SummaryBackgroundFemoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery, including reshaping the hip, or with physiotherapist-led conservative care. We aimed to compare the clinical effectiveness of hip arthroscopy with best conservative care.MethodsUK FASHIoN is a pragmatic, multicentre, assessor-blinded randomised controlled trial, done at 23 National Health Service hospitals in the UK. We enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals. Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis, and were believed to be likely to benefit from hip arthroscopy. Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip was randomly assigned to treatment and followed-up. Participants were randomly allocated (1:1) to receive hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre and was done by research staff at each hospital, using a central telephone randomisation service. Patients and treating clinicians were not masked to treatment allocation, but researchers who collected the outcome assessments and analysed the results were masked. The primary outcome was hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed in all eligible participants who were allocated to treatment (the intention-to-treat population). This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN64081839, and is closed to recruitment.FindingsBetween July 20, 2012, and July 15, 2016, we identified 648 eligible patients and recruited 348 participants: 171 participants were allocated to receive hip arthroscopy and 177 to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (319 of 348 participants). At 12 months after randomisation, mean iHOT-33 scores had improved from 39·2 (SD 20·9) to 58·8 (27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group. In the primary analysis, the mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre, was 6·8 (95% CI 1·7–12·0) in favour of hip arthroscopy (p=0·0093). This estimate of treatment effect exceeded the minimum clinically important difference (6·1 points). There were 147 patient-reported adverse events (in 100 [72%] of 138 patients) in the hip arthroscopy group) versus 102 events (in 88 [60%] of 146 patients) in the personalised hip therapy group, with muscle soreness being the most common of the...

ObjectiveThe objective of this qualitative research study is to explore patient experiences of ankle fracture and the factors most important to them in recovery.DesignSemistructured interviews exploring patient experiences of ankle fracture recovery at 16–23 weeks following injury. Interviews followed a topic guide and were recorded with an encrypted audio recorder and then transcribed verbatim. Thematic content analysis was used to identify themes in the data.SettingIndividuals were recruited from a sample of participants of a UK-based clinical trial of immobilisation methods for ankle fracture (ISRCTN15537280 at the pre-results stage at time of writing). Interviews were conducted at the participants’ own homes or on a university campus setting.ParticipantsA purposive sample was used to account for key variables of age, gender and fracture management. Participants recruited from the clinical trial sample were adults aged 18 years or over with a closed ankle fracture.ResultsTen participants were interviewed, five of whom were female and six of whom needed an operation to fix their ankle fracture. The age range of participants was 21–75 years with a mean of 51.6 years. Eight themes emerged from the data during analysis; mobility, loss of independence, healthcare, psychological effects, social and family life, ankle symptoms, sleep disturbance and fatigue, and activities of daily living. Factors of importance to participants included regaining their independence, sleep quality and quantity, ability to drive, ability to walk without walking aids or weight-bearing restrictions, and radiological union.ConclusionsThe results of this research demonstrates the extensive impact of ankle fracture on individuals’ lives, including social and family life, sleep, their sense of independence and psychological well-being. The results of this study will enable an increased understanding of the factors of relevance to individuals with ankle fracture, allowing collection of appropriate outcomes in clinical studies for this condition. Ultimately these results will help formulate appropriate patient-centred rehabilitation plans for these patients.Trial registration numberISRCTN15537280; Pre-results

Objectives To assess function, quality of life, resource use, and complications in adults treated with plaster cast immobilisation versus a removable brace for ankle fracture. Design Multicentre randomised controlled trial. Setting 20 trauma units in the UK National Health Service. Participants 669 adults aged 18 years and older with an acute ankle fracture suitable for cast immobilisation: 334 were randomised to a plaster cast and 335 to a removable brace. Interventions A below the knee cast was applied and ankle range of movement exercises started on cast removal. The removable brace was fitted, and ankle range of movement exercises were started immediately. Main outcome measures Primary outcome was the Olerud Molander ankle score at 16 weeks, analysed by intention to treat. Secondary outcomes were Manchester-Oxford foot questionnaire, disability rating index, quality of life, and complications at 6, 10, and 16 weeks. Results The mean age of participants was 46 years (SD 17 years) and 381 (57%) were women. 502 (75%) participants completed the study. No statistically significant difference was found in the Olerud Molander ankle score between the cast and removable brace groups at 16 weeks (favours brace: 1.8, 95% confidence interval −2.0 to 5.6). No clinically significant differences were found in the Olerud Molander ankle scores at other time points, in the secondary unadjusted, imputed, or per protocol analyses. Conclusions Traditional plaster casting was not found to be superior to functional bracing in adults with an ankle fracture. No statistically difference was found in the Olerud Molander ankle score between the trial arms at 16 weeks. Trial registration ISRCTN registry ISRCTN15537280 .

