Objectives. Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. Methods. The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1

We undertook a prospective randomised controlled trial to investigate the efficacy of autologous retransfusion drains in reducing the need for allogenic blood requirement after unilateral total knee replacement. We also monitored the incidence of post-operative complications. There were 86 patients in the control group, receiving standard care with a vacuum drain, and 92 who received an autologous drain and were retransfused postoperatively. Following serial haemoglobin measurements at 24, 48 and 72 hours, we found no difference in the need for allogenic blood between the two groups (control group 15.1%, retransfusion group 13% (p = 0.439)). The incidence of post-operative complications, such as wound infection, deep-vein thrombosis and chest infection, was also comparable between the groups. There were no adverse reactions associated with the retransfusion of autologous blood. Based on this study, the cost-effectiveness and continued use of autologous drains in total knee replacement should be questioned

We reviewed all 717 manuscripts published in the 1997 issues of the British and American volumes of the Journal of Bone and Joint Surgery and in Clinical Orthopaedics and Related Research, from which 33 randomised, controlled trials were identified. The results and sample sizes were used to calculate the statistical power of the study to distinguish small (0.2 of standard deviation), medium (0.5 of standard deviation), and large (0.8 of standard deviation) effect sizes. Of the 33 manuscripts analysed, only three studies (9%) described calculations of sample size. To perform post-hoc power assessments and estimations of deficiencies of sample size, the standard effect sizes of Cohen (small, medium and large) were calculated. Of the 25 studies which reported negative results, none had adequate power (β < 0.2) to detect a small effect size and 12 (48%) lacked the power necessary to detect a large effect size. Of the 25 studies which did not have an adequate size of sample to detect small differences, the average used was only 10% of the required number. Our findings suggest that randomised, controlled trials in clinical orthopaedic research utilise sample sizes which are too small to ensure statistical significance for what may be clinically important results

We have previously reported the short-term radiological results of a randomised controlled trial comparing kinematically aligned total knee replacement (TKR) and mechanically aligned TKR, along with early pain and function scores. In this study we report the two-year clinical results from this trial. A total of 88 patients (88 knees) were randomly allocated to undergo either kinematically aligned TKR using patient-specific guides, or mechanically aligned TKR using conventional instruments. They were analysed on an intention-to-treat basis. The patients and the clinical evaluator were blinded to the method of alignment. At a minimum of two years, all outcomes were better for the kinematically aligned group, as determined by the mean Oxford knee score (40 (15 to 48) versus 33 (13 to 48); p = 0.005), the mean Western Ontario McMaster Universities Arthritis index (WOMAC) (15 (0 to 63) versus 26 (0 to 73); p = 0.005), mean combined Knee Society score (160 (93 to 200) versus 137 (64 to 200); p= 0.005) and mean flexion of 121° (100 to 150) versus 113° (80 to 130) (p = 0.002). The odds ratio of having a pain-free knee at two years with the kinematically aligned technique (Oxford and WOMAC pain scores) was 3.2 (p = 0.020) and 4.9 (p = 0.001), respectively, compared with the mechanically aligned technique. Patients in the kinematically aligned group walked a mean of 50 feet further in hospital prior to discharge compared with the mechanically aligned group (p = 0.044). In this study, the use of a kinematic alignment technique performed with patient-specific guides provided better pain relief and restored better function and range of movement than the mechanical alignment technique performed with conventional instruments. Cite this article: Bone Joint J 2014;96-B:907–13

The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in total knee replacement in the absence of patellar resurfacing. Patients requiring knee replacement for primary osteoarthritis were randomly assigned circumpatellar electrocautery (intervention group) or no electrocautery (control group). The primary outcome measure was the incidence of anterior knee pain. A secondary measure was the standardised clinical and patient-reported outcomes determined by the American Knee Society scores and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. A total of 131 knees received circumpatellar electrocautery and 131 had no electrocautery. The overall incidence of anterior knee pain at follow-up at one year was 26% (20% to 31%), with 19% (12% to 26%) in the intervention group and 32% (24% to 40%) in the control group (p = 0.02). The relative risk reduction from electrocautery was 40% (9% to 61%) and the number needed to treat was 7.7 (4.3 to 41.4). The intervention group had a better mean total WOMAC score at follow-up at one year compared with the control group (16.3 (0 to 77.7) versus 21.6 (0 to 76.7), p = 0.04). The mean post-operative American Knee Society knee scores and function scores were similar in the intervention and control groups (knee score: 92.4 (55 to 100) versus 90.4 (51 to 100), respectively (p = 0.14); function score: 86.5 (15 to 100) versus 84.5 (30 to 100), respectively (p = 0.49)). Our study suggests that in the absence of patellar resurfacing electrocautery around the margin of the patella improves the outcome of total knee replacement

Objectives. Nylon sutures and skin staples are used commonly in total knee arthroplasty (TKA) surgical wound closure. However, there is no study that compares the wound healing efficacy and patient satisfaction scores of both techniques in the same knee. Methods. We randomised 70 patients who underwent primary TKA into two groups. In one group of 34 patients, the skin at the upper half of the wound was closed with skin staples and the lower half of the wound was closed with simple interrupted nylon sutures. In the other group of 36 patients, the skin at the upper half of the wound was closed with nylon stitches and the lower half of the wound was closed with skin staples. We recorded the wound closure time, pain score at the time of stitch removal, wound complication rate, patient satisfaction score, and the Hollander wound evaluation score at the post-operative periods of five days, 14 days, six weeks, three months, and six months. Each half wound was analysed separately. Results. The mean patient body mass index was 26.8 kg/m. 2. (standard deviation 6.3). A total of 70 nylon stitched wounds and 70 skin stapled wounds were analysed. There were no significant differences in wound complication rates, patient satisfaction score, and the Hollander wound evaluation score between both types of wounds (p > 0.05). The wound closure time for skin stapled wounds was significantly lower than the nylon stitched wounds (p < 0.001). However, the skin stapled wounds had a significantly higher pain score at the time of stitch removal (p < 0.001). Conclusion. Skin staples and nylon stitches had comparable results with respect to wound healing and patient satisfaction in TKA wound closure in non-obese patients. The benefit of skin staples over nylon stitches was a decrease in operative time, but was more painful upon removal. Cite this article: V. Yuenyongviwat. A randomised controlled trial comparing skin closure in total knee arthroplasty in the same knee: nylon sutures versus skin staples. Bone Joint Res 2016;5:185–190. DOI: 10.1302/2046-3758.55.2000629

We report a prospective, randomised, controlled trial of the effect of either a non-steroidal anti-inflammatory drug (diclofenac sodium) or physiotherapy on the recovery of knee function after arthroscopy. At 42 days after surgery there was no significant benefit from either form of postoperative treatment compared with the control group. Complications attributable to the anti-inflammatory drug occurred in 9.6% of the patients so treated. Neither the routine administration of a non-steroidal anti-inflammatory agent nor routine physiotherapy is justified after arthroscopy of the knee

Most published randomised controlled trials which compare the rates of wear of conventional and cross-linked (XL) polyethylene (PE) in total hip arthroplasty (THA) have described their use with a cementless acetabular component. . We conducted a prospective randomised study to assess the rates of penetration of two distinct types of PE in otherwise identical cemented all-PE acetabular components. . A total of 100 consecutive patients for THA were randomised to receive an acetabular component which had been either highly XL then remelted or moderately XL then annealed. . After a minimum of eight years follow-up, 38 hips in the XL group and 30 hips in the annealed group had complete data (mean follow-up of 9.1 years (7.6 to 10.7) and 8.7 years (7.2 to 10.2), respectively). In the XL group, the steady state rate of penetration from one year onwards was -0.0002 mm/year (. sd. 0.108): in the annealed group it was 0.1382 mm/year (. sd. 0.129) (Mann–Whitney U test, p < 0.001). No complication specific to either material was recorded. These results show that the yearly linear rate of femoral head penetration can be significantly reduced by using a highly XLPE cemented acetabular component. Cite this article: Bone Joint J 2015;97-B:1458–62

The primary purpose of this study of metal-on-metal (MoM) hip resurfacing was to compare the effect of using a cementless or cemented femoral component on the subsequent bone mineral density (BMD) of the femoral neck.

This was a single-centre, prospective, double-blinded control trial which randomised 120 patients (105 men and 15 women) with a mean age of 49.4 years (21 to 68) to receive either a cemented or cementless femoral component. Follow-up was to two years. Outcome measures included total and six-point region-of-interest BMD of the femoral neck, radiological measurements of acetabular inclination, neck-shaft and stem-shaft angles, and functional outcome scores including the Harris hip score, the Western Ontario and McMaster Universities Osteoarthritis Index and the University of California at Los Angeles activity scale.

In total, 17 patients were lost to follow-up leaving 103 patients at two years. There were no revisions in the cementless group and three revisions (5%) in the cemented group (two because of hip pain and one for pseudotumour).

The total BMD was significantly higher in the cementless group at six months (p < 0.001) and one year (p = 0.01) than in the cemented group, although there was a loss of statistical significance in the difference at two years (p = 0.155).

All patient outcomes improved significantly: there were no significant differences between the two groups.

The results show better preservation of femoral neck BMD with a cementless femoral component after two years of follow-up. Further investigation is needed to establish whether this translates into improved survivorship.

Cite this article: Bone Joint J 2015;97-B:1608–14.

We describe the results of a randomised, prospective study of 200 ankle replacements carried out between March 2000 and July 2003 at a single centre to compare the Buechel-Pappas (BP) and the Scandinavian Total Ankle Replacement (STAR) implant with a minimum follow-up of 36 months. The two prostheses were similar in design consisting of three components with a meniscal polyethylene bearing which was highly congruent on its planar tibial surface and on its curved talar surface. However, the designs were markedly different with respect to the geometry of the articular surface of the talus and its overall shape.

A total of 16 ankles (18%) was revised, of which 12 were from the BP group and four of the STAR group. The six-year survivorship of the BP design was 79% (95% confidence interval (CI) 63.4 to 88.5 and of the STAR 95% (95% CI 87.2 to 98.1). The difference did not reach statistical significance (p = 0.09). However, varus or valgus deformity before surgery did have a significant effect) (p = 0.02) on survivorship in both groups, with the likelihood of revision being directly proportional to the size of the angular deformity. Our findings support previous studies which suggested that total ankle replacement should be undertaken with extreme caution in the presence of marked varus or valgus deformity.

Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.

In the absence of patellar resurfacing, we have previously shown that the use of electrocautery around the margin of the patella improved the one-year clinical outcome of total knee replacement (TKR). In this prospective randomised study we compared the mean 3.7 year (1.1 to 4.2) clinical outcomes of 300 TKRs performed with and without electrocautery of the patellar rim: this is an update of a previous report. The overall prevalence of anterior knee pain was 32% (95% confidence intervals [CI] 26 to 39), and 26% (95% CI 18 to 35) in the intervention group compared with 38% (95% CI 29 to 48) in the control group (chi-squared test; p = 0.06). The overall prevalence of anterior knee pain remained unchanged between the one-year and 3.7 year follow-up (chi-squared test; p = 0.12). The mean total Western Ontario McMasters Universities Osteoarthritis Indices and the American Knee Society knee and function scores at 3.7 years’ follow-up were similar in the intervention and control groups (repeated measures analysis of variance p = 0.43, p = 0.09 and p = 0.59, respectively). There were no complications. A total of ten patients (intervention group three, control group seven) required secondary patellar resurfacing after the first year.

