium- to long-term outcome measures after total disc replacement (TDR) compare with those of anterior cervical discectomy and fusion (ACDF), using a systematic review and meta-analysis. Patients and Methods. Databases including Medline, Embase, and Scopus were searched. Inclusion criteria involved prospective randomized control trials (RCTs) reporting the surgical treatment of patients with symptomatic degenerative cervical disc disease. Two independent investigators extracted the data. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. The primary outcome measures were overall and neurological success, and these were included in the meta-analysis. Standardized patient-reported outcomes, including the incidence of further surgery and adjacent segment disease, were summarized and discussed. Results. A total of 22 papers published from 14 RCTs were included, representing 3160 patients with follow-up of up to ten years. Meta-analysis indicated that TDR is superior to ACDF at two years and between four and seven years. In the short-term, patients who underwent TDR had better patient-reported outcomes than those who underwent ACDF, but at two years this was typically not significant. Results between four and seven years showed significant differences in Neck Disability Index (NDI), 36-Item Short-Form Health Survey (SF-36) physical component scores, dysphagia, and satisfaction, all favouring TDR. Most trials found significantly less adjacent segment disease after TDR at both two years (short-term) and between four and seven years (medium- to long-term). Conclusion. TDR is as effective as ACDF and superior for some outcomes. Disc replacement reduces the risk of adjacent segment disease. Continued uncertainty remains about degeneration of the prosthesis. Long-term surveillance of patients who undergo TDR may allow its routine use. Cite this article: Bone Joint J 2018;100-B:991–1001

Background: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required in the development or improvement of medical procedures and devices. However, neither uniform definitions nor established classifications about the reporting of complications exist. So complication reporting, even in orthopaedic trials is still up to the surgeons perception and understanding. The goal of this systematic review was to check whether essential data are consistently provided by the authors in the assessment of incidence, severity and characteristics of complications related to orthopaedic interventions in randomized controlled trials. Methods: Five major, peer-reviewed orthopaedic journals were screened for published randomized controlled trials (RCTs) between January 2006 and July 2007. All relevant papers were obtained, anonymized and evaluated by two external reviewers. A checklist consisting of three main parts: definition, evaluation and reporting was developed and applied for the assessment of complication reporting in RCTs. The results were stratified for the main area of the trial. Results: One hundred and twelve RCTs meeting our inclusion criteria were identified. The majority of RCTs (n = 73) reported on surgical treatment methods, with most of the trials focussing on arthroplasty (38%); surgical fracture treatment and other surgical interventions accounted for 13% each. Although complications were included as trial outcomes in two thirds of the studies, clear definitions of anticipated complications were provided at least partly in only two trials of fracture treatment and six other trials. It remained unclear whether authors considered the specific events “death”, “mal-union”, “impaired function” and “re-operation” as complications; “impaired function” was not considered as a complication in 93% of the trials and “re-operation” events were considered in only 50% of the trials dealing with surgical fracture treatments. In 83% of RCTs, the identity of the person or group assessing the complications was unknown and in a further 8%, this process was implemented by the treating surgeon. This review did not identify any trial involving a Data Safety Review Board for assessment and classification of complications. Conclusions: Due to the lack of homogeneity among the published trials, improvement in the reporting of complications is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and most importantly, clinical investigators

Introduction and Aims: Randomised controlled trials (RCTs) are frequently presented as the best design for studies of treatment effect because they minimise bias from unknown confounders. But, very few have been performed in orthopaedic and trauma surgery in comparison to other areas of medicine. This study investigated the perceived obstacles to performing RCTs, in order to identify areas where novel aspects of study design may facilitate randomisation in orthopaedic research. Method: A qualitative study was performed using a deliberate maximum variation sample of 24 orthopaedic surgeons from four countries, involved in all aspects of practice, teaching, research, research funding, ethical approval and publication. A semi-structured interview was used to explore surgeons’ perceptions of obstacles to performing RCTs. A computer-assisted framework approach was used to analyse transcripts of these interviews, and to identify consistent themes and connections between them. Results: Thirty-four discrete obstacles to performing RCTs in trauma and orthopaedic surgery were identified and classified. Many of these fell into six main themes:. A non-evaluative culture;. Misunderstanding of the scientific basis of trial design;. Lack of individual equipoise;. The complexity of the relationship between patient and surgeon;. Inadequate measures of outcome;. Practical problems associated with long follow-up, clinical work load and lack of funding. Conclusion: A complex set of perceived problems were identified. None of these problems is insurmountable. The performance of RCTs would be encouraged by development of a more evaluative culture, collaboration between surgeons and epidemiologists, and greater resources for, and commitment to, clinical research. Novel study designs to address lack of individual equipoise are possible and offer the prospect of much greater use of randomisation

Introduction: Randomized Controlled Trials (RCT) are the golden standard in nowadays evidence based outcome assessment. Nevertheless, RCTs in surgery are associated with several concerns. The major concern focuses on ethical issues when randomization is done. Method: We conducted an indebt analysis on advantages and disadvantages of three types of data acquisition (Case Control Study (CCS), RCT, and Registries) where scientific impact, ability to assess changes over time, cost efficiency, time consumption, ability to provide bench marks and other variables are compared. Results: RCTs are best regarding the scientific impact. Registers are superior in detecting changes over time (post market surveillance, early warning system), cost efficiency, time consumption, ability to provide benchmarks, local/national/international comparability and ability to let private practitioners participate. CCSs are of minor value in respect to all the assessed variables. Conclusion: In Surgery, registries are an excellent alternative to RCTs if a great majority of the treating physicians (in respect to a therapy) participate and if all the treated patients (per physician) are included. The register increases its scientific impact if alternative therapies are included (control). In this case, the scientific impact of a register is getting nearly equivalent to RCTs. Take home message: If ethical aspects allow an RCT, than the RCT is the study set up of choice when a new technique/implant has to be introduced in the market. Once the implant has proved its evidence, the following post market surveillance should be accompanied by registries (introduction of an implant in each country). If an RCT is not indicated (ethical or other contra indications), than registries should be used to prove evidence for an indicated therapy. CCSs are not recommended

