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

Objectives. 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

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

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

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

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

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

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

Introduction. The aims of this study were to undertake a prospective randomised trial to compare functional outcome, strength and range of motion after treatment of medial collateral ligament injuries by either early unprotected mobilisation or mobilisation with a hinged brace. Methods. Patients were randomised into either unprotected mobilisation or mobilisation with a hinged brace. Assessments occurred at 2 weeks, 6 weeks, 3 months and 6 months. Outcome measures included validated questionnaires (International Knee Documentation Committee and Knee Injury and Osteoarthritis Outcome Score scores), range of motion measurements and strength testing. Results. Eighty six patients (mean age 30.4) were recruited. There were 53 men and 33 women. The mode of injury was sport in 56 patients (65%) with football, rugby and skiing being the most common types of sport involved. The mean time to return to full weight bearing was 3 weeks in both groups. The mean time to return to work was 4.6 weeks in the braced group and 4.1 weeks in the non-braced group (p=0.79). Return to running was at a mean of 14.3 weeks in the braced group and 12.8 weeks in the non-braced group (p=0.64). Return to full sport was 22 weeks in the braced group and 22.1 weeks in the non-braced group (p=0.99). There was no significant difference in range of movement or pain scores between the two groups at 2,6,12 and 24 weeks. Conclusions. The use of a hinged knee brace does not influence recovery after a medial collateral injury

Financial impact and patient satisfaction with four different anticoagulants for hip and knee arthroplasty in patients with a previous history of VTE- A prospective randomised trial. Introduction. New generation oral anticoagulants (dabigatran/rivaroxaban) have recently become available for the prevention of venous thromboembolism (VTE) following hip and knee arthroplasty. Traditional therapies (warfarin/low molecular weight heparins) are less costly, but have several limitations. The aim of this study was to evaluate the financial impact of substituting enoxaparin and warfarin with newer therapies dabigatran and rivaroxaban. A secondary objective was to investigate patient satisfaction with these treatments. Methods. A randomised prospective study was conducted over a 12 month period. Patients with a history of VTE undergoing hip or knee replacement were randomised to receive one of four anticoagulants for five weeks post surgery. Information was gathered during the hospital stay and then post discharge, by telephone, for five weeks(35 days)to determine costs. The costs included cost of drug, nursing time, blood monitoring and transport costs. The patients were also asked to complete the Duke Anticoagulation Satisfaction Scale (DASS). The DASS is a 26 item questionnaire which has 7 responses for each question. Results. Although dabigatran and rivaroxaban had higher drug acquisition costs, warfarin and enoxaparin were financially more costly overall. These additional costs were mainly due to increased blood monitoring and time for training and administration which is not required for newer therapies. DASS scores were significantly better with dabigatran (38.5±5.1) and rivaroxaban (38.6±8.3) compared to warfarin (71.8±16.2) and enoxaparin (68.5±14.2) (p< 0.001). This indicates more satisfaction for patients prescribed dabigatran or rivaroxaban compared to traditional therapies. Conclusion. The use of new generation oral anticoagulants has the potential to significantly reduce the financial burden of thromboprophylaxis on the NHS with an additional benefit of better patient satisfaction when compared to traditional therapies

Introduction. Viscosupplementation is used widely to provide symptomatic relief to patients with knee OA. This study aimed to compare the efficacy and safety of the standard (3×2ml) and single (1×6ml) dosing regimens of hylan G-F 20. Methods. Prospective, randomized, blinded (reviewers), comparative independent study. Inclusion criteria was OA knee pain e 60mm on a 100mm VAS; no prior intra articular (IA) injection. Patients were randomised to recieve 1 × 6mL or 3 × 2mL hylan G-F 20. Follow-up at 1, 6, 12, 26 and 52 weeks. Analgesics prohibited for 24 hours prior to follow-up assessments and NSAID's for 26 wks. All adverse events (AE) were recorded. Primary outcome measure: Target knee pain (VAS) at 26 weeks. Secondary outcome measures included WOMAC, Oxford knee score, SF12. Results. 412 patients were randomized (1 × 6mL N=194, 3 × 2 mL N=218). There were no significant differences in age, gender or grade of OA. Injection and/or treatment-related AE (all mild/moderate) were reported in 10.5% (3 × 2 mL) and 9.1% (1 × 6 mL) of patients Significant pain reduction was observed in both groups at 26 weeks (3 × 2 mL: 50% (mean) decrease, 1 × 6mL: 45%). There were no significant differences between groups for any of the primary or secondary outcome measures at 26 weeks. Discussion and Conclusion. Single dose of 6 mL hylan G-F 20 offer comparable safety and efficacy to 3 × 2 mL at 26 weeks. It provides both the patients and physicians a choice with the potential additional benefits of reduced operational costs