Our study suggests that the improved clinical outcome with electrocautery denervation compared with no electrocautery is not maintained at a mean of 3.7 years’ follow-up.

Cite this article: Bone Joint J 2014;96-B:473–8.

The routine use of surgical drains in total hip arthroplasty remains controversial. They have not been shown to decrease the rate of wound infection significantly and can provide a retrograde route for it. Their use does not reduce the size or incidence of post-operative wound haematomas. This prospective, randomised study was designed to evaluate the role of drains in routine total hip arthroplasty.

We investigated 552 patients (577 hips) undergoing unilateral or bilateral total hip arthroplasty who had been randomised to either having a drain for 24 hours or not having a drain. All patients followed standardised pre-, intra-, and post-operative regimes and were independently assessed using the Harris hip score before operation and at six, 18 and 36 months follow-up.

The rate of superficial and deep infection was 2.9% and 0.4%, respectively, in the drained group and 4.8% and 0.7%, respectively in the undrained group. One patient in the undrained group had a haematoma which did not require drainage or transfusion. The rate of transfusion after operation in the drained group was significantly higher than for undrained procedures (p < 0.042). The use of a drain did not influence the post-operative levels of haemoglobin, the revision rates, Harris hip scores, the length of hospital stay or the incidence of thromboembolism. We conclude that drains provide no clear advantage at total hip arthroplasty, represent an additional cost, and expose patients to a higher risk of transfusion.

We report the long-term survival of a prospective randomised consecutive series of 501 primary knee replacements using the press-fit condylar posterior cruciate ligament-retaining prosthesis. Patients received either cemented (219 patients, 277 implants) or cementless (177 patients, 224 implants) fixation. Altogether, 44 of 501 knees (8.8%) underwent revision surgery (24 cemented vs 20 cementless). For cemented knees the 15-year survival rate was 80.7% (95% confidence interval (CI) 71.5 to 87.4) and for cementless knees it was 75.3% (95% CI 63.5 to 84.3). There was no significant difference between the two groups (cemented vs cementless; hazard ratio (HR) 0.83, 95% CI 0.45 to 1.52, p = 0.55). When comparing the covariates there was no significant difference in the rates of survival between the side of operation (HR 0.58, p = 0.07), age (HR 0.97, p = 0.10) and diagnosis (HR 1.25 p = 0.72). However, there was a significant gender difference, with males having a higher failure rate with cemented fixation (HR 2.48, p = 0.004). Females had a similar failure rate in both groups.

This single-surgeon series, with no loss to follow-up, provides reliable data of the revision rates of one of the most commonly-used total knee replacements. The survival of the press-fit condylar total knee replacement remained good at 15 years, irrespective of the method of fixation.

We have carried out a long-term survival analysis of a prospective, randomised trail comparing cemented with cementless fixation of press-fit condylar primary total knee replacements. A consecutive series of 501 replacements received either cemented (219 patients, 277 implants) or cementless (177 patients, 224 implants) fixation.

The patients were contacted at a mean follow-up of 7.4 years (2.7 to 13.0) to establish the rate of survival of the implant. The ten-year survival was compared using life-table and Cox’s proportional hazard analysis.

No patient was lost to follow-up. The survival at ten years was 95.3% (95% CI 90.3 to 97.8) and 95.6% (95% CI 89.5 to 98.2) in the cemented and cementless groups, respectively. The hazard ratio for failure in cemented compared with cementless prostheses was 0.97 (95% CI 0.36 to 2.6). A comparison of the clinical outcome at ten years in 80 knees showed no difference between the two groups.

The survival of the press-fit condylar total knee replacement at ten years is good irrespective of the method of fixation and brings into question the use of more expensive cementless implants.

We undertook a prospective controlled clinical trial of 109 patients to determine whether postoperative blood salvage in patients undergoing total hip or knee arthroplasty decreased the need for transfusion with banked blood. The average amount of blood collected in our series was 493 ml, most of which was collected in the first four postoperative hours. In patients undergoing bilateral total knee arthroplasty, there was a 54% reduction in banked blood utilisation. None of our patients developed adverse effects from the reinfused material. The cost of collecting and processing wound drainage using the Haemolite cell washer was $175 per patient, regardless of the volume processed, compared to $125 for a unit of banked blood. By reducing the requirement for homologous transfusion, blood salvage diminishes the risks of transmission of HIV and hepatitis viruses. In those cases where the equivalent of two units of blood are reinfused, blood salvage saves money. However, due to the small amounts of blood collected in unilateral hip or knee arthroplasty, we do not recommend its routine application in these cases.

Objectives

Local corticosteroid infiltration is a common practice of treatment for lateral epicondylitis. In recent studies no statistically significant or clinically relevant results in favour of corticosteroid injections were found. The injection of autologous blood has been reported to be effective for both intermediate and long-term outcomes. It is hypothesised that blood contains growth factors, which induce the healing cascade.

Objectives . A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results. All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion . In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40

The best treatment for the active and lucid elderly patient with a displaced intracapsular fracture of the femoral neck is still controversial. Randomised controlled trials have shown that a primary total hip replacement is superior to internal fixation as regards the need for secondary surgery, hip function and health-related quality of life. Despite good results achieved with total hip replacement in this group, most orthopaedic surgeons still advocate hemiarthroplasty for this injury. We studied 120 patients with a mean age of 81 years (70 to 90) with an acute displaced intracapsular fracture of the femoral neck. They were randomly allocated to be treated with either a bipolar hemiarthroplasty or total hip replacement. Outcome measurements included peri-operative data, general and hip-specific complications, hip function and health-related quality of life. The patients were reviewed at four and 12 months.

The duration of surgery was longer in the total hip replacement group (102 minutes (70 to 151)) versus 78 minutes (43 to 131) (p < 0.001), and the intra-operative blood loss was increased 460 ml (100 to 1100) versus 320 ml (50 to 850) (p < 0.001), but there were no differences between the groups regarding any complications or mortality. There were no dislocations in either group. Hip function measured by the Harris hip score was significantly better in the total hip replacement group at both follow-up periods (p = 0.011 and p < 0.001, respectively). The health-related quality of life measure was in favour of the total hip replacement group but did not reach statistical significance (p = 0.818 at four months and p = 0.636 at 12 months).

These results indicate that a total hip replacement provides better function than a bipolar hemiarthroplasty as soon as one year post-operatively, without increasing the complication rate. We recommend total hip replacement as the primary treatment for this group of patients.

The importance of registries has been brought into focus by recent UK national reports focusing on implant (Cumberlege) and surgeon (Paterson) performance. National arthroplasty registries provide real-time, real-world information about implant, hospital, and surgeon performance and allow case identification in the event of product recall or adverse surgical outcomes. They are a valuable resource for research and service improvement given the volume of data recorded and the longitunidal nature of data collection. This review discusses the current value of registry data as it relates to both clinical practice and research.

Cite this article: Bone Joint J 2023;105-B(4):356–360.

In a prospective study, 60 patients with acute acromioclavicular dislocation were randomly allocated to treatment with a broad arm sling or to reduction and fixation with a coracoclavicular screw. Of these 54 were followed for four years. Conservatively-treated patients regained movement significantly more quickly and fully, returned to work and sport earlier and had fewer unsatisfactory results than those having early operation. For severe dislocations, with acromioclavicular displacement of 2 cm or more, early surgery produced better results. Conservative management is best for most acute dislocations, but younger patients with severe displacement may benefit from early reduction and stabilisation.

Hip fracture is a common injury associated with high mortality, long-term disability and huge socio-economic burden. Yet there has been relatively little research into best treatment, and evidence that has been generated has often been criticised for its poor quality. Here, we discuss the advances made towards overcoming these criticisms and the future directions for hip fracture research: how co-ordinating existing national infrastructures and use of now established clinical research networks will likely go some way towards overcoming the practical and financial challenges of conducting large trials. We highlight the importance of large collaborative pragmatic trials to inform decision/policy makers and the progress made towards reaching a consensus on a core outcome set to facilitate data pooling for evidence synthesis and meta-analysis.

These advances and future directions are a priority in order to establish the high-quality evidence base required for this important group of patients.

Cite this article: Bone Joint J 2015;97-B:875–9.

Objectives. The objective of this study was to assess all evidence comparing the Thompson monoblock hemiarthroplasty with modular unipolar implants for patients requiring hemiarthroplasty of the hip with respect to mortality and complications. Methods. A literature search was performed to identify all relevant literature. The population consisted of patients undergoing hemiarthroplasty of the hip for fracture. The intervention was hemiarthroplasty of the hip with a comparison between Thompson and modular unipolar prostheses. Pubmed, Embase, CINAHL, Web of Science, PROSPERO and the Cochrane Central Register of Controlled Trials. The study designs included were randomised controlled trials (RCTs), well designed case control studies and retrospective or prospective cohort studies. Studies available in any language, published at any time until September 2015 were considered. Studies were included if they contained mortality or complications. Results. The initial literature search identified 4757 items for examination. Four papers were included in the final review. The pooled odds ratio for mortality was 1.3 (95% confidence Interval 0.78 to 2.46) favouring modular designs. The pooled odds ratio for post-operative complications was 1.1 (95% CI 0.79 to 1.55) favouring modular designs. Outcomes were reported at 12 or six months. These papers all contained potential sources of bias and significant clinical heterogeneity. Conclusion. The current evidence comparing monoblock versus modular implants in patients undergoing hemiarthroplasty is weak. Confidence intervals around the pooled odds ratios are broad and incorporate a value of one. Direct comparison of outcomes from these papers is fraught with difficulty and, as such, may well be misleading. A well designed randomised controlled trial would be helpful to inform evidence-based implant selection. Cite this article: A. L. Sims, A. J. Farrier, M. R. Reed, T. A. Sheldon. Thompson hemiarthroplasty versus modular unipolar implants for patients requiring hemiarthroplasty of the hip: A systematic review of the evidence. Bone Joint Res 2017;6:–513. DOI: 10.1302/2046-3758.68.BJR-2016-0256.R1

Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders. Conclusions. The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423–432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1

Aims. Patients with osteoarthritis of the knee commonly have degenerative meniscal tears. Arthroscopic meniscectomy is frequently performed, although the benefits are debatable. Recent studies have concluded that there is no role for arthroscopic washout in osteoarthritis of the knee. Our aim was to perform a systematic review to assess the evidence for the efficacy of arthroscopic meniscectomy in patients with meniscal tears and degenerative changes in the knee. Patients and Methods. A literature search was performed, using the PubMed/MEDLINE database, for relevant articles published between 1975 and 2015. A total of six studies, including five randomised controlled trials and one cross-sectional study of a prospective cohort, met the inclusion criteria. Relevant information including study design, operations, the characteristics of the patients, outcomes, adverse events and further operations were extracted. Results. The degree of osteoarthritis in the patients who were included and the rate of cross over from one form of treatment to another varied in the studies. Two randomised controlled trials showed a benefit of arthroscopic surgery in patients with limited degenerative joint disease, compared with conservative treatment. One cross-sectional study showed that patients with less severe degenerative changes had better outcomes. Conclusion. Patients with symptomatic meniscal tears and degenerative changes in the knee can benefit from arthroscopic meniscectomy, particularly if the osteoarthritis is mild. A trial of conservative management may be effective and should be considered, especially in patients with moderate osteoarthritis. Cite this article: Bone Joint J 2016;98-B:934–8