Blood management protocols attempt to reduce blood loss by strategies including autologous blood donation, red cell salvage, normovolaemic haemodilution and haemostatic agents such as tranexamic acid (TXA). TXA usage in particular has become increasingly commonplace with numerous studies demonstrating a significant reduction in peri-operative blood loss and proportion of patients requiring transfusion, without increasing the risk of venous thromboembolism. Tourniquet usage has now become ubiquitous in TKA operations with reported benefits of improved visualization, shorter operative time and decreased intra-operative bleeding. However, its use is not without considerable complications including wounding dehiscence, increased venous thromboembolism, superficial wound infection and skin blistering. It is therefore imperative that we review tourniquet usage in light of ever evolving blood management strategies. The aim of this study was to evaluate the effect of stopping tourniquet usage in primary TKRs, performed by an experienced surgeon, in light of new blood reduction measures, such as a TXA. A retrospective analysis identified a total of 31 patients who underwent primary TKR without the use of a tourniquet from January 2018 to March 2019. This was compared to an earlier group of patients from the same surgeon undergoing TKR with the use of a tourniquet; dating from July 2016 to November 2017. All surgeries were performed within the same hospital (CXH). Peri-operative factors and outcome measures were collected for analysis. There was no significant difference in post-operative haemoglobin drop (Tourniquet, 23.1 g/L; No Tourniquet, 24.4 g/: p=0.604) and fall in haematocrit (Tourniquet, 0.082; No Tourniquet, 0.087: p=0.604). Allogenic blood transfusion rates were the same in both groups at 12.9% (2 patients) and blood loss was not found to be significantly different (Tourniquet, 1067ml; No tourniquet, 1058mls). No significant difference was found in operative time (Tourniquet, 103 minutes; No Tourniquet, 111.7 minutes: p=0.152) or length of stay (Tourniquet, 5.5 days; No Tourniquet, 5.2 days: p=0.516). Tranexamic acid usage was not found to be significant (p=1.000). ROM of motion and analgesia requirement was significantly better in the no tourniquet group on one post-operative day out of five analysed (p=0.025, p=00.011). No post-operative thromboembolic events were reported in either group. There was no significant difference in readmission rates (p=0.492) or complications (p=0.238). The increase in minor complications and potential increased VTE risk with tourniquet usage must be balanced against an improved visual field and reduced blood loss in TKR patients. Our study found no difference in post-operative blood loss and transfusion rates between tourniquet and no tourniquet groups. With ever evolving and improving blood loss management strategies, including the use of TXA, the application of tourniquet may not be needed. Further prospective RCTs are needed to assess the impact of tourniquet usage in light of this

A commonly misunderstood principle in medical literature is statistical significance. Often, statistically non-significant or negative results are thought to be evidence for equivalence; mistakenly validating treatment modalities and putting patients at risk. This study examines the prevalence of misinterpretation of negative results of superiority trials in orthopaedic literature and outlines the need for a non-inferiority or equivalence research design. Four orthopaedic journals – Journal of Paediatric Orthopaedics A, Journal of Bone and Joint Surgery American Volume, Journal of Arthroplasty and Journal of Shoulder and Elbow Surgery – were hand searched to identify all randomised control trials (RCTs) published within the time periods 2002–2003, 2007–2008 and 2012–2013. The identified RCTs were read and classified by study methodology, results obtained, and interpretation of results. A total of 237 RCTs were identified. When analysing the primary outcomes, 117 (49.4%) studies yielded negative results and 120 (50.8%) yielded positive results. Out of the 237 articles, 231 (97.5%) used superiority methodology and 6 (2.5%) used non-inferiority or equivalence methodology. Of the 231 studies that used superiority methodology, 115 (49.8%) obtained negative results; and 45 (39.1%) of those misinterpreted the negative results for equivalence. While no statistical differences were seen, there was an upward trend in utilising non-inferiority and equivalence methodologies over time. Given the frequency of misinterpreted negative results, there is an evident need for a more appropriate research methodology that shows equivalence of treatment methods. A non-inferiority or equivalence study design can address orthopaedic clinical dilemmas more suitably when trying to show one treatment is no worse or is equal to another treatment. Regarding orthopaedic treatment modalities as equivalent when studies show negative statistical results can be detrimental to patients and their clinical outcomes. A non-inferiority methodology can be used to accurately depict no difference between treatment methods rather than attempting to show one treatment method as superior

Aims. Our aim was to prepare a systematic review and meta-analysis to compare the outcomes of cemented and cementless hemiarthroplasty of the hip, in elderly patients with a fracture of the femoral neck, to investigate the mortality, complications, length of stay in hospital, blood loss, operating time and functional results. Materials and Methods. A systematic review and meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines on randomised controlled trials (RCTs), studying current generation designs of stem only. The synthesis of results was done of pooled data, with a fixed effects or random effects model, based on heterogeneity. Results. A total of five RCTs including 950 patients (950 hips) were included. Cementless stems were found to be associated with more complications compared with cemented stems (odds ratio (OR) 1.61, 95% confidence interval (CI) 1.12 to 2.31, p = 0.01), especially implant-related complications (OR 3.15, 95% CI 1.55 to 6.41, p = 0.002). The operating time was shorter for cementless stems (weighted mean difference -9.96 mins, 95%CI -12.93 to -6.98, p < 0.001). The data on functional outcomes could not be pooled. There was no statistically significant difference for any other outcome between the two methods of fixation. Conclusion. In hemiarthroplasty of the hip using current generation stems, cemented stems result in fewer implant-related complications and similar mortality compared with cementless stems. Cite this article: Bone Joint J 2017;99-B:421–31

Background. To conduct a systematic review and network meta-analysis of RCTs with the aims of comparing relevant clinical outcomes (i.e. VAS, WOMAC total and sub-score score, Lequesne Algofunctional index, joint space width change and adverse events) between diacerein, glucosamine and placebo. Methods. Medline and Scopus databases were searched from inception to August 29th, 2014, using PubMed and Scopus search engines and included RCTs or quasi-experimental designs comparing clinical outcomes between treatments. Data were extracted from original studies. A network meta-analysis was performed by applying weight regression for continuous outcomes and a mixed-effect Poisson regression for dichotomous outcomes. Results. Thirty-one of 505 identified studies were eligible. Compared to placebo, glucosamine showed significant improvement with unstandardized mean differences (UMD) in total Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), pain WOMAC, function WOMAC, and Lequesne score of −2.49 (95% confidence interval [CI], −4.14, −0.83), −0.75 (95% CI, −1.18, −0.32), −4.78 (95% CI, −5.96, −3.59) and −1.03 (95% CI, −1.34, −0.72), respectively. Diacerein clinically improves visual analog scores, function WOMAC, and stiffness WOMAC with UMD values of −2.23 (95% CI, −2.82, −1.64), −6.64 (95% CI, −10.50, −2.78) and −0.68 (95% CI, −1.20, −0.16) when compared to placebo. Conclusions. The network meta-analysis suggests that diacerein and glucosamine are equally efficacious for symptom relief in knee OA, but that the former has more side effects

