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.

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 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.

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

Aims. To compare the structural durability of hydroxyapatite-tricalcium phosphate (HATCP) to autologous iliac crest bone graft in calcaneal lengthening osteotomy (CLO) for pes planovalgus in childhood. Patients and Methods. We present the interim results of ten patients (HATCP, n = 6 and autograft, n = 5) with a mean age of 11.5 years (8.2 to 14.2) from a randomised controlled non-inferiority trial with six months follow-up. The primary outcome was the stability of the osteotomy as measured by radiostereometric analysis. A non-inferiority margin of ≤ 2 mm osteotomy compression was set. Results. At six months the data showed that the osteotomy had been compressed by a mean 1.97 mm (99.8% confidence interval -1.65 to 5.60) more in the HATCP group than in the autograft group. Migration of the CLO grafted with HATCP stabilised at six months rather than at six weeks with autograft. Conclusion. This is the first randomised trial to compare the efficacy of HATCP graft with autograft in terms of stability of CLO in children. Because of problems with the HATCP the trial was stopped. We do not recommend HATCP graft in its current structure for use in unfixed CLOs. Cite this article: Bone Joint J 2016;98-B:1554–62

Aims

Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon.

A total of 56 male patients with a displaced intracapsular fracture of the hip and a mean age of 81 years (62 to 94), were randomised to be treated with either a cemented hemiarthroplasty (the Exeter Trauma Stem) or reduction and internal fixation using the Targon Femoral Plate. All surviving patients were reviewed one year after the injury, at which time restoration of function and pain in the hip was assessed. There was no statistically significant difference in mortality between the two groups (7/26; 26.9% for hemiarthroplasty vs 10/30; 33.3% for internal fixation). No patient treated with a hemiarthroplasty required further surgery, but eight patients treated by internal fixation did (p = 0.005), five requiring hemiarthroplasty and three requiring total hip arthroplasty. Those treated by internal fixation had significantly more pain (p = 0.02). The restoration of mobility and independence were similar in the two groups.

These results indicate that cemented hemiarthroplasty gives better results than internal fixation in elderly men with a displaced intracapsular fracture of the hip.

Cite this article: Bone Joint J 2015;97-B:992–6.

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

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

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 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

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

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. 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