Objectives. Wound complications are reported in up to 10% hip and knee arthroplasties and there is a proven association between wound complications and deep prosthetic infections. In this randomised controlled trial (RCT) we explore the potential benefits of a portable, single use, incisional negative pressure wound therapy dressing (iNPWTd) on wound exudate, length of stay (LOS), wound complications, dressing changes and cost-effectiveness following total hip and knee arthroplasties. Methods. A total of 220 patients undergoing elective primary total hip and knee arthroplasties were recruited into in a non-blinded RCT. For the final analysis there were 102 patients in the study group and 107 in the control group. Results. An improvement was seen in the study (iNPWTd) group compared to control in all areas. Peak post-surgical wound exudate was significantly reduced (p = 0.007). Overall LOS reduction (0.9 days, 95% confidence interval (CI) -0.2 to 2.5) was not significant (p = 0.07) but there was a significant reduction in patients with extreme values of LOS in the iNPWTd group (Moses test, p = 0.003). There was a significantly reduced number of dressing changes (mean difference 1.7, 95% CI 0.8 to 2.5, p = 0.002), and a trend to a significant four-fold reduction in reported post-operative surgical wound complications (8.4% control; 2.0% iNPWTd, p = 0.06). Conclusions. Based on the results of this RCT incisional negative pressure wound therapy dressings have a beneficial role in patients undergoing primary hip and knee arthroplasty to achieve predictable length of stay, especially to eliminate excessive hospital stay, and minimise wound complications. Cite this article: S. L. Karlakki, A. K. Hamad, C. Whittall, N. M. Graham, R. D. Banerjee, J. H. Kuiper. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res 2016;5:328–337. DOI: 10.1302/2046-3758.58.BJR-2016-0022.R1

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

Most patients with a nightstick fracture of the ulna are treated conservatively. Various techniques of immobilisation or early mobilisation have been studied. We performed a systematic review of all published randomised controlled trials and observational studies that have assessed the outcome of these fractures following above- or below-elbow immobilisation, bracing and early mobilisation. We searched multiple electronic databases, related bibliographies and other studies. We included 27 studies comprising 1629 fractures in the final analysis. The data relating to the time to radiological union and the rates of delayed union and nonunion could be pooled and analysed statistically. We found that early mobilisation produced the shortest radiological time to union (mean 8.0 weeks) and the lowest mean rate of nonunion (0.6%). Fractures treated with above- or below-elbow immobilisation and braces had longer mean radiological times to union (9.2 weeks, 9.2 weeks and 8.7 weeks, respectively) and higher mean rates of nonunion (3.8%, 2.1% and 0.8%, respectively). There was no statistically significant difference in the rate of non- or delayed union between those treated by early mobilisation and the three forms of immobilisation (p = 0.142 to p = 1.000, respectively). All the studies had significant biases, but until a robust randomised controlled trial is undertaken the best advice for the treatment of undisplaced or partially displaced nightstick fractures appears to be early mobilisation, with a removable forearm support for comfort as required. Cite this article: Bone Joint J 2013;95-B:952–9

Using meta-analysis we compared the survival and clinical outcomes of cemented and uncemented techniques in primary total knee replacement. We reviewed randomised controlled trials and observational studies comparing cemented and uncemented fixation. Our primary outcome was survival of the implant free of aseptic loosening. Our secondary outcome was joint function as measured by the Knee Society score. We identified 15 studies that met our final eligibility criteria. The combined odds ratio for failure of the implant due to aseptic loosening for the uncemented group was 4.2 (95% confidence interval (CI) 2.7 to 6.5) (p < 0.0001). Subgroup analysis of data only from randomised controlled trials showed no differences between the groups for odds of aseptic loosening (odds ratio 1.9, 95% CI 0.55 to 6.40, p = 0.314). The weighted mean difference for the Knee Society score was 0.005 (95% CI −0.26 to 0.26) (p = 0.972). There was improved survival of the cemented compared to uncemented implants, with no statistically significant difference in the mean Knee Society score between groups for all pooled data

The February 2015 Foot & Ankle Roundup. 360. looks at: Syndesmosis screw removal in randomised controlled trial; Diagnostic value of Hawkins sign; Chevron rules supreme?; Diabetes and ankle replacement; Fixed-bearing ankle replacement; Fusion for osteomyelitis of the ankle; ‘Reformed’ fallers

Aims. Rotator cuff tendinopathy has a multifactorial origin. Rejecting the mechanistic theory has also led to abandoning operative treatment at initial presentation in the first line. Physiotherapy exercise programmes are the accepted first line treatment. The aim of this study was to assess the long-term additional benefits of subacromial decompression in the treatment of rotator cuff tendinopathy. Patients and Methods. This randomised controlled trial of 140 patients (52 men, 88 women, mean age 47.1 years; 18 to 60) with rotator cuff tendinopathy extended previous work up to a maximum of 13 years. The patients were randomised into two treatment groups: arthroscopic acromioplasty and a supervised exercise treatment and a similar supervised exercise treatment alone. Self-reported pain on a visual analogue scale (VAS) was the primary outcome measure. Secondary measures were disability, working ability, pain at night, Shoulder Disability Questionnaire score and the number of painful days during the three months preceding the final assessment. Results. A total of 90 patients (64%) returned questionnaires at a mean 12 years after randomisation. On an intention-to-treat basis, both treatment groups reached statistically significant improvement compared with the initial VAS for pain, but there was no significant difference between groups. The same was true in the secondary outcome measures. Due to group changes, the results were also analysed per protocol: operated or not. No significant differences between the groups were found. Conclusion. The natural history of rotator cuff tendinopathy probably plays a significant role in the results in the long-term. Even though the patients who underwent operative treatment had a stronger belief in recovery, which is likely to be surgical and the effect of placebo, the exercise group obtained similar results. In the future, an optimum exercise regime should be searched for, as the most clinically and cost-effective conservative treatment for rotator cuff tendinopathy. Cite this article: Bone Joint J 2017;99-B:799–805

Aims. The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years. Patients and Methods. Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year. Results. A total of 19 patients were randomised to non-operative (n = 8) or operative (n = 11; tension-band wiring (n = 9), plate (n = 2)) management. The trial was stopped prematurely as the rate of complications (nine out of 11, 81.8%) in the operative group was considered to be unacceptable. There was, however, no difference in the mean DASH scores between the groups at all times. The mean score was 23 (0 to 59.6) in the non-operative group and 22 (2.5 to 57.8) in the operative group, one year after the injury (p = 0.763). There was no significant difference between groups in the secondary outcome measures of the Broberg and Morrey Score or the Mayo Elbow Score at any time during the one year following injury (all p ≥ 0.05). . Conclusion. These data further support the role of primary non-operative management of isolated displaced fractures of the olecranon in the elderly. However, the non-inferiority of non-operative management cannot be proved as the trial was stopped prematurely. Cite this article: Bone Joint J 2017;99-B:964–72

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. 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

Aims. This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. Patients and Methods. Data for patients’ use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. Results. With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. Conclusion. At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526–32

Aims. This is a prospective randomised controlled trial comparing the functional outcomes of plate fixation and elastic stable intramedullary nailing (ESIN) of completely displaced mid-shaft fractures of the clavicle in the active adult population. Patients and Methods. We prospectively recruited 123 patients and randomised them to either plate fixation or ESIN. Patients completed the Quick Disabilities of the Arm, Shoulder and Hand (DASH) score at one to six weeks post-operatively. They were followed up at six weeks, three and six months and one year with radiographs, and their clinical outcome was assessed using both the DASH and the Constant Score. Results. Plate fixation provided a faster functional recovery during the first six months compared with ESIN, but there was no difference after one year. The duration of surgery was shorter for ESIN (mean 53.4 minutes, 22 to 120) than for plate fixation (mean 69.7 minutes, 35 to 106, p < 0.001). The recovery after ESIN was slower with increasing fracture comminution and with open reduction (p < 0.05). Conclusion. Both methods return the patients to their pre-injury functional levels, but plate fixation has a faster recovery period in comminuted fractures than ESIN. ESIN has a shorter operative time and lower infection and implant rates of failure when using 2.5 mm nails or wider, suggesting that this is the preferred method in mid-shaft fractures with no comminution, whereas plate fixation is the superior method in comminuted fractures. Cite this article: Bone Joint J 2017;99-B:1095–1101

Osteoporotic vertebral compression fractures (VCFs) are an increasing public health problem. Recently, randomised controlled trials on the use of kyphoplasty and vertebroplasty in the treatment of these fractures have been published, but no definitive conclusions have been reached on the role of these interventions. The major problem encountered when trying to perform a meta-analysis of the available studies for the use of cementoplasty in patients with a VCF is that conservative management has not been standardised. Forms of conservative treatment commonly used in these patients include bed rest, analgesic medication, physiotherapy and bracing. . In this review, we report the best evidence available on the conservative care of patients with osteoporotic VCFs and associated back pain, focusing on the role of the most commonly used spinal orthoses. Although orthoses are used for the management of these patients, to date, there has been only one randomised controlled trial published evaluating their value. Until the best conservative management for patients with VCFs is defined and standardised, no conclusions can be drawn on the superiority or otherwise of cementoplasty techniques over conservative management

We have updated our previous randomised controlled trial comparing release of chromium (Cr) and cobalt (Co) ions and included levels of titanium (Ti) ions. We have compared the findings from 28 mm metal-on-metal total hip replacement, performed using titanium CLS/Spotorno femoral components and titanium AlloFit acetabular components with Metasul bearings, with Durom hip resurfacing using a Metasul articulation or bearing and a titanium plasma-sprayed coating for fixation of the acetabular component. Although significantly higher blood ion levels of Cr and Co were observed at three months in the resurfaced group than in total hip replacement, no significant difference was found at two years post-operatively for Cr, 1.58 μg/L and 1.62 μg/L respectively (p = 0.819) and for Co, 0.67 μg/L and 0.94 μg/L respectively (p = 0.207). A steady state was reached at one year in the resurfaced group and after three months in the total hip replacement group. Interestingly, Ti, which is not part of the bearing surfaces with its release resulting from metal corrosion, had significantly elevated ion levels after implantation in both groups. The hip resurfacing group had significantly higher Ti levels than the total hip replacement group for all periods of follow-up. At two years the mean blood levels of Ti ions were 1.87 μg/L in hip resurfacing and and 1.30 μg/L in total hip replacement (p = 0.001). The study confirms even with different bearing diameters and clearances, hip replacement and 28 mm metal-on-metal total hip replacement produced similar Cr and Co metal ion levels in this randomised controlled trial study design, but apart from wear on bearing surfaces, passive corrosion of exposed metallic surfaces is a factor which influences ion concentrations. Ti plasma spray coating the acetabular components for hip resurfacing produces significantly higher release of Ti than Ti grit-blasted surfaces in total hip replacement