Persistent post-surgical pain affects 10%-80% of individuals after common operations, and is more common among patients with psychological factors such as depression, anxiety, or catastrophising. We conducted a systematic review and meta-analysis of randomised, controlled trials to evaluate the efficacy of perioperative psychotherapy for persistent postsurgical pain and physical impairment. We searched Medline, PsycINFO, CINAHL, and the Cochrane Central Registry of Controlled Trials to identify relevant RCTs, in any language, from inception of each database to September 1, 2016. Paired independent reviewers identified studies, extracted data, and assessed risk of bias. We pooled treatment effects of perioperative psychotherapy on similar outcomes across eligible trials, focusing on intention-to-treat analysis. We used random effects models to perform all meta-analyses. The Grading of Recommendations, Assessment, Development and Evaluation system was used to assess the quality of evidence. Our search found 15 trials (2220 patients) that were eligible for review. For both persistent post-surgical pain and physical impairment, perioperative education was ineffective, while active psychotherapy suggested a benefit (test of interaction P=0.01 for both outcomes). Moderate quality evidence showed that active perioperative psychotherapy (cognitive-behaviour therapy, relaxation therapy, or both) significantly reduced persistent post-surgical pain [weighted mean difference (WMD) −1.06 cm on a 10 cm visual analogue scale for pain, 95% confidence interval (CI) −1.56 to −0.55 cm, risk difference (RD) for achieving no more than mild pain (3 cm or less) 14%, 95% CI 8–21%] and physical impairment [WMD −9.87% on the 0–100% Oswestry Disability Index, 95% CI −13.42 to −6.32%, RD for achieving no more than mild disability (20% or less) 21%, 95% CI 13–29%]. Perioperative cognitive behavioural therapy and relaxation therapy are effective for reducing persistent pain and physical impairment after surgery. High quality evidence shows no significant effects of perioperative education or psychological support on persistent post-surgical pain or physical impairment compared with usual care. Future studies should explore targeted psychotherapy for surgical patients at higher risk for poor outcome

Aims. The aims of this study were to establish the incidence of acute Achilles tendon rupture (AATR) in a North American population, to select demographic subgroups and to examine trends in the management of this injury in the province of Ontario, Canada. Patients and Methods. Patients ≥ 18 years of age who presented with an AATR to an emergency department in Ontario, Canada between 1 January 2003 and 31 December 2013 were identified using administrative databases. The overall and annual incidence density rate (IDR) of AATR were calculated for all demographic subgroups. The annual rate of surgical repair was also calculated and compared between demographic subgroups. Results. A total of 27 607 patients (median age, 44 years; interquartile range 26 to 62; 66.5% male) sustained an AATR. The annual IDR increased from 18.0 to 29.3 per 100 000 person-years between 2003 and 2013. The mean IDR was highest among men between the ages of 40 and 49 years (46.0/100 000 person-years). The annual rate of surgical repair dropped from 20.1 in 2003 to 9.2 per 100 AATRs in 2013. There was a noticeable decline after 2009. Conclusion. The incidence of AATR is increasing in Ontario, while the annual rate of surgical repair is decreasing. A sharp decline in the rate of surgical repair was noted after 2009. This coincided with the publication of several high-quality RCTs which showed similar outcomes for the ‘functional’ non-operative management and surgical repair. Cite this article: Bone Joint J 2017;99-B:78–86

Ten RCTs published between 2000 and 2013 support treating distal radius buckle fractures and other low-risk distal radius fractures with a removable splint and with no orthopaedic follow-up. Application of this evidence has been shown to be variable and suboptimal resulting in unnecessary costs to a strained healthcare system. The Canadian evidence on this topic has been generated by subspecialist physicians working in paediatric hospitals. It is unclear what factors affect the dissemination of this information. We investigated the association of hospital type and physician type with the application of best-evidence treatment for low-risk distal radius fractures in children with the goal of improving our understanding of evidence diffusion in Ontario for this common injury. We performed a retrospective population-based cohort study using linked health care administrative data. We identified all children aged 2–14 treated in Ontario emergency departments from 2003–2015 with distal radius fractures with no reduction and no operation within a six week period. We excluded refractures and children with comorbidities. We evaluated the followup received – orthopaedic, general practitioner, or none. We examined the data for trends over time. Multivariable log binomial regression was used to quantify associations between hospital and physician type and best-evidence treatment. We adjusted for patient-related variables including age, sex, rural or urban location, and socioeconomic status. 70,801 fractures were analyzed. Best-evidence treatment was more likely to occur in a small (RR 1.86, 95%CI 1.72–2.01), paediatric (RR 1.16, 95%CI 1.07–1.26), or community (RR 1.13, 95%CI 1.06–1.20) hospital compared with treatment in a teaching hospital. Best-evidence treatment was more likely if initial management was by a paediatrician with additional emergency medicine training (RR 1.73, 95%CI 1.56–1.92) or paediatrician (RR 1.22, 95%CI 1.11–1.34). Paediatric and teaching hospitals have improved their use of best-evidence over time while other hospital types have stagnated or deteriorated. Paediatricians, paediatricians with additional emergency medicine training, and emergency medicine residency trained physicians have improved their use of best-evidence over time, while other physician types have stagnated or deteriorated. Overall, only 20% of patients received best-evidence treatment and 70% had orthopaedic follow-up. Significant over-utilization of resources for low-risk distal radius fractures continues decades after the first randomized trials showed it to be unnecessary. Physician type and hospital rurality are most strongly associated with best-evidence treatment. Physician types involved in generating, presenting, and publishing best-evidence for this fracture type are successfully implementing it, while others have failed to change their practices. Rural hospitals are excellent resource stewards by necessity, but are deteriorating over time. Our results strongly indicate the need for targeted implementation strategies to explicitly apply clinical evidence in clinical practice Canada-wide, with the goal of providing more cost-effective care for common children's fractures

