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

There is ongoing debate on the benefits of fixed versus mobile bearing Unicompartmental Knee Replacement (UKR). We report the results from a randomised controlled trial comparing fixed and mobile bearing of the same UKR prosthesis. Forty patients were randomized to receive identical femoral components and either a fixed or mobile bearing tibial component. At 6.5 years follow-up 37% of the mobile bearing design had been revised and 14% for the fixed bearing design. The main reasons for revision were pain and loosening. These results were compared with data from The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) that show a cumulative percent revision of 24.2% for the mobile bearing Preservation UKR at 6.5 years. All locally explanted mobile bearings were examined microscopically, and 83% demonstrated significant backside wear. Constraint on the undersurface of the bearing coupled with a congruent upper surface may have contributed to the excessive revision rate. This is the first randomised controlled trial examining mobile and fixed variations of the same UKR prosthesis and shows this design of UKR with the mobile bearing has an unacceptably high revision rate and patients with this knee design should be closely monitored

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

Introduction. High flexion knee arthroplasties have been designed to allow up to 155 degrees flexion and enable high flexion activities such as kneeling and squatting. To date randomised controlled trials have shown no difference in range of movement (ROM) between high flexion and standard designs. Objectives. The aim of this study was to determine if there is a difference in functional outcome and ROM between the standard and high flexion design of the PFC Sigma TKA system. Methods. 84 patients with the diagnosis of osteoarthritis undergoing primary total knee arthroplasty were randomised to receive either a PFC Sigma or PFC Sigma RP-F total knee arthroplasty. ROM, Oxford Knee Score, Knee Society Score, Patella score and SF-12v2 were assessed independently before and at one year after surgery. Patients were blinded to the implant they received. Results. 42 patients in each group were included in this study and underwent surgery. 77 patients (92%) completed their one-year follow-up. There was no statistically significant difference in preoperative scores between groups. At one year there was a statistically significant difference in ROM between the groups with a mean of 105 degrees in the PFC Sigma and 114 degrees in the PFC Sigma RP-F group (p=0.01). There was also a statistically significant difference in flexion with 106 degrees and 115 degrees respectively (p=0.007). The difference in improvement in ROM and flexion was also statistically significant between the groups (p=0.009 and p=0.008). There was no statistically significant difference in any of the functional outcome scores. Conclusions. This is the first randomised controlled trial to show a statistically significant difference in ROM and flexion between a standard and a high flexion design TKA. Further follow-up will be carried out to determine if these differences persist over time and to evaluate the long-term survival of the different designs

Introduction. Many prosthetic design changes have been introduced in attempt to improve outcomes following TKA; however there is no consensus as to whether these changes confer benefits to patients. This study aimed to assess whether patients treated with a modern implant design had an enhanced patient outcome compared to a traditional model in a double blind randomised controlled trial. Methods. 212 consecutive patients were prospectively randomised to receive either a modern (Triathlon) or a traditional (Kinemax) TKA (both Stryker Orthopaedics). 6 surgeons at a single unit performed all procedures in a standardised manner. A single researcher, blinded to implant allocation, performed all assessments. Patients were assessed pre-operatively, and at 6, 26, 52 weeks post-surgery with the Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, goniometry, timed functional assessment, lower limb power (Leg Extensor Power Rig) and pain numerical rating scales (NRS). Change in scores and between group differences were assessed with Two-Way Repeated Measures ANOVAs. Results. Both groups benefited from TKA demonstrating significant improvement in all parameters (p = < 0.001 in all cases). Significant interaction of the implant was observed in 1 year change score of OKS (F = 4.28, p = 0.04), knee flexion (F = 8.42, p = 0.004), lower limb power output (F = 11.33, p = 0.001) and maximal pain report (F = 7.44, p = 0.001), the modern implant superior in each case. Larger change scores were observed in WOMAC and timed functional assessments, but were not statistically significant. Conclusions. In a large prospective double blind randomised controlled trial, patients receiving a modern implant design demonstrated a significantly enhanced patient outcome in terms of knee range of motion, lower limb power output, reduced maximal pain report, and a clinically meaningful reduction in the OKS compared to a traditional design

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

Platelet rich plasma has been advocated for the treatment of plantar fasciitis but there are few good quality clinical trials to support its use. We report a pilot double blind randomised controlled trial of platelet rich plasma versus normal saline. Methods. Patients with more than 6 months of MRI proven plantar fasciitis who had failed conservative management were invited to participate in this study. Patients were block randomised to either platelet rich plasma injection (intervention) or equivalent volume of normal saline (control). The techniques used for the injection and rehabilitation were standardised for both groups. The patient and independent assessor were blinded. Visual analogue scale for pain (VAS) and painDETECT were recorded pre-op and at 6 months. Results. Twenty-eight patients (19 females, mean age 50 years) were recruited, with 14 randomised to each arm. At 6 month follow-up, 8 patients (28.6%) were lost to follow-up. There was a significant change in VAS score from baseline to follow-up in both intervention (mean change 37.2, p = 0.008) and control (mean change 42.2, p = 0.003) groups. However there was no difference between the arms in terms of the change in VAS score from baseline to follow-up (p = 0.183). There was no correlation between pre-op PainDETECT score and change in VAS. Conclusion. This pilot study has failed to show a significant benefit of platelet rich plasma compared to saline injection, although both treatments have shown a significant improvement in symptoms. This may be due to the needling effect of injections. A larger study is required to demonstrate a meaningful change. Loss to follow in this patient group should be considered

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

Unicompartmental Knee Replacement (UKR) is associated with fewer complications, faster recovery and better function than Total Knee Replacement (TKR). However, joint registries demonstrate a higher revision rate in UKR, limiting its use. Currently most UKRs are cemented and performed using a minimally invasive technique. In joint registries, common reasons for revision include aseptic loosening and pain. These problems could potentially be addressed by using cementless implants, which may provide more reliable fixation. The objectives of this study were to compare the quality of fixation (determined by the incidence and appearance of radiolucencies), and clinical outcomes of cemented and cementless UKR at five years. A randomised controlled trial was established with 63 knees (62 patients) randomised to either cemented (32 patients) or cementless UKR (30 patients). Fixation was assessed with fluoroscopic radiographs aligned to the bone-implant interface at one and five years. Outcome scores were collected pre-operatively and at one, two and five years, including Oxford Knee Score (OKS), American Knee Society Score, objective and functional (AKSS-O/F) and Tegner Activity Scale (TAS), expressed as absolute scores and 0–5 year change (δ) scores. Four patients died during the study period. There were no revisions. Mean operative time was 11 minutes shorter in the cementless group (p=0.029). At five years, there was no significant difference in any outcome measure except AKSS-F and δAKSS-F which were significantly better in the cementless group (both p=0.003). There were no femoral radiolucencies in either group. There were significantly more tibial radiolucencies in the cemented group (20/30 vs 2/27, p< 0.001). There were nine complete radiolucencies in the cemented group and none in the cementless group (p< 0.001). Cementless fixation provides improved fixation at five years compared to cemented fixation in UKR, maintaining equivalent or superior clinical outcomes with a shorter operative time and no increase in complications

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.