Aims. There are two techniques widely used to determine the rotational alignment of the components in total knee arthroplasty (TKA); gap balancing (GB) and measured resection (MR). Which technique is the best remains controversial. We aimed to investigate this in a systematic review and meta-analysis. Materials and Methods. In accordance with the methods of Cochrane, databases were searched for all randomised controlled trials in the literature between January 1986 and June 2015 comparing radiographic and clinical outcomes between the use of these two tecniques. Meta-analysis involved the use of the Revman5.3 software provided by Cochrane collaboration. Results. A total of 1464 papers were initially identified, and after the application of rigourous inclusion and exclusion critera, eight were included in the study. In total they inolved 980 TKAs. The meta-analysis showed that GB techniques resulted in statistically significant improvements in the restoration of mechanical and rotational alignment and mean Knee Society Scores and Knee Society Function scores two years post-operatively, but resulted in greater elevation of the position of the joint line. There is no significant difference in the other radiographic data. Conclusion. This study suggests that GB may provide better radiographic and clinical outcomes than MR when used to determine mechanical rotation in TKAs. Cite this article: Bone Joint J 2017;99-B:151–8

Aims. We conducted a randomised controlled trial to assess the accuracy of positioning and alignment of the components in total knee arthroplasty (TKA), comparing those undertaken using standard intramedullary cutting jigs and those with patient-specific instruments (PSI). Patients and Methods. There were 64 TKAs in the standard group and 69 in the PSI group. The post-operative hip-knee-ankle (HKA) angle and positioning was investigated using CT scans. Deviation of > 3° from the planned position was regarded as an outlier. The operating time, Oxford Knee Scores (OKS) and Short Form-12 (SF-12) scores were recorded. Results. There were 14 HKA-angle outliers (22%) in the standard group and nine (13%) in the PSI group (p = 0.251). The mean HKA-angle was 0.5° varus in the standard group and 0.2° varus in the PSI group (p = 0.492). The accuracy of alignment in the coronal and axial planes and the proportion of outliers was not different in the two groups. The femoral component was more flexed (p = 0.035) and there were significantly more tibial slope outliers (29% versus 13%) in the PSI group (p = 0.032). Operating time and the median three-month OKS were similar (p = 0.218 and p = 0.472, respectively). Physical and mental SF-12 scores were not significantly different at three months (p = 0.418 and p = 0.267, respectively) or at one year post-operatively (p = 0.114 and p = 0.569). The median one-year Oxford knee score was two points higher in the PSI group (p = 0.049). Conclusion. Compared with standard intramedullary jigs, the use of PSI did not significantly reduce the number of outliers or the mean operating time, nor did it clinically improve the accuracy of alignment or the median Oxford Knee Scores. Our data do not support the routine use of PSI when undertaking TKA. Cite this article: Bone Joint J 2016;98-B:1043–9

Vertebral compression fractures are the most prevalent complication of osteoporosis and percutaneous vertebroplasty (PVP) has emerged as a promising addition to the methods of treating the debilitating pain they may cause. Since PVP was first reported in the literature in 1987, more than 600 clinical papers have been published on the subject. Most report excellent improvements in pain relief and quality of life. However, these papers have been based mostly on uncontrolled cohort studies with a wide variety of inclusion and exclusion criteria. In 2009, two high-profile randomised controlled trials were published in the New England Journal of Medicine which led care providers throughout the world to question the value of PVP. After more than two decades a number of important questions about the mechanism and the effectiveness of this procedure remain unanswered

Objectives. This study reports on a secondary exploratory analysis of the early clinical outcomes of a randomised clinical trial comparing robotic arm-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis of the knee with manual UKA performed using traditional surgical jigs. This follows reporting of the primary outcomes of implant accuracy and gait analysis that showed significant advantages in the robotic arm-assisted group. Methods. A total of 139 patients were recruited from a single centre. Patients were randomised to receive either a manual UKA implanted with the aid of traditional surgical jigs, or a UKA implanted with the aid of a tactile guided robotic arm-assisted system. Outcome measures included the American Knee Society Score (AKSS), Oxford Knee Score (OKS), Forgotten Joint Score, Hospital Anxiety Depression Scale, University of California at Los Angeles (UCLA) activity scale, Short Form-12, Pain Catastrophising Scale, somatic disease (Primary Care Evaluation of Mental Disorders Score), Pain visual analogue scale, analgesic use, patient satisfaction, complications relating to surgery, 90-day pain diaries and the requirement for revision surgery. Results. From the first post-operative day through to week 8 post-operatively, the median pain scores for the robotic arm-assisted group were 55.4% lower than those observed in the manual surgery group (p = 0.040). At three months post-operatively, the robotic arm-assisted group had better AKSS (robotic median 164, interquartile range (IQR) 131 to 178, manual median 143, IQR 132 to 166), although no difference was noted with the OKS. At one year post-operatively, the observed differences with the AKSS had narrowed from a median of 21 points to a median of seven points (p = 0.106) (robotic median 171, IQR 153 to 179; manual median 164, IQR 144 to 182). No difference was observed with the OKS, and almost half of each group reached the ceiling limit of the score (OKS > 43). A greater proportion of patients receiving robotic arm-assisted surgery improved their UCLA activity score. Binary logistic regression modelling for dichotomised outcome scores predicted the key factors associated with achieving excellent outcome on the AKSS: a pre-operative activity level > 5 on the UCLA activity score and use of robotic-arm surgery. For the same regression modelling, factors associated with a poor outcome were manual surgery and pre-operative depression. Conclusion. Robotic arm-assisted surgery results in improved early pain scores and early function scores in some patient-reported outcomes measures, but no difference was observed at one year post-operatively. Although improved results favoured the robotic arm-assisted group in active patients (i.e. UCLA ⩾ 5), these do not withstand adjustment for multiple comparisons. Cite this article: M. J. G. Blyth, I. Anthony, P. Rowe, M. S. Banger, A. MacLean, B. Jones. Robotic arm-assisted versus conventional unicompartmental knee arthroplasty: Exploratory secondary analysis of a randomised controlled trial. Bone Joint Res 2017;6:631–639. DOI: 10.1302/2046-3758.611.BJR-2017-0060.R1

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

We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene. The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I. 2. = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery

Oxidised zirconium (OxZi) has been developed as an alternative bearing surface for femoral heads in total hip arthroplasty (THA). This study has investigated polyethylene wear, functional outcomes and complications, comparing OxZi and cobalt–chrome (CoCr) as part of a three-arm, multicentre randomised controlled trial. Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and highly cross-linked polyethylene (XLPE) liner; Group B received an OxZi femoral head and XLPE liner; Group C received an OxZi femoral head and ultra-high molecular weight polyethylene (UHMWPE) liner. At five years, 368 patients had no statistically significant differences in short-form-36 (p = 0.176 mental, p = 0.756 physical), Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.847), pain scores (p = 0.458) or complications. The mean rate of linear wear was 0.028 mm/year (standard deviation (. sd) 0.010). for Group A, 0.023 mm/year (. sd. 0.010) for Group B, and 0.09 mm/year (. sd. 0.045) for Group C. Penetration was significantly higher in the UHMWPE liner group compared with both XLPE liner groups (p < 0.001) but no significant difference was noted between CoCr and OxZi when articulating with XLPE (p = 0.153). In this, the largest randomised study of this bearing surface, it appears that using a XLPE acetabular liner is more important in reducing THA component wear than the choice of femoral head bearing, at mid-term follow-up. There is a non-significant trend towards lower wear, coupling OxZi rather than CoCr with XLPE but long-term analysis is required to see if this observation changes with time and becomes significant. Cite this article: Bone Joint J 2015;97-B:883–9

Aims. This non-blinded randomised controlled trial compared the effect of patient-controlled epidural analgesia (PCEA) versus local infiltration analgesia (LIA) within an established enhanced recovery programme on the attainment of discharge criteria and recovery one year after total knee arthroplasty (TKA). The hypothesis was that LIA would increase the proportion of patients discharged from rehabilitation by the fourth post-operative day but would not affect outcomes at one year. Patients and Methods. A total of 242 patients were randomised; 20 were excluded due to failure of spinal anaesthesia leaving 109 patients in the PCEA group and 113 in the LIA group. Patients were reviewed at six weeks and one year post-operatively. Results. There was no difference in the proportion of patients discharged from rehabilitation by the fourth post-operative day, (77% in the PCEA group, 82% in the LIA group, p = 0.33), mean length of stay (four days in each group, p = 0.540), day of first mobilisation (p = 0.013) or pain (p = 0.278). There was no difference in mean Oxford Knee Scores (41 points in each group, p = 0.915) or the rate of complications in the two groups. Conclusion. Both techniques provided adequate pain relief, enabled early mobilisation and accelerated rehabilitation and good patient-reported outcomes up to one year post-operatively. PCEA and LIA are associated with similar clinical outcomes following TKA. Cite this article: Bone Joint J 2016;98-B1189–96

Not all questions can be answered by prospective randomised controlled trials. Registries were introduced as a way of collecting information on joint replacements at a population level. They have helped to identify failing implants and the data have also been used to monitor the performance of individual surgeons. This review aims to look at some of the less well known registries that are currently being used worldwide, including those kept on knee ligaments, ankle arthroplasty, fractures and trauma

Objectives. The period of post-operative treatment before surgical wounds are completely closed remains a key window, during which one can apply new technologies that can minimise complications. One such technology is the use of negative pressure wound therapy to manage and accelerate healing of the closed incisional wound (incisional NPWT). . Methods. We undertook a literature review of this emerging indication to identify evidence within orthopaedic surgery and other surgical disciplines. Literature that supports our current understanding of the mechanisms of action was also reviewed in detail. . Results. A total of 33 publications were identified, including nine clinical study reports from orthopaedic surgery; four from cardiothoracic surgery and 12 from studies in abdominal, plastic and vascular disciplines. Most papers (26 of 33) had been published within the past three years. Thus far two randomised controlled trials – one in orthopaedic and one in cardiothoracic surgery – show evidence of reduced incidence of wound healing complications after between three and five days of post-operative NPWT of two- and four-fold, respectively. Investigations show that reduction in haematoma and seroma, accelerated wound healing and increased clearance of oedema are significant mechanisms of action. . Conclusions. There is a rapidly emerging literature on the effect of NPWT on the closed incision. Initiated and confirmed first with a randomised controlled trial in orthopaedic trauma surgery, studies in abdominal, plastic and vascular surgery with high rates of complications have been reported recently. The evidence from single-use NPWT devices is accumulating. There are no large randomised studies yet in reconstructive joint replacement. Cite this article: Bone Joint Res 2013;2:276–84