Background: Up to one third of adults have been estimated to have rotator cuff tendon (RCT) tears. Larger RCT tears are associated with poorer scores and function, and are more likely to re-rupture after surgical repairs, hence there is a need for earlier identification and treatment. The aim of this study was to identify biomarkers of RCT tear pathologies to aid accurate identification and monitoring of disease progression. FTIR provides unique biochemical fingerprints of tissue specimens. All molecules are excited to higher vibrational states at specific wavelengths, which can be used to identify the chemical composition of tissues. Methods: The chemical composition of 55 formalin-fixed RCTs was measured from patients aged between 20 and 89. RCT tears were classified according to size (Post et al.); 10 each of small, medium, large and massive and 5 partial tears. These torn RCTs were compared to 10 uninjured RCTs. A diamond attenuated total reflectance accessory was used with a FTIR spectrometer to collect spectra for each sample. The spectra were reduced and classified using standard multivariate analysis; principal component analysis (PCA), partial least square (PLS) and discriminant function analysis (DFA). Data pre-processing was applied to ensure accurate quantitative data analysis. Results: Hierarchical cluster (HCA) demonstrated that normal and torn tendons could be clearly differentiated, and RCT could also be distinguished by their tear size. Partial tears were clearly distinguishable from normal RCT. Using a genetic algorithm we identified the following spectral regions of importance which accounted for most of the features which discriminated between normal and torn tendons:. 1030–1200cm-1: carbohydrates, phospholipids,. 1300–1700, 3000–3350cm-1: collagen structural conformation and. 2800–3000 cm-1: lipids. Partial tears were distinguishable from other stages of tendon pathology based on a spectral region which correlated with collagen III. Conclusions: FTIR can clearly distinguish normal and different sized RCT tears. This prospective non-randomized study indicates that the onset of RCT tear pathology is mainly due to an alteration of the collagen structural arrangements, with associated changes in lipids and carbohydrates. Partial tears show early onset of chemical changes, particularly in collagen III, which could be used to identify earlier stages of disease. The approach described is rapid and has the potential to be used per-operatively to determine the quality of the tendon and extent of disease, thus guiding surgical repairs or allowing monitoring of disease progression or response to treatments

Aims. In approximately 20% of patients with ankle fractures, there is an concomitant injury to the syndesmosis which requires stabilisation, usually with one or more syndesmotic screws. The aim of this review is to evaluate whether removal of the syndesmotic screw is required in order for the patient to obtain optimal functional recovery. Materials and Methods. A literature search was conducted in Medline, Embase and the Cochrane Library for articles in which the syndesmotic screw was retained. Articles describing both removal and retaining of syndesmotic screws were included. Excluded were biomechanical studies, studies not providing patient related outcome measures, case reports, studies on skeletally immature patients and reviews. No restrictions regarding year of publication and language were applied. Results. A total of 329 studies were identified, of which nine were of interest, and another two articles were added after screening the references. In all, two randomised controlled trials (RCT) and nine case-control series were found. The two RCTs found no difference in functional outcome between routine removal and retaining the syndesmotic screw. All but one of the case-control series found equal or better outcomes when the syndesmotic screw was retained. However, all included studies had substantial methodological flaws. Conclusions. The currently available literature does not support routine elective removal of syndesmotic screws. However, the literature is of insufficient quality to be able to draw definitive conclusions. Secondary procedures incur a provider and institutional cost and expose the patient to the risk of complications. Therefore, in the absence of high quality evidence there appears to be little justification for routine removal of syndesmotic screws. Cite this article: Bone Joint J 2016;98-B:1497–1504

Objectives. The objective of this study was to perform a meta-analysis of all randomised controlled trials (RCTs) comparing surgical and non-surgical management of fractures of the proximal humerus, and to determine whether further analyses based on complexity of fracture, or the type of surgical intervention, produced disparate findings on patient outcomes. Methods. A systematic review of the literature was performed identifying all RCTs that compared surgical and non-surgical management of fractures of the proximal humerus. Meta-analysis of clinical outcomes was performed where possible. Subgroup analysis based on the type of fracture, and a sensitivity analysis based on the type of surgical intervention, were also performed. Results. Seven studies including 528 patients were included. The overall meta-analysis found that there was no difference in clinical outcomes. However, subgroup and sensitivity analyses found improved patient outcomes for more complex fractures managed surgically. Four-part fractures that underwent surgery had improved long-term health utility scores (mean difference, MD 95% CI 0.04 to 0.28; p = 0.007). They were also less likely to result in osteoarthritis, osteonecrosis and non/malunion (OR 7.38, 95% CI 1.97 to 27.60; p = 0.003). Another significant subgroup finding was that secondary surgery was more common for patients that underwent internal fixation compared with conservative management within the studies with predominantly three-part fractures (OR 0.15, 95% CI 0.04 to 0.63; p = 0.009). Conclusion. This meta-analysis has demonstrated that differences in the type of fracture and surgical treatment result in outcomes that are distinct from those generated from analysis of all types of fracture and surgical treatments grouped together. This has important implications for clinical decision making and should highlight the need for future trials to adopt more specific inclusion criteria. Cite this article: S. Sabharwal, N. K. Patel, D. Griffiths, T. Athanasiou, C. M. Gupte, P. Reilly. Trials based on specific fracture configuration and surgical procedures likely to be more relevant for decision making in the management of fractures of the proximal humerus: Findings of a meta-analysisBone Joint Res 2016;5:470–480. DOI: 10.1302/2046-3758.510.2000638

Purpose. Infections in orthopaedic surgery are costly, debilitating complications. The search for new treatments and prevention strategies has led to the use of antibiotic-filled calcium sulfate (CaS) as a bone void filler that is both safe and effective. The purpose of this study was to examine the available data on the efficacy of this technology. Methods. A literature search was performed for studies that evaluated the use of antibiotic-loaded CaS cement in orthopaedics published between inception of the databases to 2017. Selected studies included randomized controlled trials (RCTs) and observational studies published in the English language that met the following criteria: 1) patients underwent an orthopaedic procedure; 2) CaS cement with an antibiotic was used; and 3) at least one of our outcomes were mentioned. Outcomes included resolution of infection, complications related to treatment, subsequent surgeries, overall infection rate, fracture union rate, clinical outcomes, and wound complications. A total of 17 studies were included. Results. Ten studies examined the use of antibiotic-eluting CaS cement with surgical debridement to treat osteomyelitis and reported resolution rates ranging from 80–100%. Two studies examined CaS for prophylaxis of infection after open fracture, with subsequent infection rates ranging from 0–22%. Two studies examined infected non-unions with CaS used as an adjunct to surgery with an 87.5% infection clearance rate. Finally, three studies examined the use of local antibiotic release from CaS in the repair of infected TKAs or THAs, with success rates ranging from 52–93.3%. Conclusion. Initial results support the use of CaS with surgical debridement for osteomyelitis and infected non-unions. Results are mixed for CaS use in the prophylaxis of infection after open fractures and for PJIs, thereby necessitating further research. Overall the studies were small, retrospective, and lacked controls. Further research should focus on RCTs to minimize bias and investigate for non-inferiority. For any figures or tables, please contact authors directly

