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

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. 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

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

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

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.

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.

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.

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.

Surgical site infections following orthopaedic surgery are a serious complication associated with increased morbidity and mortality. Intra-wound antibiotic powder may be able to provide infection prophylaxis locally with less systemic adverse effects, and promising results have been reported in systematic reviews of its use in spine surgery. This study aims to analyse the efficacy and adverse effect profile of intra-wound antibiotics in reducing surgical site infections in orthopaedic surgery for traumatic pelvic and lower limb fractures. A systematic review was conducted for studies reporting on the incidence of surgical site infections following administration of intra-wound antibiotic powder in pelvic and lower limb trauma surgery. Randomised controlled trials, cohort and case-control studies were included. A meta-analysis was conducted for deep surgical site infections. Seven studies were included in the systematic review including six retrospective case-control studies and one randomised controlled trial. Results of the meta-analysis suggest a potential 23% reduction in the odds of developing a deep surgical site infection in patients treated with intra-operative antibiotic powder compared with those managed with intravenous antibiotics alone (OR 0.77, 95% CI 0.52 – 1.13), although the results did not reach statistical significance. Notable selective bias against intra-wound antibiotics and suboptimal study design were found in the retrospective studies, however the randomised controlled trial reported a significant reduction in deep surgical site infections with intra-wound vancomycin powder. There were no reports of systemic adverse outcomes and minimal risk of wound complications with the use of intra-wound antibiotics. This review suggests the use of intra-wound antibiotic powder in pelvic and lower limb trauma surgery may reduce the incidence of deep surgical site infections. Further powered studies including randomised controlled trials are required to confirm the results highlighted in this study

Abstract. Introduction. Knee arthrodesis is one of the treatment options for limb salvage of a failed total knee replacement (TKR) when further revisions were contraindicated. The aim of this study is to determine patient outcomes after knee arthrodesis (KA) following a failed TKR. Methodology. A literature search was conducted for studies published from January 2000 through January 2022 via Medline, Web of Science, Embase and Cochrane databases. Only primary research studies were included with independent extraction of articles by two reviewers. Results were synthesised by narrative review according to PRISMA guidelines, with full tabulation of all included study results. Results. A total of 34 studies with 1,034 patients were included in the review; all were longitudinal observational studies, and none were conducted as randomised controlled trials. Reporting methods were very inconsistent in the included studies, and this heterogeneity led to pooled data totals that varied widely in different categories. The mean follow-up was 3.5 years. Overall, 72.0% (167 of 232) of patients used a walking stick and 12.5% (36 of 287) remained non-ambulatory after KA. Only 7.7% (58 of 752) of patients subsequently underwent above-knee amputation. Conclusion. KA is a potential limb salvage procedure after revision arthroplasties have been attempted in cases of failed TKR. Most patients were able to ambulate both at home and in the community, although with an increased rate of using a walking stick after the operation. However, in the absence of randomised controlled trials, these data may allow for a more accurate counselling and decision making

Introduction and Objective. Postoperative management regimes vary following open reduction and internal fixation of unstable ankle fractures. There is an evolving understanding that poorer outcomes could be associated with non-weight bearing protocols and immobilisation. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The aim of this systematic review and meta-analysis is to compare the complication rate and functional outcomes of early weight-bearing (EWB) versus late weight-bearing (LWB) following open reduction and internal fixation of ankle fractures. Materials and Methods. We performed a systematic review with a meta-analysis of controlled trials and comparative cohort studies. MEDLINE (via PubMed), Embase and the Cochrane Library electronic databases were searched inclusive of all date up to the search time. We included all studies that investigated the effect of weight-bearing following adults ankle fracture fixation by any means. All ankle fracture types, including isolated lateral malleolus fractures, isolated medial malleolus fractures, bi-malleolar fractures, tri-malleolar fractures and Syndesmosis injuries, were included. All weight-bearing protocols were considered in this review, i.e. immediate weight-bearing (IMW) within 24 hours of surgery, early weight-bearing (EWB) within three weeks of surgery, non-weight-bearing for 4 to 6 weeks from the surgery date (or late weight-bearing LWB). Studies that investigated mobilisation but not weight-bearing, non-English language publications and tibial Plafond fractures were excluded from this systematic review. We assessed the risk of bias using ROB 2 tools for randomised controlled trials and ROBINS-1 for cohort studies. Data extraction was performed using Covidence online software and meta-analysis by using RevMan 5.3. Results. After full-text review, fourteen studies (871 patients with a mean age ranged from 35 to 57 years) were deemed eligible for this systematic review; ten randomised controlled trials and four comparative cohort studies. Most of the included studies were rated as having some concern with regard to the risk of bias. There is no important difference in the infection rate between protected EWB and LWB groups (696 patients in 12 studies). The risk ratio (RR) is 1.30, [95% CI 0.74 to 2.30], I. 2. = 0%, P = 0.36). Other complications were rare. The Olerud-Molander Ankle Score (OMAS) was the widely used patient-reported outcome measure after ankle fracture fixation among the studies. The result of the six weeks OMAS analysis (three RCTs) was markedly in favour of the early weight-bearing group (MD = 10.08 [95% CI 5.13 to 15.02], I. 2. = 0%P = <0.0001). Conclusions. The risk of postoperative complications is an essential factor when considering EWB. We found that the overall incidence of surgical site infection was 6%. When comparing the two groups, the incidence was 5.2% and 6.8% for the LWB and EWB groups. This difference is not clinically important. On the other hand, significantly better early functional outcome scores were detected in the EWB group. These results are not without limitations. Protected early weight-bearing following open reduction and internal fixation of ankle fractures is potentially safe and improve short-term functional outcome. Further good-quality randomised controlled trials would be needed before we could draw a more precise conclusion

Tranexamic Acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomised control trial aimed to assess if an additional 24 hours of TXA post – operatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date this trial included high risk patients. This paper presents the results of a cost analysis undertaken alongside this RTC. TRAC-24 was a prospective randomised controlled trial on patients undergoing TKA and THA. Three groups were included, Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour post-operative oral regime, group 2 received only the perioperative dose and group 3 did not receive TXA. Cost analysis was performed out to day 90. Group 1 was associated with the lowest mean total costs, followed by group 2 and then group 3. The difference between groups 1 and 3 −£797.77 (95% CI −1478.22, −117.32) were statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in groups 1 and 2 resulted from reduced length of stay, readmission rates, Accident and Emergency (A&E) attendances and blood transfusions. This study demonstrated significant cost savings when using TXA in primary THA or TKA. Extended oral dosing reduced costs further in THA but not TKA