Objectives. The Sliding Hip Screw (SHS) is commonly used to treat trochanteric hip fractures. Fixation failure is a devastating complication requiring complex revision surgery. One mode of fixation failure is lag screw cut-out which is greatest in unstable fracture patterns and when the tip-apex distance of the lag screw is > 25 mm. The X-Bolt Dynamic Hip Plating System (X-Bolt Orthopaedics, Dublin, Ireland) is a new device which aims to reduce this risk of cut-out. However, some surgeons have reported difficulty minimising the tip-apex distance with subsequent concerns that this may lead to an increased risk of cut-out. Patients and Methods. We measured the tip-apex distance from the intra-operative radiographs of 93 unstable trochanteric hip fractures enrolled in a randomised controlled trial (Warwick Hip Trauma Evaluation, WHiTE One trial). Participants were treated with either the sliding hip screw or the X-Bolt dynamic hip plating system. We also recorded the incidence of cut-out in both groups, at a median follow-up time of 17 months. Results. There was a significantly increased tip-apex distance with the use of the X-Bolt (mean difference 3.7mm (95% confidence interval 1.58 to 5.73); SHS mean 17.1 mm, X-Bolt mean 20.8; p = 0.001. However, this was not associated with an increased incidence of cut-out at a median follow-up time of 17 months, with three cut-outs (6%) in the SHS group and 0 (0%) in the X-Bolt group. Conclusion. The X-Bolt is a safe implant with no increased risk for cut-out. Concerns about minimising the tip-apex distance may be justified but do not appear to be clinically important. Cite this article: M. A. Fernandez, A. Aquilina, J. Achten, N. Parsons, M. L. Costa, X. L. Griffin. The tip-apex distance in the X-Bolt dynamic plating system. Bone Joint Res 2017;6:–207. DOI: 10.1302/2046-3758.64.BJR-2015-0016.R2

Aims. The aim of this study was to compare the Push Ortho Thumb Brace CMC and a custom-made orthosis in the treatment of patients with primary osteoarthritis of the carpometacarpal joint of the thumb. Our outcome measures were pain scores, tests of hand function, patient satisfaction and patient preference. Patients and Methods. A multicentre crossover randomised controlled trial was conducted which included 63 patients (44 women) with primary osteoarthritis of the carpometacarpal joint of the thumb. Of these, 59 patients with a mean age of 60.1 years (standard deviation 8.2), completed the study. Patients used both orthoses for two weeks with a two-week washout period in-between. Pain was measured on a 10-cm visual analogue scale. Hand function was assessed using the Jebsen Taylor Hand Function test, Nine Hole Peg Test, key grip, pinch grip and Functional Index for Hand Osteoarthritis. Patient preference was assessed using the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology score. Results. Both orthoses resulted in a minor reduction in pain scores without significant difference between the two orthoses. The Push Ortho Thumb Brace CMC interfered less with key grip (p < 0.001) and the Nine Hole Peg Test (p < 0.001) than the custom-made orthosis. The Push Ortho Thumb Brace CMC had a higher patient satisfaction (p < 0.001) and most patients preferred this orthosis for future use. Conclusion. When considering an orthosis for osteoarthritis of the carpometacarpal joint of the thumb, patients may prefer the Push Ortho Thumb Brace CMC. Cite this article: Bone Joint J 2017;99-B:237–44

We undertook a prospective randomised controlled trial involving 400 patients with a displaced intracapsular fracture of the hip to determine whether there was any difference in outcome between treatment with a cemented Thompson hemiarthroplasty and an uncemented Austin-Moore prosthesis. The surviving patients were followed up for between two and five years by a nurse blinded to the type of prosthesis used. The mean age of the patients was 83 years (61 to 104) and 308 (77%) were women. The degree of residual pain was less in those treated with a cemented prosthesis (p < 0.0001) three months after surgery. Regaining mobility was better in those treated with a cemented implant (p = 0.005) at six months after operation. No statistically significant difference was found between the two groups with regard to mortality, implant-related complications, re-operations or post-operative medical complications. The use of a cemented Thompson hemiarthroplasty resulted in less pain and less deterioration in mobility than an uncemented Austin-Moore prosthesis with no increase in complications

A delay in the diagnosis of paediatric acute and subacute haematogenous osteomyelitis can lead to potentially devastating morbidity. There are no definitive guidelines for diagnosis, and recommendations in the literature are generally based on expert opinions, case series and cohort studies. All articles in the English literature on paediatric osteomyelitis were searched using MEDLINE, CINAHL, EMBASE, Google Scholar, the Cochrane Library and reference lists. A total of 1854 papers were identified, 132 of which were examined in detail. All aspects of osteomyelitis were investigated in order to formulate recommendations. On admission 40% of children are afebrile. The tibia and femur are the most commonly affected long bones. Clinical examination, blood and radiological tests are only reliable for diagnosis in combination. Staphylococcus aureus is the most common organism detected, but isolation of Kingella kingae is increasing. Antibiotic treatment is usually sufficient to eradicate the infection, with a short course intravenously and early conversion to oral treatment. Surgery is indicated only in specific situations. Most studies were retrospective and there is a need for large, multicentre, randomised, controlled trials to define protocols for diagnosis and treatment. Meanwhile, evidence-based algorithms are suggested for accurate and early diagnosis and effective treatment

We compared patient-reported outcomes of the Kinemax fixed- and mobile-bearing total knee replacement in a multi-centre randomised controlled trial. Patients were randomised to the fixed- or the mobile-bearing prosthesis via a sealed envelope method after the bone cuts had been made in the operating theatre. Randomisation was stratified by centre and diagnosis. Patients were assessed pre-operatively and at eight to 12 weeks, one year and two years post-operatively. Validated questionnaires were used which included the Western Ontario MacMasters University, Short-Form 12, Mental Health Index-5, Knee Injury and Osteoarthritis Outcome Score for Knee-Related Quality of Life and Function in Sport and Recreation scales and a validated scale of satisfaction post-operatively. In total, 242 patients (250 knees) with a mean age of 68 years (40 to 80) were recruited from four NHS orthopaedic centres. Of these, 132 patients (54.5%) were women. No statistically significant differences could be identified in any of the patient-reported outcome scores between patients who received the fixed-bearing or the mobile-bearing knee up to two-years post-operatively

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

Objectives. Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making. Materials and Methods. A 29-question electronic survey was distributed to the readership of an established orthopaedic journal with international readership. The survey aimed to analyse the influence of both extrinsic (journal quality, investigator profiles, etc.) and intrinsic characteristics (study design, sample size, etc.) of research studies in relation to their influence on practice patterns. Results. A total of 353 surgeons completed the survey. Surgeons achieved consensus on the ‘importance’ of three key designs on their practices: randomised controlled trials (94%), meta-analyses (75%) and systematic reviews (66%). The vast majority of respondents support the use of current evidence over historical clinical training; however subjective factors such as journal reputation (72%) and investigator profile (68%) continue to influence clinical decision-making strongly. Conclusion. Although intrinsic factors such as study design and sample size have some influence on clinical decision-making, surgeon respondents are equally influenced by extrinsic factors such as investigator reputation and perceived journal quality. Cite this article: Dr M. Ghert. An international survey to identify the intrinsic and extrinsic factors of research studies most likely to change orthopaedic practice. Bone Joint Res 2016;5:130–136. DOI: 10.1302/2046-3758.54.2000578

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. . There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively. . NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture. Cite this article: Bone Joint J 2015;97-B:1264–70

Aims. A pragmatic multicentre randomised controlled trial (PROFHER) was conducted in United Kingdom National Health Service (NHS) hospitals to evaluate the clinical effectiveness and cost effectiveness of surgery compared with non-surgical treatment for displaced fractures of the proximal humerus involving the surgical neck in adults. . Methods. A cost utility analysis from the NHS perspective was performed. Differences between surgical and non-surgical treatment groups in costs and quality adjusted life years (QALYs) at two years were used to derive an estimate of the cost effectiveness of surgery using regression methods. . Results. Patients randomised to receive surgical intervention accumulated mean greater costs and marginally lower QALYs than patients randomised to non-surgery. The surgical intervention cost a mean of £1758 more per patient (95% confidence intervals (CI) £1126 to £2389). Total QALYs for the surgical group were smaller than those for non-surgery -0.0101 (95% CI -0.13 to 0.11). The probability of surgery being cost effective was less than 10% given the current NICE willingness to pay at a threshold of £20 000 for an additional QALY. The results were robust to sensitivity analyses. Discussion. The results suggest that current surgical treatment is not cost effective for the majority of displaced fractures of the proximal humerus involving the surgical neck in the United Kingdom’s NHS. Take home message: The results of this trial do not support the trend of increased surgical treatment for patients with displaced fractures of the proximal humerus involving the surgical neck within the United Kingdom NHS. Cite this article: Bone Joint J 2016;98-B:152–9

Objectives. High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). Methods. We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. Results. Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. Conclusions. This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance. Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint Res 2016;5:206–214. DOI: 10.1302/2046-3758.56.2000568

We report a systematic review and meta-analysis of published randomised controlled trials evaluating the efficacy of tranexamic acid (TXA) in reducing blood loss and transfusion in total hip replacement (THR). The data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. We identified 11 clinical trials which were suitable for detailed extraction of data. There were no trials that used TXA in revision THR. A total of seven studies (comprising 350 patients) were eligible for the blood loss outcome data. The use of TXA reduced intra-operative blood loss by a mean of 104 ml (95% confidence interval (CI) −164 to −44, p = 0.0006, heterogeneity I. 2. 0%), postoperative blood loss by a mean of 172 ml (95% CI −263 to −81, p = 0.0002, heterogeneity I. 2. 63%) and total blood loss by a mean of 289 ml (95% CI −440 to −138, p < 0.0002, heterogeneity I. 2. 54%). TXA led to a significant reduction in the proportion of patients requiring allogeneic blood transfusion (risk difference −0.20, 95% CI −0.29 to −0.11, p < 0.00001, I. 2. 15%). There were no significant differences in deep-vein thrombosis, pulmonary embolism, infection rates or other complications among the study groups

Randomised controlled trials (RCTs) that assessed the efficacy of bracing for adolescent idiopathic scoliosis have suffered from small sample sizes, low compliance and lack of willingness to participate. The aim of this study was to assess the feasibility of a comprehensive cohort study for evaluating both the efficacy and the effectiveness of bracing in patients with adolescent idiopathic scoliosis. Patients with curves at greater risk of progression were invited to join a randomised controlled trial. Those who declined were given the option to remain in the study and to choose whether they wished to be braced or observed. Of 87 eligible patients (5 boys and 63 girls) identified over one year, 68 (78%) with mean age of 12.5 years (10 to 15) consented to participate, with a mean follow-up of 168 weeks (0 to 290). Of these, 19 (28%) accepted randomisation. Of those who declined randomisation, 18 (37%) chose a brace. Patients who were more satisfied with their image were more likely to choose bracing (Odds Ratio 4.1; 95% confidence interval 1.1 to 15.0; p = 0.035). This comprehensive cohort study design facilitates the assessment of both efficacy and effectiveness of bracing in patients with adolescent idiopathic scoliosis, which is not feasible in a conventional randomised controlled trial. Cite this article: Bone Joint J 2015; 97-B:973–81

In a double-blinded randomised controlled trial, 83 patients with primary osteoarthritis of the hip received either a ceramic-on-metal (CoM) or metal-on-metal (MoM) total hip replacement (THR). The implants differed only in the bearing surfaces used. The serum levels of cobalt and chromium and functional outcome scores were compared pre-operatively and at six and 12 months post-operatively. Data were available for 41 CoM and 36 MoM THRs (four patients were lost to follow-up, two received incorrect implants). The baseline characteristics of both cohorts were similar. Femoral head size measured 36 mm in all but two patients who had 28 mm heads. The mean serum cobalt and chromium levels increased in both groups, with no difference noted between groups at six months (cobalt p = 0.67, chromium p = 0.87) and 12 months (cobalt p = 0.76, chromium p = 0.76) post-operatively. Similarly, the mean Oxford hip scores, Western Ontario and McMaster Universities Osteoarthritis index and University of California, Los Angeles activity scores showed comparable improvement at 12 months. Our findings indicate that CoM and MoM couplings are associated with an equivalent increase in serum cobalt and chromium levels, and comparable functional outcome scores at six and 12-months follow-up.