Objectives. Tranexamic acid (TXA) is an antifibrinolytic agent used as a blood-sparing technique in total knee arthroplasty (TKA), and is routinely administered by intravenous (IV) or intra-articular (IA) injection. Recently, a novel method of TXA administration, the combined IV and IA application of TXA, has been applied in TKA. However, the scientific evidence of combined administration of TXA in TKA is still meagre. This meta-analysis aimed to investigate the efficacy and safety of combined IV and IA TXA in patients undergoing TKA. Materials and Methods. A systematic search was carried out in PubMed, the Cochrane Clinical Trial Register (Issue12 2015), Embase, Web of Science and the Chinese Biomedical Database. Only randomised controlled trials (RCT) evaluating the efficacy and safety of combined use TXA in TKA were identified. Two authors independently identified the eligible studies, extracted data and assessed the methodological quality of included studies. Meta-analysis was conducted using Review Manager 5.3 software. Results. A total of ten RCTs (1143 patients) were included in this study. All the included studies were randomised and the quality of included studies still needed improvement. The results indicated that, compared with either placebo or the single-dose TXA (IV or IA) group, the combination of IV and IA TXA group had significantly less total blood loss, hidden blood loss, total drain output, a lower transfusion rate and a lower drop in haemoglobin level. There were no statistically significant differences in complications such as wound infection and deep vein thrombosis between the combination group and the placebo or single-dose TXA group. Conclusions. Compared with placebo or the single-dose TXA, the combined use of IV and IA TXA provided significantly better results with respect to all outcomes related to post-operative blood loss without increasing the risk of thromboembolic complications in TKA. Cite this article: Z. F. Yuan, H. Yin, W. P. Ma, D. L. Xing. The combined effect of administration of intravenous and topical tranexamic acid on blood loss and transfusion rate in total knee arthroplasty: combined tranexamic acid for TKA. Bone Joint Res 2016;5:353–361. DOI: 10.1302/2046-3758.58.BJR-2016-0001.R2

Three-dimensional (3D) printing has become more frequently used in surgical specialties in recent years. Orthopaedic surgery is particularly well-suited to 3D printing applications, and thus has seen a variety of uses for this technology. These uses include pre-operative planning, patient-specific instrumentation (PSI), and patient-specific implant production. As with any new technology, it is important to assess the clinical impact, if any, of three-dimensional printing. The purpose of this review was to answer the following questions: . What are the current clinical uses of 3D printing in orthopaedic surgery?. Does the use of 3D printing have an effect on peri-operative outcomes?. Four electronic databases (Embase, MEDLINE, PubMed, Web of Science) were searched for Articles discussing clinical applications of 3D printing in orthopaedics up to November 13, 2018. Titles, abstracts, and full texts were screened in duplicate and data was abstracted. Descriptive analysis was performed for all studies. A meta-analysis was performed among eligible studies to compare estimated blood loss (EBL), operative time, and fluoroscopy use between 3D printing cases and controls. Study quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) criteria for non-randomized studies and the Cochrane Risk of Bias Tool for randomized controlled trials (RCTs). This review was prospectively registered on PROSPERO (Registration ID: CRD42018099144). One-hundred and eight studies were included, published between 2012 and 2018. A total of 2328 patients were included in these studies, and 1558 patients were treated using 3D printing technology. The mean age of patients, where reported, was 47 years old (range 3 to 90). Three-dimensional printing was most commonly reported in trauma (N = 41) and oncology (N = 22). Pre-operative planning was the most common use of 3D printing (N = 63), followed by final implants (N = 32) and PSI (N = 22). Titanium was the most commonly used 3D printing material (16 studies, 27.1%). A wide range of costs were reported for 3D printing applications, ranging from “less than $10” to $20,000. The mean MINORS score for non-randomized studies was 8.3/16 for non-comparative studies (N = 78), and 17.7/24 for non-randomized comparative studies (N = 19). Among RCTs, the most commonly identified sources of bias were for performance and detection biases. Three-dimensional printing resulted in a statistically significant decrease in mean operative time (−15.6 mins, p < .00001), mean EBL (−35.9 mL, p<.00001), and mean fluoroscopy shots (−3.5 shots, p < .00001) in 3D printing patients compared to controls. The uses of 3D printing in orthopaedic surgery are growing rapidly, with its use being most common in trauma and oncology. Pre-operative planning is the most common use of 3D printing in orthopaedics. The use of 3D printing significantly reduces EBL, operative time, and fluoroscopy use compared to controls. Future research is needed to confirm and clarify the magnitude of these effects

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169–74

Background and Purpose. Non-specific chronic low back pain (NSCLBP) poses a significant disability and economic burden worldwide. Fear avoidance is suggested to contribute to its chronicity and reduced treatment effect. National guidelines recommend exercise as a component of multidisciplinary rehabilitation but its interaction with fear avoidance is ambiguous. This systematic review examined the effect of exercise-based interventions (EBIs) on fear avoidance NSCLBP. Methods and Results. RCTs comparing EBIs to usual care in adults with NSCLBP were included. A systematic search of CINAHL, Medline, EMBASE, Web of Science, Scopus and Cochrane Library (up to January 2019) revealed 10 eligible trials. Following risk of bias assessment, 6 studies were included for data extraction and narrative synthesis. EBIs were not found superior to usual care in reducing fear avoidance at any follow-up. There was evidence that reducing fear avoidance is probably not the mechanism through which EBIs affect pain and disability. In adherent patients, EBIs did not result in greater clinically relevant improvements in pain or disability than usual care, in the short- or intermediate-term. Conclusion. Addition of EBIs as part of multidisciplinary rehabilitation is not more beneficial than that of usual care in reducing fear avoidance in NSCLBP patients. However, the findings of this review are based on heterogenous studies presenting with methodological limitations. Further high-quality research is required to examine the review's findings and investigate current physiotherapy management of fear avoidance in NSCLBP. No conflicts of interest. No funding obtained