IntroductionEach year in the UK over 120 000 people fracture their ankle. It is not known what the best rehabilitation strategy is for these people. Traditionally standard care has involved immobilisation in a plaster cast but an alternative is a functional brace, which can be removed to allow early movement. This paper details the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with an ankle fracture.Methods and analysisWe will recruit adults with a fractured ankle, for which the treating clinician would consider plaster cast to be a reasonable management option. Randomisation will be on a 1:1 basis, stratified by centre, operative or non-operative management and age. Participants will be allocated to either plaster cast or a functional brace, both treatments are widely used. To have 90% power to detect a difference of 10 points on the primary outcome (Olerud and Molander Ankle Score) at the primary outcome time point (16 weeks), we need to randomise a minimum of 478 people. Quality of life and resource use will be collected at 6, 10, 16, 24 weeks and 12, 18, 24 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The economic evaluation will adhere to the recommendations of the National Institute for Health and Care Excellence reference case.Ethics, registration and disseminationNational Research Ethic Committee approved this study on 4 July 2017 (17/WM/0239). The first site opened to recruitment 9 October 2017. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice.Trial registration number ISRCTN15537280; Pre-results.

Objectives The aim of this study is to evaluate the measurement properties of the Olerud Molander Ankle Score in adults with an ankle fracture. Methods Patients completed outcome measure questionnaires at baseline, six, 10-and 16-weeks postinjury as part of an ongoing clinical trial on ankle fracture rehabilitation. The internal consistency, convergent validity, structural validity and interpretability of the Olerud Molander Ankle Score was assessed. This was achieved through using the respective analysis methods of Cronbach's alpha, correlation coefficients, principal component analysis, evaluation of floor and ceiling scores and estimation of the minimally important change using anchor-based methods. Results The Olerud Molander Ankle Score showed adequate convergent validity against hypotheses set in relation to scores of comparator instruments. Principal component analysis demonstrated that the measure has two subscales: ankle function and ankle symptoms. The internal consistency of the measure and the ankle function subscale was sufficient, but inconclusive for the ankle symptoms subscale. There were no floor and ceiling effects present within the scores and the estimated minimally important change was 9.7 points. ConclusionThe Olerud Molander Ankle Score demonstrates sufficient measurement properties and is likely to be primarily measuring the construct of patient reported function following ankle fracture. Further research should evaluate the relevance of other domains to individuals recovering from and ankle fracture, such as social participation and psychological wellbeing. The development of a core outcome set would be advantageous to standardise outcome measurement collection in this area.

BackgroundAnkle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology.MethodsWe searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles.ResultsThe searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity.ConclusionsThere is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.

Background Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture. Methods We performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type. Results The searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980’s. Conclusion This review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results. Electronic supplementary material The online version of this article (10.1186/s12891-019-2770-2) contains supplementary material, which is available to authorized users.

Background Approximately 9% of a trauma surgeon’s workload in the UK is managing ankle fractures. Following an ankle fracture immobilisation with a plaster cast or removable orthotic is usual. The aim of this research was to assess the feasibility of a large multi-centre randomised controlled trial (RCT) to evaluate the difference between plaster cast and a removable orthotic for the management of adults with an ankle fracture. Methods A feasibility randomised controlled trial was undertaken in a UK trauma hospital in adults with an ankle fracture for which the treating clinician would consider plaster cast a reasonable management option. Exclusions included open or pathological fracture, unable to adhere to trial procedures, had other lower limb injury or required close contact casting. Participants were randomised using an independent telephone service to receive either plaster cast or removable orthotic. The primary outcome was to determine the recruitment and follow-up rates at 6 weeks, 3 and 6 months to assess the feasibility of a full RCT. Results Eighty five eligible patients presented during the 10-month recruitment period, 50 consented. Two patients were randomised who did not fulfil the eligibility criteria (protocol deviations), and 1 patient from each group crossed over. Follow-up at each time point was 92% at 6 weeks; 74% at 3 months and 83% at 6 months. Conclusions Recruitment and follow-up data demonstrated feasibility of conducting a larger-scale randomised controlled trial. The distributional properties of the patient-reported outcome measures will be used to determine future sample sizes. Trial registrations This study is registered with the ISRCTN ( ISRCTN17809322 ), assigned 5 November 2015 and approved by the NRES Committee (The Black Country, 15/WM/0340), protocol version 2.0 (17 November 2015). It is co-sponsored by the University Hospitals Coventry and Warwickshire NHS Trust and University of Warwick and funded by the NIHR Research for Patient Benefit (PB-PG-0614-34,009). The trial sponsors have no direct involvement in any aspects of study design, conduct or decision to submit the report for publication.