We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare the relative cost effectiveness of percutaneous Kirschner wire (K-wire) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius. . The cost effectiveness analysis (cost per quality-adjusted life year; QALY) was derived from a multi-centre, two-arm, parallel group, assessor-blind, randomised controlled trial which took place in 18 trauma centres in the United Kingdom. Data from 460 patients were available for analysis, which includes both a National Health Service cost perspective including costs of surgery, implants and healthcare resource use over a 12-month period after surgery, and a societal perspective, which includes the cost of time off work and the need for additional private care. . There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires. At a mean additional cost of £714 (95% confidence interval 588 to 865) per patient, locking-plate fixation presented an incremental cost effectiveness ratio (ICER) of £89 322 per QALY within the first 12 months of treatment. Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires. These were greater than £30 000. . Compared with locking-plate fixation, K-wire fixation is a ‘cost saving’ intervention, with similar health benefits. Cite this article: Bone Joint J 2015;97-B:1082–9

We reviewed the seven- to ten-year results of our previously reported prospective randomised controlled trial comparing total hip replacement and hemiarthroplasty for the treatment of displaced intracapsular fracture of the femoral neck. Of our original study group of 81 patients, 47 were still alive. After a mean follow up of nine years (7 to 10) overall mortality was 32.5% and 51.2% after total hip replacement and hemiarthroplasty, respectively (p = 0.09). At 100 months postoperatively a significantly greater proportion of hemiarthroplasty patients had died (p = 0.026). Three hips dislocated following total hip replacement and none after hemiarthroplasty. In both the total hip replacement and hemiarthroplasty groups a deterioration had occurred in walking distance (p = 0.02 and p < 0.001, respectively). One total hip replacement required revision compared with four hemiarthroplasties which were revised to total hip replacements. All surviving patients with a total hip replacement demonstrated wear of the cemented polyethylene component and all hemiarthroplasties had produced acetabular erosion. There was lower mortality (p = 0.013) and a trend towards superior function in patients with a total hip replacement in the medium term

Moderate to severe hallux valgus is conventionally treated by proximal metatarsal osteotomy. Several recent studies have shown that the indications for distal metatarsal osteotomy with a distal soft-tissue procedure could be extended to include moderate to severe hallux valgus. The purpose of this prospective randomised controlled trial was to compare the outcome of proximal and distal Chevron osteotomy in patients undergoing simultaneous bilateral correction of moderate to severe hallux valgus. The original study cohort consisted of 50 female patients (100 feet). Of these, four (8 feet) were excluded for lack of adequate follow-up, leaving 46 female patients (92 feet) in the study. The mean age of the patients was 53.8 years (30.1 to 62.1) and the mean duration of follow-up 40.2 months (24.1 to 80.5). After randomisation, patients underwent a proximal Chevron osteotomy on one foot and a distal Chevron osteotomy on the other. At follow-up, the American Orthopedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal interphalangeal (MTP-IP) score, patient satisfaction, post-operative complications, hallux valgus angle, first-second intermetatarsal angle, and tibial sesamoid position were similar in each group. Both procedures gave similar good clinical and radiological outcomes. This study suggests that distal Chevron osteotomy with a distal soft-tissue procedure is as effective and reliable a means of correcting moderate to severe hallux valgus as proximal Chevron osteotomy with a distal soft-tissue procedure. Cite this article: Bone Joint J 2015;97-B:202–7

We report the kinematic and early clinical results of a patient- and observer-blinded randomised controlled trial in which CT scans were used to compare potential impingement-free range of movement (ROM) and acetabular component cover between patients treated with either the navigated ‘femur-first’ total hip arthroplasty (THA) method (n = 66; male/female 29/37, mean age 62.5 years; 50 to 74) or conventional THA (n = 69; male/female 35/34, mean age 62.9 years; 50 to 75). The Hip Osteoarthritis Outcome Score, the Harris hip score, the Euro-Qol-5D and the Mancuso THA patient expectations score were assessed at six weeks, six months and one year after surgery. A total of 48 of the patients (84%) in the navigated ‘femur-first’ group and 43 (65%) in the conventional group reached all the desirable potential ROM boundaries without prosthetic impingement for activities of daily living (ADL) in flexion, extension, abduction, adduction and rotation (p = 0.016). Acetabular component cover and surface contact with the host bone were > 87% in both groups. There was a significant difference between the navigated and the conventional groups’ Harris hip scores six weeks after surgery (p = 0.010). There were no significant differences with respect to any clinical outcome at six months and one year of follow-up. The navigated ‘femur-first’ technique improves the potential ROM for ADL without prosthetic impingement, although there was no observed clinical difference between the two treatment groups. Cite this article: Bone Joint J 2015; 97-B:890–8

Objectives. As tumours of bone and soft tissue are rare, multicentre prospective collaboration is essential for meaningful research and evidence-based advances in patient care. The aim of this study was to identify barriers and facilitators encountered in large-scale collaborative research by orthopaedic oncological surgeons involved or interested in prospective multicentre collaboration. Methods. All surgeons who were involved, or had expressed an interest, in the ongoing Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial were invited to participate in a focus group to discuss their experiences with collaborative research in this area. The discussion was digitally recorded, transcribed and anonymised. The transcript was analysed qualitatively, using an analytic approach which aims to organise the data in the language of the participants with little theoretical interpretation. Results. The 13 surgeons who participated in the discussion represented orthopaedic oncology practices from seven countries (Argentina, Brazil, Italy, Spain, Denmark, United States and Canada). Four categories and associated themes emerged from the discussion: the need for collaboration in the field of orthopaedic oncology due to the rarity of the tumours and the need for high level evidence to guide treatment; motivational factors for participating in collaborative research including establishing proof of principle, learning opportunity, answering a relevant research question and being part of a collaborative research community; barriers to participation including funding, personal barriers, institutional barriers, trial barriers, and administrative barriers and facilitators for participation including institutional facilitators, leadership, authorship, trial set-up, and the support of centralised study coordination. Conclusions. Orthopaedic surgeons involved in an ongoing international randomised controlled trial (RCT) were motivated by many factors to participate. There were a number of barriers to and facilitators for their participation. There was a collective sense of fatigue experienced in overcoming these barriers, which was mirrored by a strong collective sense of the importance of, and need for, collaborative research in this field. The experiences were described as essential educational first steps to advance collaborative studies in this area. Knowledge gained from this study will inform the development of future large-scale collaborative research projects in orthopaedic oncology. Cite this article: J. S. Rendon, M. Swinton, N. Bernthal, M. Boffano, T. Damron, N. Evaniew, P. Ferguson, M. Galli Serra, W. Hettwer, P. McKay, B. Miller, L. Nystrom, W. Parizzia, P. Schneider, A. Spiguel, R. Vélez, K. Weiss, J. P. Zumárraga, M. Ghert. Barriers and facilitators experienced in collaborative prospective research in orthopaedic oncology: A qualitative study. Bone Joint Res 2017;6:–314. DOI: 10.1302/2046-3758.65.BJR-2016-0192.R1

We compared the incidence of pseudotumours after large head metal-on-metal (MoM) total hip arthroplasty (THA) with that after conventional metal-on-polyethylene (MoP) THA and assessed the predisposing factors to pseudotumour formation. . From a previous randomised controlled trial which compared large head (38 mm to 60 mm) cementless MoM THA with conventional head (28 mm) cementless MoP THA, 93 patients (96 THAs: 41 MoM (21 males, 20 females, mean age of 64 years, standard deviation (. sd. ) 4) and 55 MoP (25 males, 30 females, mean age of 65 years, . sd. 5) were recruited after a mean follow-up of 50 months (36 to 64). . The incidence of pseudotumours, measured using a standardised CT protocol was 22 (53.7%) after MoM THA and 12 (21.8%) after MoP THA. Women with a MoM THA were more likely to develop a pseudotumour than those with a MoP THA (15 vs 7, odds ratio (OR) = 13.4, p < 0.001). There was a similar incidence of pseudotumours in men with MoM THAs and those with MoP THAs (7 vs 5, OR = 2.1, p = 0.30). Elevated cobalt levels (≥ 5 microgram/L) were only associated with pseudotumours in women with a MoM THA. There was no difference in mean Oxford and Harris hip scores between patients with a pseudotumour and those without. . Contrary to popular belief, pseudotumours occur frequently around MoP THAs. Women with a MoM THA and an elevated cobalt level are at greatest risk. In this study, pseudotumours had no effect on the functional outcome after either large head MoM or conventional MoP THA. Cite this article: Bone Joint J 2015;97-B:1481–7

Objective. Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours. . Methods. We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens. . Results. We screened 96 patients and enrolled 60 participants (44 men and 16 women) across 21 sites from four countries over 24 months (mean 2.13 participants per site per year, standard deviation 2.14). One participant was lost to follow-up and one withdrew consent. Complete data were obtained for 98% of eligible patients at two weeks, 83% at six months, and 73% at one year (the remainder with partial data or pending queries). In total, 18 participants missed at least one dose of antibiotics or placebo post-operatively, but 93% of all post-operative doses were administered per protocol. . Conclusions. It is feasible to conduct a definitive multi-centre RCT of post-operative antibiotic regimens in patients with bone sarcomas, but further expansion of our collaborative network will be critical. We have demonstrated an ability to coordinate in multiple countries, enrol participants, maintain protocol adherence, and minimise losses to follow-up. Cite this article: Bone Joint Res;4:154–162

Objectives. To conduct a pilot randomised controlled trial to evaluate the feasibility of conducting a larger trial to evaluate the difference in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores at six months between patients with Achilles tendinopathy treated with a platelet-rich plasma (PRP) injection compared with an eccentric loading programme. Methods. Two groups of patients with mid-substance Achilles tendinopathy were randomised to receive a PRP injection or an eccentric loading programme. A total of 20 patients were randomised, with a mean age of 49 years (35 to 66). All outcome measures were recorded at baseline, six weeks, three months and six months. Results. The mean VISA-A score for the injection group at the primary endpoint of six months was 76.0 (95% confidence interval (CI) 58.3 to 93.7) and for the exercise group was 57.4 (95% CI 38.1 to 76.7). There was no statistically significant difference between these scores (p = 0.171), which was expected from such a pilot study. Conclusions. This pilot study has been key to providing data to inform a larger study and shows that the methodology is feasible. Cite this article: Bone Joint Res 2013;2:227–32

We have carried out a prospective double-blind randomised controlled trial to compare the efficacy of a single subacromial injection of the non-steroidal anti-inflammatory drug, tenoxicam, with a single injection of methylprednisolone in patients with subacromial impingement. A total of 58 patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and group B 20 mg of tenoxicam as a subacromial injection along with lignocaine. The Constant-Murley shoulder score was used as the primary outcome measure and the Disability of Arm, Shoulder and Hand (DASH) and the Oxford Shoulder Score (OSS) as secondary measures. Six weeks after injection the improvement in the Constant-Murley score was significantly greater in the methylprednisolone group (p = 0.003) than in the tenoxicam group. The improvement in the DASH score was greater in the steroid group and the difference was statistically significant and consistent two (p < 0.01), four (p < 0.01) and six weeks (p < 0.020) after the injection. The improvement in the OSS was consistently greater in the steroid group than in the tenoxicam group. Although the difference was statistically significant at two (p < 0.001) and four (p = 0.003) weeks after the injection, it was not at six weeks (p = 0.055). Subacromial injection of tenoxicam does not offer an equivalent outcome to subacromial injection of corticosteroid at six weeks. Corticosteroid is significantly better than tenoxicam for improving shoulder function in tendonitis of the rotator cuff after six weeks