Introduction Zygapophysial joint pain can be treated by RF neurotomy of the medial branch of the dorsal primary rami of the adjacent spinal nerves. The provision of radiofrequency (RF) neurotomy for spinal joint pain has been highlighted as an emerging trend in Australia, Europe and North America. However, there is controversy regarding the efficacy of this procedure. RF neurotomy for spinal pain has been investigated in several experimental and observational studies but these have reported conflicting results. The purpose of this project was to provide a systematic review of the literature on RF neurotomy for the treatment of spinal pain of zygapophysial joint origin. Method Electronic database searches, screening of reference lists, hand searching and consultation with experts in the field was undertaken to identify relevant studies. Publications were selected based on predetermined inclusion criteria and the methodological quality of each was rated. Qualitative analysis was performed using the Cochrane Collaboration Back Review Group (CCBRG) levels of evidence (RCTs only) and those used by the National Health and Medical Research Council (NHMRC) (RCTs, observational studies, systematic reviews and guidelines). Results The search strategy identified 382 potential publications. Of these, 80 studies were selected for review, including 7 RCTs, 52 observational studies, 11 systematic reviews and 10 guidelines. There is conflicting (CCBRG) evidence regarding the efficacy of RF neurotomy for lumbar zygapophysial joint pain. The conclusions of systematic reviews and observational studies are conflicting regarding the efficacy of this procedure for the lumbar spine. In contrast, there is limited (CCBRG) evidence that RF neurotomy is efficacious for neck pain of zygapophysial joint origin in the short term. However, this was reported in one very small RCT which reported only one composite outcome. Discussion This systematic review found that there is no consistent evidence from either multiple (large) RCTs or systematic reviews that RF neurotomy is efficacious in the treatment of spinal joint pain RCTs need to be conducted with larger sample sizes, (patient) relevant outcomes and adequate assessment of side-effects, which can be serious

Background: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. Methods: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the four highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003–2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. Results: We found that only the Journal of Bone and Joint Surgery–American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p> 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC=0.80, 95%CI:0.60 to 0.90). Conclusions: Our findings suggest that readers should not assume that. 1) studies labelled as Level I have high reporting quality and. 2) Level I studies have better reporting quality than Level II studies. One should address methodological safeguards individually

Acute metatarsal fractures are a common extremity injury. While surgery may be recommended to reduce the risk of nonunion or symptomatic malunion, most fractures are treated with nonoperative management. However, there is significant variability between practitioners with no consensus among clinicians on the most effective nonoperative protocol, despite how common the form of treatment. This systematic review identified published conservative treatment modalities for acute metatarsal fractures and compares their non-union rate, chronic pain, and length of recovery, with the objective of identifying a best-practices algorithm. Searches of CINAHL, EMBASE, MEDLINE, and CENTRAL identified clinical studies, level IV or greater in LOE, addressing non-operative management strategies for metatarsal fractures. Two reviewers independently screened the titles, abstracts, and full texts, extracting data from eligible studies. Reported outcome measures and complications were descriptively analyzed. Studies were excluded if a rehabilitation program outlining length of immobilization, weight-bearing and/or strengthening approaches was not reported. A total of 12 studies (8 RCTs and 4 PCs), from the 2411 studies that were eligible for title screening, satisfied inclusion criteria. They comprised a total of 610 patients with acute metatarsal fractures, with a mean age of 40.2 years (range, 15 – 82). There were 6 studies that investigated avulsion fractures, 2 studies on true Jones fractures, and 4 studies with mixed fracture types. Studies assessed a variety of treatment modalities including: WB and NWB casts, elasticated support bandages, hard-sole shoes, plaster slippers, metatarsal shoe casts, and air cast boots. Most studies investigated the outcomes of NWB casts and elasticated support bandages. The NWB short leg cast had no reported non-unions, delayed-unions, or refractures for avulsion fractures. In true Jones fractures, there was an average non-union rate of 23.6% (range, 5.6 – 27.8%), delayed-union rate of 11.8% (range, 5.6 – 18.8%), and refracture rate of 3% (range, 0 – 5.6%). Overall, the average AOFAS score was 87.2 (range, 84 – 91.7) and the average VAS score was 83.7 (range, 75 – 93). The elasticated support bandage had an average non-union rate of 3.4% (range, 0 – 12%), and delayed-union rate of 3.8% for acute avulsion fractures, with no reported refractures. No included study arm investigated outcomes of elasticated support bandages for the true Jones fracture. The average AOFAS score for elasticated support bandages was 93.5 (range, 90 – 100). The average VAS score was 88.9 (range, 90 – 100). Most acute metatarsal fractures heal well, with good-to-excellent functional outcomes and moderate-to-high patient satisfaction. Conservative strategies for avulsion fractures are highly successful and based on this data the authors recommend patients undergo a schedule that involves 3 – 4 weeks in an elasticated support bandage, short leg cast, or equivalent, and WB thereafter as tolerated, with return-to-activity after clinical union. Despite poorer conservative outcomes for true Jones fractures, patients should undergo 8 weeks in a NWB short leg cast, followed by a walking cast or hard-sole shoe for an additional 4 – 6 weeks, or until clinical union. However, surgical consultation is recommended

This article is a systematic review of the published literature about the biomechanics, functional outcome and complications of intramedullary nailing of fractures of the distal radius. We searched the Medline and EMBASE databases and included all studies which reported the outcome of intramedullary (IM) nailing of fractures of the distal radius. Data about functional outcome, range of movement (ROM), strength and complications, were extracted. The studies included were appraised independently by both authors using a validated quality assessment scale for non-controlled studies and the CONSORT statement for randomised controlled trials (RCTs). The search strategy revealed 785 studies, of which 16 were included for full paper review. These included three biomechanical studies, eight case series and five randomised controlled trials (RCTs). . The biomechanical studies concluded that IM nails were at least as strong as locking plates. The clinical studies reported that IM nailing gave a comparable ROM, functional outcome and grip strength to other fixation techniques. . However, the mean complication rate of intramedullary nailing was 17.6% (0% to 50%). This is higher than the rates reported in contemporary studies for volar plating. It raises concerns about the role of intramedullary nailing, particularly when comparative studies have failed to show that it has any major advantage over other techniques. Further adequately powered RCTs comparing the technique to both volar plating and percutaneous wire fixation are needed. Cite this article: Bone Joint J 2015;97-B:1370–6