We report our five-year functional results comparing navigated and conventional total knee replacement. To our knowlege this represents the first Level 1 study comparing function in navigated and conventional total knee replacement at five years. An origianl cohort of 71 patients undergoing Duracon (Stryker Orthopaedics, St. Leonards, Australia) total knee replacement without patellar resurfacing were prospectively randomised to undergo operation using computer navigation (Stryker Image Free Computer Navigation System (version 1.0; Stryker Orthopaedics))(n=35) or a jig-based method (n=36). The two groups were matched for age, gender, height, weight, BMI, ASA grade abd pre-operative deformity. All operations were performed by a single surgeon. Reviews were undertaken by senior physiotherpist blinded to participant status using validated outcome scoring tools (Knee Society Score, WOMAC Score and Short Form SF-36 Score). All patients underwent CT scanning of the implanted prosthesis as per Perth CT Knee Protocol to assess component alignment. After 5 years 24 patients in the navigated group and 22 patients in the conventional group were available for review. At 5 years no statistically significant difference was seen in any of the aforementioned outcome scores when comparing navigated and conventional groups. No statistically significant differencewas seen between 2- and 5-year results for either group. Due to the relatively low numbers in each group these data were compared with retrospective cohorts of navigated (n=100) and conventional (n=70) Duracon total knee replacements performed outwith this study over the same 5-year period. WITHIN the retrospective cohorts no statistically significant differences were found when comparing any of the aforementioned outcome scores. In addition, when comparing parallel scores between prospective and retrospective groups again no statistically significant differences were identified. At 5-years post-operatively the functional outcome between computer navigated and conventional total knee replacement appears to be no different despite the better alignment achieved using navigation

Introduction. Debate continues regarding the relative advantages of ceramic-on-ceramic (CoC) and metal-on-polyethylene (MoP) articulations in total hip arthroplasty (THA). Perceived benefits of CoC include longevity, and low wear - in turn limiting the effects of particulate wear debris. However, CoC bearings cost significantly more, and concern remains over the risk of ceramic fracture; a complication not seen with MoP bearings, which are also cheaper. Method. We electronically randomised 268 consecutive patients undergoing THA to receive either a CoC or MoP articulation. Patients aged over 72 were excluded. In all patients the prosthesis used was an uncemented ABG II (Stryker, USA), implanted by one of the two senior authors (HDA, ABM). Patients were scored preoperatively, and at annual follow-up clinics, using SF36, Visual Analogue (VAS), Merle d'Aubigné (MD) and Oxford Hip (OHS) Scores. Satisfaction levels were also documented. Results. Follow-up ranged from 4–10 years (mean 73.9 months). 56 patients died or were lost to follow-up, leaving 212 (79.1%); 102 CoC and 110 MoP respectively. There was no statistical difference in age, follow-up, pre-operative scoring, surgeon numbers of each prosthesis or sex distribution between groups. 5 CoC patients underwent revision surgery, compared with 4 MoP. Mean follow-up scores in the CoC group were: SF36 67.9, VAS 1.5, MD 16.5 and OHS 28.2, for the MoP cohort, results were: SF36 61.1, VAS 2.4, MD 16.3 and OHS 21.8. None of these were statistically significant differences, and satisfaction levels were the same between groups. Discussion. Our data suggest that, up to 10 years, both articulations give equal satisfaction, survivorship and functional outcomes. Anecdotally, many surgeons appear increasingly to favour ceramic bearings in THA; although longer follow-up may be needed to demonstrate any advantages of ceramic over MoP, results such as ours should perhaps be considered when making this decision

Increasing knee flexion following total knee arthroplasty (TKA) has become an important outcome measure. Surgical technique is one factor that can influence knee motion. In this study, it was hypothesised that stripping of the posterior knee capsule could improve flexion and range of motion (ROM) following TKA. Patients who were undergoing TKA were prospectively randomised into two groups - one group (62 patients) were allocated stripping of the posterior knee capsule (PCS), the other group (66 patients) no stripping (no-PCS). The primary outcome was change in flexion and ROM compared to pre-operative measurements at three time points; after wound closure, 3months and 1year post-operatively. Secondary outcomes were absolute measurements of flexion, extension, ROM and complications. All operations were performed by a single surgeon using the same implant and technique. All patients received identical post-operative rehabilitation. There was a significant gain in flexion after wound closure in the PCS group (p=0.022), however there was no significant difference at 3months or 1year post-operatively. Absolute values of extension (p=0.008) and flexion (p=0.001) 3months post-operatively were significantly reduced for the PCS group. The absolute value of ROM was significantly higher for the no-PCS group at 3months (p=0.0002) and 1year (p=0.005). There were no significant difference in the rate of complications. Posterior capsular stripping causes a transient increase in flexion that does not persist post-operatively. We do not recommend routine stripping of the posterior knee capsule in patients undergoing TKA

Aims

The aim of this study was to compare the effectiveness of a femoral nerve block and a periarticular infiltration in the management of early post-operative pain after total knee arthroplasty (TKA).

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.