We conducted a prospective randomised controlled trial to compare the standard Ponseti plaster method with an accelerated method for the treatment of idiopathic congenital talipes equinovarus. The standard weekly plaster-change method was accelerated to three times per week. We hypothesised that both methods would be equally effective in achieving correction. A total of 40 consecutive patients (61 feet) were entered into the trial. The initial median Pirani score was 5.5 (95% confidence interval 4.5 to 6.0) in the accelerated group and 5.0 (95% confidence interval 4.0 to 5.0) in the standard control group. The scores decreased by an average 4.5 in the accelerated group and 4.0 in the control group. There was no significant difference in the final Pirani score between the two groups (chi-squared test, p = 0.308). The median number of treatment days in plaster was 16 in the accelerated group and 42 in the control group (p < 0.001). Of the 19 patients in the accelerated group, three required plaster treatment for more than 21 days and were then assigned to the standard control method. Of the 40 patients, 36 were followed for a minimum of six months. These results suggest that comparable outcomes can be achieved with an accelerated Ponseti method. The ability to complete all necessary manipulations within a three-week period facilitates treatment where patients have to travel long distances

This was a safety study where the hypothesis was that the newer-design CPCS femoral stem would demonstrate similar early clinical results and micromovement to the well-established Exeter stem. Both are collarless, tapered, polished cemented stems, the only difference being a slight lateral to medial taper with the CPCS stem. A total of 34 patients were enrolled in a single-blinded randomised controlled trial in which 17 patients received a dedicated radiostereometric CPCS stem and 17 a radiostereometric Exeter stem. No difference was found in any of the outcome measures pre-operatively or post-operatively between groups. At two years, the mean subsidence for the CPCS stem was nearly half that seen for the Exeter stem (0.77 mm (−0.943 to 1.77) and 1.25 mm (0.719 to 1.625), respectively; p = 0.032). In contrast, the mean internal rotation of the CPCS stem was approximately twice that of the Exeter (1.61° (−1.07° to 4.33°) and 0.59° (0.97° to 1.64°), respectively; p = 0.048). Other migration patterns were not significantly different between the stems. The subtle differences in designs may explain the different patterns of migration. Comparable migration with the Exeter stem suggests that the CPCS design will perform well in the long term

In an initial randomised controlled trial (RCT) we segregated 180 patients to one of two knee positions following total knee replacement (TKR): six hours of knee flexion using either a jig or knee extension. Outcome measures included post-operative blood loss, fall in haemoglobin, blood transfusion requirements, knee range of movement, limb swelling and functional scores. A second RCT consisted of 420 TKR patients randomised to one of three post-operative knee positions: flexion for three or six hours post-operatively, or knee extension. Positioning of the knee in flexion for six hours immediately after surgery significantly reduced blood loss (p = 0.002). There were no significant differences in post-operative range of movement, swelling, pain or outcome scores between the various knee positions in either study. Post-operative knee flexion may offer a simple and cost-effective way to reduce blood loss and transfusion requirements following TKR. We also report a cautionary note regarding the potential risks of prolonged knee flexion for more than six hours observed during clinical practice in the intervening period between the two trials, with 14 of 289 patients (4.7%) reporting lower limb sensory neuropathy at their three-month review. Cite this article: Bone Joint J 2014;96-B:201–9

This was a randomised controlled trial studying the safety of a new short metaphyseal fixation (SMF) stem. We hypothesised that it would have similar early clinical results and micromovement to those of a standard-length tapered Synergy metaphyseal fixation stem. Using radiostereometric analysis (RSA) we compared the two stems in 43 patients. A short metaphyseal fixation stem was used in 22 patients and a Synergy stem in 21 patients. No difference was found in the clinical outcomes pre- or post-operatively between groups. RSA showed no significant differences two years post-operatively in mean micromovement between the two stems (except for varus/valgus tilt at p = 0.05) (subsidence 0.94 mm (. sd.  1.71) vs 0.32 mm (. sd. 0.45), p = 0.66; rotation 0.96° (. sd. 1.49) vs 1.41° (. sd. 2.95), p = 0.88; and total migration 1.09 mm (. sd. 1.74) vs 0.73 mm (. sd. 0.72), p = 0.51). A few stems (four SMF and three Synergy) had initial migration > 1.0 mm but stabilised by three to six months, with the exception of one SMF stem which required revision three years post-operatively. For most stems, total micromovement was very low at two years (subsidence < 0.5 mm, rotation < 1.0°, total migration < 0.5 mm), which was consistent with osseous ingrowth. The small sample makes it difficult to confirm the universal applicability of or elucidate the potential contraindications to the use of this particular new design of stem. Cite this article: Bone Joint J 2015; 97-B:595–602

The role of computer-assisted surgery in maintaining the level of the joint in primary knee joint replacement (TKR) has not been well defined. We undertook a blinded randomised controlled trial comparing joint-line maintenance, functional outcomes, and quality-of-life outcomes between patients undergoing computer-assisted and conventional TKR. A total of 115 patients were randomised (computer-assisted, n = 55; conventional, n = 60). Two years post-operatively no significant correlation was found between computer-assisted and conventional surgery in terms of maintaining the joint line. Those TKRs where the joint line was depressed post-operatively improved the least in terms of functional scores. No difference was detected in terms of quality-of-life outcomes. Change in joint line was found to be related to change in alignment. Change in alignment significantly affects change in joint line and functional scores

Intravenous tranexamic acid (TXA) has been shown to be effective in reducing blood loss and the need for transfusion after joint replacement. Recently, there has been interest in applying it topically before the closure of surgical wounds. This has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systemic absorption and, consequently, concerns about possible side-effects. We conducted a systematic review and meta-analysis which included 14 randomised controlled trials (11 in knee replacement, two in hip replacement and one in both) which investigated the effect of topical TXA on blood loss and rates of transfusion. Topical TXA significantly reduced the rate of blood transfusion (total knee replacement: risk ratio (RR) 4.51; 95% confidence interval (CI): 3.02 to 6.72; p < 0.001 (nine trials, I. 2 . = 0%); total hip replacement: RR 2.56; 95% CI: 1.32 to 4.97, p = 0.004 (one trial)). The rate of thromboembolic events with topical TXA were similar to those found with a placebo. Indirect comparison of placebo-controlled trials of topical and intravenous TXA indicates that topical administration is superior to the intravenous route. In conclusion, topical TXA is an effective and safe method of reducing the need for blood transfusion after total knee and hip replacement. Further research is required to find its optimum dose for topical use. Cite this article: Bone Joint J 2014;96-B:1005–15

Amin A, Watson A, Mangwani J, Nawabi DH, Ahluwalia R, Loeffler M. A prospective randomised controlled trial of autologous retransfusion in total knee replacement. Bone Joint J 2008;90-B:451–454

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar

We undertook a randomised controlled trial to compare the piriformis-sparing approach with the standard posterior approach used for total hip replacement (THR). We recruited 100 patients awaiting THR and randomly allocated them to either the piriformis-sparing approach or the standard posterior approach. Pre- and post-operative care programmes and rehabilitation regimes were identical for both groups. Observers were blinded to the allocation throughout; patients were blinded until the two-week assessment. Follow-up was at six weeks, three months, one year and two years. In all 11 patients died or were lost to follow-up. There was no significant difference between groups for any of the functional outcomes. However, for patients in the piriformis-sparing group there was a trend towards a better six-minute walk test at two weeks and greater patient satisfaction at six weeks. The acetabular components were less anteverted (p = 0.005) and had a lower mean inclination angle (p = 0.02) in the piriformis-sparing group. However, in both groups the mean component positions were within Lewinnek’s safe zone. Surgeons perceived the piriformis-sparing approach to be significantly more difficult than the standard approach (p = 0.03), particularly in obese patients. . In conclusion, performing THR through a shorter incision involving sparing piriformis is more difficult and only provides short-term benefits compared with the standard posterior approach

The anatomy and microstructure of the menisci allow the effective distribution of load across the knee. Meniscectomy alters the biomechanical environment and is a potent risk factor for osteoarthritis. Despite a trend towards meniscus-preserving surgery, many tears are irreparable, and many repairs fail. . Meniscal allograft transplantation has principally been carried out for pain in patients who have had a meniscectomy. Numerous case series have reported a significant improvement in patient-reported outcomes after surgery, but randomised controlled trials have not been undertaken. It is scientifically plausible that meniscal allograft transplantation is protective of cartilage, but this has not been established clinically to date. Cite this article: Bone Joint J 2015; 97-B:590–4

Aims. Multimodal infiltration of local anaesthetic provides effective control of pain in patients undergoing total knee arthroplasty (TKA). There is little information about the added benefits of posterior capsular infiltration (PCI) using different combinations of local anaesthetic agents. Our aim was to investigate the effectiveness of the control of pain using multimodal infiltration with and without infiltration of the posterior capsule of the knee. Patients and Methods. In a double-blind, randomised controlled trial of patients scheduled for unilateral primary TKA, 86 were assigned to be treated with multimodal infiltration with (Group I) or without (Group II) PCI. Routine associated analgesia included the use of bupivacaine, morphine, ketorolac and epinephrine. All patients had spinal anaesthesia and patient-controlled analgesia (PCA) post-operatively. A visual analogue scale (VAS) for pain and the use of morphine were recorded 24 hours post-operatively. Side effects of the infiltration, blood loss, and length of stay in hospital were recorded. Results. There were no statistically significant differences between the groups in relation to: VAS pain scores in the first 24 hours post-operatively (p = 0.693), the use of morphine in the PCA (p = 0.647), blood loss (p = 0.625), and length of stay (p = 0.17). There were no neurovascular complications in either group. Conclusion. The multimodal infiltration of local anaesthetic with infiltration of the posterior capsule did not provide significant added analgesic benefits or reduce the use of morphine after TKA. Multimodal infiltration is a satisfactory technique for the management of pain in these patients without the attendant risks of PCI. Cite this article: Bone Joint J 2017; 99-B:483–8

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

We performed a systematic review and meta-analysis of modern total ankle replacements (TARs) to determine the survivorship, outcome, complications, radiological findings and range of movement, in patients with end-stage osteoarthritis (OA) of the ankle who undergo this procedure. We used the methodology of the Cochrane Collaboration, which uses risk of bias profiling to assess the quality of papers in favour of a domain-based approach. Continuous outcome scores were pooled across studies using the generic inverse variance method and the random-effects model was used to incorporate clinical and methodological heterogeneity. We included 58 papers (7942 TARs) with an interobserver reliability (Kappa) for selection, performance, attrition, detection and reporting bias of between 0.83 and 0.98. The overall survivorship was 89% at ten years with an annual failure rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean American Orthopaedic Foot and Ankle Society score changed from 40 (95% CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up of 8.2 years (7 to 10) (p < 0.01). Radiolucencies were identified in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The mean total range of movement improved from 23° (95% CI 19 to 26) to 34° (95% CI 26 to 41) (p = 0.01). Our study demonstrates that TAR has a positive impact on patients’ lives, with benefits lasting ten years, as judged by improvement in pain and function, as well as improved gait and increased range of movement. However, the quality of evidence is weak and fraught with biases and high quality randomised controlled trials are required to compare TAR with other forms of treatment such as fusion. Cite this article: Bone Joint J 2013;95-B:1500–7