Purpose of the study and background. A 2011 Cochrane review concluded that spinal manipulative therapy (SMT) is no better than other interventions for reducing pain and improving function in chronic low back pain (CLBP). Using individual participant data (IPD) from trials has advantages, among others: a more precise estimate of the effect and the potential to identify moderators. Our objective was to assess the effect of SMT in adults with CLBP and to identify relevant moderators. Methods. All trials from the 2011 Cochrane review were included in this IPD. We updated the search (April 2016) IPD from eligible studies was requested. Primary outcomes were pain intensity (VAS/NRS) and back-specific function (RMDQ). Risk of bias was assessed. For the treatment effect, an one-stage approach (mixed model technique, intention-to-treat principle) was used; a second-stage approach was conducted as confirmation. For the moderator analyses, one-stage approach was conducted for 19 variables. Results. We obtained IPD from 21 RCTs (n= 4638). Most studies were pragmatic comparing the SMT effect to recommended therapies (e.g. exercise). Effects for SMT were slightly, but not clinically better compared to other therapies for primary outcomes. For the moderator analysis, 8 moderators showed a statistical significant effect at a specific time point (e.g. for SMT vs recommended therapy: age, both pain and function at 26 weeks). But for none of the moderators a consistent effect was identified across time points. Conclusion. Findings of the Cochrane review were confirmed. No clinically-relevant moderators were identified for SMT compared to other therapies for pain and function at any follow-up measure. No conflicts of interest. Sources of funding: European Chiropractic Research fund

Improved understanding of the biomechanics and biology of rotator cuff tendons (RCT) may help reduce high re-rupture rates following repairs, particularly amongst larger tears. This study aims to use novel methods for quantitatively determining differences in the mechanical and thermal properties of intact healthy RCTs compared to torn ‘diseased’ tendons. A common problem in the mechanical testing of small tendon samples is that stress risers at the clamp-tendon interface can obscure measurements. As the shoulder is subject to shear, tension and compression, we developed a novel solution using Dynamic Shear Analysis (DSA), a form of rheology which studies material deformation. As collagen is the main component of RCT, the structure and mechanical properties may be affected by collagen conformational changes. Both dermis and rat tail tendon with increased collagen cross-linking exhibit stronger mechanical properties. Thermal changes detected by differential scanning calorimetry (DSC) can help to quantify collagen structural differences in torn RCT, and has been previously used to study muscle, cartilage and vertebral discs. There were 79 tears (mean age 65.2 years), which were classified according to the size of the tear as small, medium, large and massive. Two separate 3mm-sized biopsy samples were taken and subjected to DSA using oscillatory deformation under compression. The storage modulus (G') was calculated and used as an indicator of mechanical integrity. 18 control tendon specimens were obtained from patients aged between 22-89 years (mean age 58.8 years) during shoulder hemiarthroplasties and stabilisations. Additionally 7 normal, 7 small and 7 massive frozen specimens were thermally characterized. 3 samples per patient were heated between 20-80oC in hermetically sealed vessels. Useful thermal parameters were measured such as the melting temperature (TM) which apparently represents breaking of the amide-amide bonds and protein chains mobility, the denaturation temperature (TD) which supposedly corresponds to proteins falling out of solution and the denaturation enthalpy (ΔH) which reflects the relative amount of triple helical structure. Healthy tendons had a significantly higher modulus than torn tendons, indicating that torn tendons are mechanically weaker than normal tendons (p = 0.032). Normal tendons had significantly higher mean shear modulus than tendons with small and massive tears (p<0.01). Overall there was a negative correlation between moduli and severity of tendon tear (r = −0.698, p=0.189). The moduli did not significantly correlate with age, sex, hand dominance, or length of preservation in formalin. Massive RCT tears had significantly higher TM and TD when compared to normal RCT (p < 0.05), unlike small RCT tears. No significant difference was detected between the denaturation enthalpy of the different RCT groups. This case control study has demonstrated that normal RCTs have a significantly higher modulus than torn tendons, indicating that torn tendons have less mechanical integrity. Our study further demonstrated a trend between increasing tear size and decreasing mechanical integrity. This study has also demonstrated differences in some of the thermal properties of normal and torn RCTs. These are likely due to collagen structural changes. A decrease in the denaturation temperature of torn tendons, suggests that the material is intrinsically less stable. Torn tendons with reduced storage modulus and collagen integrity may be less able to withstand mechanical loads following repair. This pilot study provides some preliminary insight into the mechanisms that may contribute to, or represent adaptations to high rates of failure of RCT repairs

Introduction. There has been a paradigm shift in orthopaedic research, it is now recognized that the extent to which interventions really make a difference to a patient's overall life is indicated by measuring one's general health status. The primary aim of this study was to report how the methodology of current evidence in hip fracture research can improve if studies included patients with cognitive impairment. Materials and methods. Using multiple databases inclusive from 1990 to May 2009, we performed a systematic review of all hip fracture observational cohorts and randomized studies (RCTs). Results. We compared the screening and outcome measures in 190 studies: 79 unique RCTs and 111 cohorts were included (kappa, 0.83; 95% CI: 0.79 − 0.87). In RCTs, 24 (30.4%) trials screened for co-morbidities, 19 (24.1%) trials screened for cognitive impairment, and only 14 (17.7%) trials included patients with dementia. In the cohort studies, 27 (24.3%) screened for co-morbidities, 47 (42.3%) screened for cognitive impairment, and only 33 (29.7%) included patients with dementia. In the 7 cohorts that used proxy responders to assess functional outcomes, only one measured health status and two measured utility. Discussion and Conclusion. Studies would be more relevant to surgeons and patients if researchers measured health status and utilized screening methods for dementia to promote better treatment strategies

Aims

Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research.