We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis

Bicruciate-stabilised total knee replacement (TKR) aims to restore normal kinematics by replicating the function of both cruciate ligaments. We performed a prospective, randomised controlled trial in which bicruciate- and posterior-stabilised TKRs were implanted in 13 and 15 osteo-arthritic knees, respectively. The mean age of the bicruciate-stabilised group was 63.9 years (. sd. 10.00) and that of the posterior-stabilised group 63.2 years (. sd. 6.7). A control group comprised 14 normal subjects with a mean age of 67.9 years (. sd. 7.9). The patellar tendon angle (PTA) was measured one week pre-operatively and at seven weeks post-operatively during knee extension, flexion and step-up exercises. At near full extension during step-up, the bicruciate-stabilised TKR produced a higher mean PTA than the posterior-stabilised TKR, indicating that the bicruciate design at least partially restored the kinematic role of the anterior cruciate ligament. The bicruciate-stabilised TKR largely restored the pre-operative kinematics, whereas the posterior-stabilised TKR resulted in a consistently lower PTA at all activities. The PTA in the pre-operative knees was higher than in the control group during the step-up and at near full knee extension. Overall, both groups generated a more normal PTA than that seen in previous studies in high knee flexion. This suggested that both designs of TKR were more effective at replicating the kinematic role of the posterior cruciate ligament than those used in previous studies

Cadossi M, Chiarello E, Savarino L, Tedesco G, Baldini N, Faldini C, Giannini S. A comparison of hemiarthroplasty with a novel polycarbonate-urethane acetabular component for displaced intracapsular fractures of the femoral neck: a randomised controlled trial in elderly patients. Bone Joint J 2013;95-B:609-615

A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year. The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance. Between January 2001 and April 2004, 92 patients were randomised to one or other of the techniques. At follow-up at one year the post-operative hip-knee-ankle angle was 3.4° (± 3.6° . sd. ) valgus after a closing wedge and 1.3° (± 4.7° . sd. ) of valgus after an opening wedge. The adjusted mean difference of 2.1° was significant (p = 0.02). The deviation from 4° of valgus alignment was 2.7° (± 2.4° . sd. ) in the closing wedge and 4.0° (± 3.6° . sd. ) in the opening-wedge groups. The adjusted mean difference of 1.67° was also significant (p = 0.01). The severity of pain, knee score and walking ability improved in both groups, but the difference was not significant. Because of pain, the staples required removal in 11 (23%) patients in the closing-wedge group and a Puddu plate was removed in 27 (60%) patients in the opening-wedge group. This difference was significant (p < 0.001). We conclude that closing-wedge osteotomy achieves a more accurate correction with less morbidity, although both techniques had improved the function of the knee at one year after the procedure

We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven

We performed a prospective, randomised controlled trial of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery. A total of 27 patients (28 knees) awaiting unicompartmental knee arthroplasty were randomly allocated to have the operation performed conventionally or with the assistance of the Acrobot. The primary outcome measurement was the angle of tibiofemoral alignment in the coronal plane, measured by CT. Other secondary parameters were evaluated and are reported. All of the Acrobot group had tibiofemoral alignment in the coronal plane within 2° of the planned position, while only 40% of the conventional group achieved this level of accuracy. While the operations took longer, no adverse effects were noted, and there was a trend towards improvement in performance with increasing accuracy based on the Western Ontario and McMaster Universities Osteoarthritis Index and American Knee Society scores at six weeks and three months. The Acrobot device allows the surgeon to reproduce a pre-operative plan more reliably than is possible using conventional techniques which may have clinical advantages

We conducted a randomised controlled trial to compare external fixation of trochanteric fractures of the femur with the more costly option of the sliding hip screw. Patients in both groups were matched for age (mean 67 years, 50 to 100) and gender. We excluded all pathological fractures, patients presenting at more than one week, fractures with subtrochanteric extension or reverse obliquity, multiple fractures or any bone and joint disease interfering with rehabilitation. The interval between injury and operation, the duration of surgery, the amount of blood loss, the length of hospital stay and the cost of treatment were all significantly higher in the sliding hip screw group (p < 0.05). The time to union, range of movement, mean Harris hip scores and Western Ontario and McMaster University knee scores were comparable at six months. The number of patients showing shortening or malrotation was too small to show a significant difference between the groups. Pin-track infection occurred in 18 patients (60%) treated with external fixation, whereas there was a single case of wound infection (3.3%) in the sliding hip screw group

Aims. There is uncertainty regarding the optimal means of thromboprophylaxis following total hip and knee arthroplasty (THA, TKA). This systematic review presents the evidence for acetylsalicylic acid (aspirin) as a thromboprophylactic agent in THA and TKA and compares it with other chemoprophylactic agents. Materials and Methods. A search of literature published between 2004 and 2014 was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 13 studies were eligible for inclusion. Results. Evidence from one good quality randomised controlled trial (RCT) showed no difference in rates of venous thrombo-embolism (VTE) in patients given aspirin or low molecular weight heparin (LMWH) following TKA. There was insufficient evidence from trials with moderate to severe risk of bias being present to suggest aspirin is more or less effective than LMWH, warfarin or dabigatran for the prevention of VTE in TKA or THA. Compared with aspirin, rates of asymptomatic deep vein thrombosis (DVT) in TKA may be reduced with rivaroxaban but insufficient evidence exists to demonstrate an effect on incidence of symptomatic DVT. Compared with aspirin there is evidence of more wound complications following THA and TKA with dabigatran and in TKA with rivaroxaban. Some studies highlighted concerns over bleeding complications and efficacy of aspirin. Conclusion. The results suggest aspirin may be considered a suitable alternative to other thromboprophylactic agents following THA and TKA. Further investigation is required to fully evaluate the safety and efficacy of aspirin. Cite this article: Bone Joint J 2016;98-B:1056–61

We compared the safety and outcome of one-stage bilateral total hip arthroplasty with those of a two-stage procedure during different admissions in a prospective, randomised controlled trial in an Asian population. Of 168 patients included in the study, 83 had a single- and 85 a two-stage procedure. Most of the patients (59.9%) suffered from inflammatory arthritis. The intra-operative complications, early systemic complications, the operating time, positioning of the components, the functional score, restoration of limb length and survival rates at 96 months were similar in the two groups. The total estimated blood loss was significantly lower in patients undergoing a one-stage procedure than in patients who had a two-stage procedure, but the transfusion requirements were significantly higher in the former group (p = 0.001). The hospital stay was significantly shorter in the one-stage group, 7.25 days (. sd. 1.30; 5 to 20) compared with 10 days (. sd. 1.65; 8 to 24) in the two-stage group (p = 0.023). We believe that a one-stage procedure is safe and appropriate in our population

We have evaluated the difference in the migration patterns over two years of two cementless stems in a randomised, controlled trial using radiostereophotogrammetric analysis (RSA). The implants studied were the Furlong HAC stem, which has good long-term results and the Furlong Active stem, which is a modified version of the former designed to minimise stress concentrations between the implant and bone, and thus to improve fixation. A total of 23 Furlong HAC and 20 Furlong Active stems were implanted in 43 patients. RSA examinations were carried out immediately post-operatively and at six, 12 and 24 months post-operatively. The subsidence during the first year in the Furlong HAC stem, was approximately one-third that of the Furlong Active stem, the measured mean subsidence of the femoral head at six months being 0.27 mm (95% confidence interval (CI) 0.03 to 0.51) and 0.99 mm (95% CI 0.38 to 1.60), respectively (p = 0.03). One Active stem continued to subside during the second year. All hips, regardless of the type of stem were clinically successful as judged by the Oxford hip score and a derived pain score without any distinction between the two types of stem. The initial stability of the Furlong Active stem was not as good as the established stem which might compromise osseo-integration to the detriment of long-term success. The changes in the geometry of the stem, to minimise stress have affected the attainment of initial stability

Aims. The role of high tibial osteotomy (HTO) is being questioned by the use of unicompartmental knee arthroplasty (UKA) in the treatment of medial compartment femorotibial osteoarthritis. Our aim was to compare the outcomes of revision HTO or UKA to a total knee arthroplasty (TKA) using computer-assisted surgery in matched groups of patients. Patients and Methods. We conducted a retrospective study to compare the clinical and radiological outcome of patients who underwent revision of a HTO to a TKA (group 1) with those who underwent revision of a medial UKA to a TKA (group 2). All revision procedures were performed using computer-assisted surgery. We extracted these groups of patients from our database. They were matched by age, gender, body mass index, follow-up and pre-operative functional score. The outcomes included the Knee Society Scores (KSS), radiological outcomes and the rate of further revision. Results. There were 20 knees in 20 patients in each group. The mean follow-up was 4.1 years (2 to 18.7). The mean total KSS at last follow-up was 185.7 (standard deviation (. sd. ) 5) in group 1 compared with 176.5 (. sd. 11) for group 2 (p = 0.003). The mean hip-knee-ankle angle was 180.2° (. sd. 3.2°) in group 1 and 179.0° (. sd. 2.2°) in group 2. No revision was required. Conclusion. We found that good functional and radiological outcomes followed revision of both HTO and UKA to TKA. Revision of HTO showed significantly better functional outcomes. These results need to be further investigated by a prospective randomised controlled trial involving a larger group of patients. Cite this article: Bone Joint J 2016;98-B:1620–4

Aims. This prospective randomised controlled trial was designed to evaluate the outcome of both the MRI- and CT-based patient-specific matched guides (PSG) from the same manufacturer. Patients and Methods. A total of 137 knees in 137 patients (50 men, 87 women) were included, 67 in the MRI- and 70 in the CT-based PSG group. Their mean age was 68.4 years (47.0 to 88.9). Outcome was expressed as the biomechanical limb alignment (centre hip-knee-ankle: HKA-axis) achieved post-operatively, the position of the individual components within 3° of the pre-operatively planned alignment, correct planned implant size and operative data (e.g. operating time and blood loss). Results. The patient demographics (e.g. age, body mass index), correct planned implant size and operative data were not significantly different between the two groups. The proportion of outliers in the coronal and sagittal plane ranged from 0% to 21% in both groups. Only the number of outliers for the posterior slope of the tibial component showed a significant difference (p = 0.004) with more outliers in the CT group (n = 9, 13%) than in the MRI group (0%). . Conclusion. The post-operative HKA-axis was comparable in the MRI- and CT-based PSGs, but there were significantly more outliers for the posterior slope in the CT-based PSGs. Take home message: Alignment with MRI-based PSG is at least as good as, if not better, than that of the CT-based PSG, and is the preferred imaging modality when performing TKA with use of PSG. Cite this article: Bone Joint J 2016;98-B:786–92

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161–8