We aimed to quantify the sample sizes and magnitude of treatment effects in a review of orthopaedic randomised trials with statistically significant findings. We conducted a comprehensive search (PubMed, Cochrane) for all randomised controlled trials between 1/1/95 to 12/31/04. For continuous outcome measures (ie functional scores), we calculated effect sizes (mean difference/standard deviation). Dichotomous variables (ie infection, nonunion) were summarised as absolute risk differences and relative risk reductions (RRR). Effect sizes > 0.80 and RRRs> 50% were defined as large effects. Our search yielded 433 RCTs, of which 76 RCTs with statistically significant findings on 184 outcomes (122 continuous/62 dichotomous outcomes) met study eligibility criteria. The mean effect size across studies with continuous outcome variables was 1.7 (95% confidence interval: 1.43–1.97). Almost one in three results, despite being reported as statistically significant did meet the definition of a large effect size (ES< 0.80). For dichotomous outcomes, the mean risk difference was 30% (95%confidence interval:24%–36%) and the mean relative risk reduction was 61%

The principle function of the “short external rotator” muscle group is primarily as an abductor and extensor of the flexed hip and is better referred to as the “Quadriceps Coxa” (QC). The QC has a profound influenced on weight bearing rising and propulsive motions. The SPAIRE technique preserves Obturator Internus (OI) and Piriformis (P) resulting in improved stability of the hip and potentially improved recovery and function in patients undergoing hip arthroplasty. Short term outcomes of the first 42 consecutive SPAIRE cases are compared with 86 consecutive cases using the traditional posterior approach that immediately preceded introduction of the technique. The purpose was to document the learning curve and confirm the safety of introducing SPAIRE into routine clinical practice. The two groups were comparable and there was no statistically significant difference in length of stay, blood loss, intra-or post-operative complications nor radiological measurements relating to the femoral or acetabular components. Statistically significant differences were found for component usage (more uncemented acetabula for SPAIRE), length of operation (8 mins longer with SPAIRE); patient satisfaction was higher at 6 weeks and measured leg length discrepancy less in the SPAIRE group. SPAIRE has been used routinely for all routine arthroplasties for over two years. RCTs are ongoing to document the effect of SPAIRE on recovery, long term function and activity level. If the potential benefits are confirmed SPAIRE may become the default technique for hip arthroplasty operations through a posterior approach for elective and hip fracture cases

Background: We aimed to explore the incidence and risk of adverse events associated with manual therapies. Method: The main health electronic databases, plus those specific to allied medicine and manual therapy professions, were searched. Our inclusion criteria for relevant studies were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. We performed a meta-analysis using incident estimates of proportions and random effects models from relevant prospective cohort studies and randomised controlled trials (RCTs) published after 1997. Results: Eight prospective cohort studies and 31 manual therapy RCTs were identified and analysed. The incidence estimate of proportions of minor or moderate transient adverse events after manual therapy was ~41% (CI 95% 17–68%) in the cohort studies and 22% (CI 95% 11.1–36.2%) in the RCTs. The estimate for major adverse events was between 0.007 and 0.13%. No deaths or vascular accidents occurred in any studies. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham, passive or control interventions compared to manual therapy was similar, but compared to drug therapies greater (RR 0.05, CI 95% 0.01–0.20) and less when compared to general practitioner or usual care (RR 1.91, CI 95% 1.39–2.64). Conclusions: Our data indicate a very low risk of major adverse events with manual therapy, but around half manual therapy patients may experience minor to moderate adverse events after treatment. The relative risk of adverse events appears greater with drug therapy but less with usual medical care. Conflicts of Interest: D Carnes & T Mars. Source of Funding: National Council for Osteopathic Research

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

Cite this article: Bone Joint J 2023;105-B(7):719–722.

Aims

Hand trauma, consisting of injuries to both the hand and the wrist, are a common injury seen worldwide. The global age-standardized incidence of hand trauma exceeds 179 per 100,000. Hand trauma may require surgical management and therefore result in significant costs to both healthcare systems and society. Surgical site infections (SSIs) are common following all surgical interventions, and within hand surgery the risk of SSI is at least 5%. SSI following hand trauma surgery results in significant costs to healthcare systems with estimations of over £450 per patient. The World Health Organization (WHO) have produced international guidelines to help prevent SSIs. However, it is unclear what variability exists in the adherence to these guidelines within hand trauma. The aim is to assess compliance to the WHO global guidelines in prevention of SSI in hand trauma.

Aims

With up to 40% of patients having patellofemoral joint osteoarthritis (PFJ OA), the two arthroplasty options are to replace solely the patellofemoral joint via patellofemoral arthroplasty (PFA), or the entire knee via total knee arthroplasty (TKA). The aim of this study was to assess postoperative success of second-generation PFAs compared to TKAs for patients treated for PFJ OA using patient-reported outcome measures (PROMs) and domains deemed important by patients following a patient and public involvement meeting.

Purpose: Today, numerous functional outcome tools exist to assess the patient’s ability to carry out basic and instrumental activities of daily living. Furthermore, the increase in range of mobility measures reflect differences in rating scales, scores, administration and scoring options which make outcome results difficult to assess across trials. Because of the lack of consensus among investigators, we wanted to identify the citation patterns of the functional outcomes tools used by investigators in hip fracture RCTs. We believed that the lack of proper citation is an underlying factor in the diverse usage of outcome tools. Method: We extracted the citations of disability tools from 59 Level 1 hip fracture RCTs. Disability was defined using the WHO classification (ICF). We excluded measures assessing body structure. The text and reference lists of the identified articles were screened in order to compile relevant literature on the instrument used in the RCT. Disability tools which were cited in the references were also compared to original development articles. Results: Overall 68 different instruments were identified that measured disability in the hip fracture literature. According to ICF, 47 tools measured body function alone, 13 tools evaluated activity limitations and participation restriction and 8 were composite scoring systems. We found that 34.2% of the trials did not provide any citations to the tools assessing body function. In trials measuring activity and participation, 23.2% provided instrument citations. In trials using composite scoring systems, 19.4% of the trials provided instrument citations. All of the instrument citations when provided by the investigators were found to correspond to original development articles or trials. Conclusion: The appropriate choice of a functional outcome instrument is fundamental in order to ensure that the results that are obtained reflect the patient. However, if citations of the indices and scales themselves are lacking, trial methodology and results could be informative but not replicated. In the future, we recommend that rigor in quality reporting include proper instrument citations

Aims

Hip fractures are a major cause of morbidity and mortality, and malnutrition is a crucial determinant of these outcomes. This meta-analysis aims to determine whether oral nutritional supplementation (ONS) improves postoperative outcomes in older patients with a hip fracture.

Aims

Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set.

The June 2023 Shoulder & Elbow Roundup³⁶⁰ looks at: Proximal humerus fractures: what does the literature say now?; Infection risk of steroid injections and subsequent reverse shoulder arthroplasty; Surgical versus non-surgical management of humeral shaft fractures; Core outcome set needed for elbow arthroplasty; Minimally invasive approaches to locating radial nerve in the posterior humeral approach; Predictors of bone loss in anterior glenohumeral instability; Does the addition of motor control or strengthening exercises improve rotator cuff-related shoulder pain?; Terminology and diagnostic criteria used in patients with subacromial pain syndrome.

Aims

Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted.