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Aims The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence. Methods Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function. Results Previously described measures of RM and surgeon opinion of clinically significant malunion (CSM) were shown to be related but with important differences. CSM was more strongly related to outcome (-13.9 points on the OMAS; 95% confidence interval (CI) -21.9 to -5.4) than RM (-5.5 points; 95% CI -9.8 to -1.2). Existing malunion thresholds for talar tilt and tibiofibular clear space were shown to be slightly conservative; new thresholds which better explain function were identified (talar tilt > 2.4°; tibiofibular clear space > 6 mm). Based on this new definition the presence of RM had an impact on function, which was statistically significant, but the clinical significance was uncertain (-9.1 points; 95% CI -13.8 to -4.4). In subsequent analysis, RM of a posterior malleolar fracture was shown to have a statistically significant impact on OMAS change scores, but the clinical significance was uncertain (-11.6 points; 95% CI -21.9 to -0.6). Conclusion These results provide clinical evidence which supports the previously accepted definitions. Further research to investigate more conservative clinical thresholds for malunion is indicated. Cite this article: Bone Jt Open 2022;3(10):841–849.

AimsTo systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery.MethodsWe undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes.ResultsFrom 2,682 records, 15 studies were reviewed in full and four included in the review. A total of 72 patients were included across the four studies (47 female; mean age 50 years (17 to 80)). Methodological quality was high for all studies, and the GRADE-CERQual checklist provided confidence that the findings were an adequate representation of patient experience of distal tibia or ankle fracture. A central concept of ‘being the same but different’ conveyed the substantial disruption to patients’ self-identity caused by their injury. Patient experience of ‘being the same but different’ was expressed through three interrelated themes, with seven subthemes: i) being proactive where persistence, doing things differently and keeping busy prevailed; ii) living with change including symptoms, and living differently due to challenges at work and leisure; and iii) striving for normality, adapting while lacking in confidence, and feeling fearful and concerned about the future.ConclusionAnkle injuries were disruptive, draining, and impacted on patients’ wellbeing. Substantial short- and longer-term challenges were experienced during recovery. Rehabilitation and psychosocial treatment strategies may help to ameliorate these challenges. Patients may benefit from clinicians being cognisant of patient experience when assessing, treating, and discussing expectations and outcomes with patients.Cite this article: Bone Jt Open 2023;4(3):188–197.

The close bidirectional relationship between the microbiome and the immune system is well supported, and a role of gut dysbiosis has been implied in many systemic autoimmune diseases. This review aims to provide a critical summary and appraisal of 6 murine studies and 16 clinical studies. The findings of the literature review suggest that gut dysbiosis precedes arthritis and that local intestinal inflammation leads to systemic inflammation in genetically predisposed individuals. However, the exact mechanism by which microorganisms provoke immune responses at distal sites remains to be elucidated. Although a characteristic RA microbiome was not identified, there were some common findings among studies: overabundance of Prevotella copri in early RA patients, and proliferation of the genus Collinsela and some Lactobacillus species. Three mechanisms by which microbiota might contribute to RA pathogenesis were proposed: inflammatory responses (P. copri and Lactobacillus), molecular mimicry (P. copri) and loss of intestinal barrier integrity (Collinsella). Larger longitudinal studies are required in order to shed light on the mechanisms involved and unravel the therapeutic potential of the microbiome, and clinical trials are needed to evaluate the safety and efficacy of the implied therapeutic interventions.

BackgroundAnkle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials.MethodsThe study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set.DiscussionDevelopment of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

Aims To identify the prevalence of neuropathic pain after lower limb fracture surgery, assess associations with pain severity, quality of life and disability, and determine baseline predictors of chronic neuropathic pain at three and at six months post-injury. Methods Secondary analysis of a UK multicentre randomized controlled trial (Wound Healing in Surgery for Trauma; WHiST) dataset including adults aged 16 years or over following surgery for lower limb major trauma. The trial recruited 1,547 participants from 24 trauma centres. Neuropathic pain was measured at three and six months using the Doleur Neuropathique Questionnaire (DN4); 701 participants provided a DN4 score at three months and 781 at six months. Overall, 933 participants provided DN4 for at least one time point. Physical disability (Disability Rating Index (DRI) 0 to 100) and health-related quality-of-life (EuroQol five-dimension five-level; EQ-5D-5L) were measured. Candidate predictors of neuropathic pain included sex, age, BMI, injury mechanism, concurrent injury, diabetes, smoking, alcohol, analgaesia use pre-injury, index surgery location, fixation type, Injury Severity Score, open injury, and wound care. Results The median age of the participants was 51 years (interquartile range 35 to 64). At three and six months post-injury respectively, 32% (222/702) and 30% (234/787) had neuropathic pain, 56% (396/702) and 53% (413/787) had chronic pain without neuropathic characteristics, and the remainder were pain-free. Pain severity was higher among those with neuropathic pain. Linear regression analyses found that those with neuropathic pain at six months post-injury had more physical disability (DRI adjusted mean difference 11.49 (95% confidence interval (CI) 7.84 to 15.14; p < 0.001) and poorer quality of life (EQ-5D utility -0.15 (95% CI -0.19 to -0.11); p < 0.001) compared to those without neuropathic characteristics. Logistic regression identified that prognostic factors of younger age, current smoker, below knee fracture, concurrent injuries, and regular analgaesia pre-injury were associated with higher odds of post-injury neuropathic pain. Conclusion Pain with neuropathic characteristics is common after lower limb fracture surgery and persists to six months post-injury. Persistent neuropathic pain is associated with substantially poorer recovery. Further attention to identify neuropathic pain post-lower limb injury, predicting patients at risk, and targeting interventions, is indicated. Cite this article: Bone Joint J 2021;103-B(6):1047–1054.

Background/Aims Distal radius fractures (DRF) are common fall-related fragility fractures disproportionately affecting older females. After a DRF, there is an increased risk of future fragility fractures and functional decline. Systematic review evidence shows balance and muscle strengthening exercises reduce falls in older adults. Despite this, existing DRF rehabilitation trials have mainly focused on upper limb impairments. To inform rehabilitation requirements, we aimed to 1.) compare lower limb muscle strength and balance between older adults with a DRF with age- and sex-matched controls, and 2.) synthesise lower limb muscle strength and balance outcomes in older adults with a DRF. Methods We searched Embase, MEDLINE and CINAHL (1990 to August 2021). We included randomised and non-randomised controlled trials, and observational studies, that assessed lower limb strength and/or balance in adults aged ≥50 years enrolled within one year after a DRF. Strength and balance had to be assessed using validated instrumented or physical performance measures. Two reviewers independently screened titles and abstracts, and full-text reports of potentially eligible studies. One reviewer extracted data, then checked by another. Two reviewers independently appraised studies using the Cochrane risk-of-bias tool or Newcastle-Ottawa scale. We synthesised results narratively due to heterogeneity. PROSPERO registration: CRD42020196274. Results Seventeen studies (10 case-control studies, three RCTs and four case-series) including 1112 participants (95% women) with a DRF were included. Participants’ mean age ranged from 56 to 73 years; median sample size was 80 (IQR 54-106). Eleven (65%) studies assessed lower limb muscle strength using 10 different methods. Knee extensor strength assessment was most common (5/11 studies) followed by the 30-second and five times sit-to-stand tests (3/11 studies). All studies assessed balance, using 14 different methods. Single leg balance assessment was most common (6/17 studies) followed by functional reach and postural sway (3/17 studies). 5/10 case-control studies assessed lower limb muscle strength. Two studies found cases performed worse than controls during sit-to-stand tests; three studies assessed knee extensor strength with conflicting findings. All case-control studies assessed balance, with cases demonstrating impaired balance compared to controls on some measures. 4/17 studies assessed strength and 6/17 studies assessed balance at multiple timepoints. Over time, strength progressively improved in 3/4 studies but changes in balance were inconsistent across studies. Conclusion There is some evidence that older adults with a DRF have impaired lower limb muscle strength and balance compared to age- and sex-matched controls, but findings are inconsistent. Synthesis of results was limited by heterogeneity in the design, quality, and assessment methods used in included studies. Large-scale robust case-control and/or prospective observational studies are needed to better establish the rehabilitation requirements for this population. Disclosure C. Forde: Grants/research support; CF is supported by the NIHR Biomedical Research Centre, based at Oxford University Hospitals Trust, Oxford. P.J.A. Nicolson: Grants/research support; PN is supported by a Versus Arthritis Foundation Fellowship (ref. 22428). C. Vye: None. J.C.H. Pun: Grants/research support; JP received financial support from the NMAHPs Internship Versus Arthritis (Grant reference 22082). W. Sheehan: None. M. Costa: Grants/research support; MC receives grants from NIHR and related health charities. S.E. Lamb: Grants/research support; SL receives grants from NIHR and related health charities. D.J. Keene: Grants/research support; DK is supported by a National Institute of Health Research (NIHR) Postdoctoral Fellowship (ref. PDF-2016-09-056) and by the NIHR Biomedical Research Centre, based at Oxford University Hospitals Trust.

Objective To estimate the generalizability of treatment effects observed in a randomized trial of hip fracture surgery implants to a broader population of people undergoing hip surgery in the United Kingdom. Study Design and Setting In 2018, the WHiTE-3 trial (n = 958) demonstrated that a modular hemiarthroplasty implant conferred no additional benefit over the traditional monoblock implant for quality of life and length of hospital stay. We compared and weighted the trial sample against two target populations: WHiTE-cohort (n = 2,457) and UK-National Hip Fracture Database (NHFD, n = 190,894), and re-estimate expected treatment effects for the target populations. Results Despite differences in baseline characteristics of the trial sample and target populations, the re-estimated treatment effects were comparable. For quality of life, the differences between the trial estimate and WHiTE-cohort and NHFD estimates were 0.01 points on the EuroQol (EQ5D). For length of stay, the difference between the trial estimate and WHiTE-cohort was 0.50 days; and the difference between the trial estimate and NHFD estimate was −0.47 days. Conclusion This generalizability analysis of the WHiTE-3 trial found that the inferences from the trial can be generalized to a wider population of individuals in the UK NHFD and the WHiTE-cohort who met the inclusion criteria for WHiTE-3.

Corrections to Table 15.

Background The Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. This article describes the statistical analysis plan for the GRASP randomised controlled trial. Methods/design GRASP is a multicentre randomised controlled trial using a 2 × 2 factorial design. Adults aged ≥ 18 years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery, are randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection then best practice advice. The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score over 12 months. Secondary outcomes are as follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability. Here, we describe in detail the following: sample size calculation, descriptive statistics of the primary and secondary outcomes, statistical models used for the analysis of the main outcomes, handling of missing data, planned sensitivity and subgroup analyses. This pre-specified statistical analysis plan was written and submitted without prior knowledge of the trial results. Discussion Publication of the statistical analysis plan for the GRASP trial aims to reduce the risk of outcome reporting bias and increase transparency of the data analysis. Any deviations or changes to the current SAP will be described and justified in the final study report and any results publications. Trial registration International Standard Randomised Controlled Trial Number ISRCTN16539266. Registered on 14 June 2016. EudraCT number 2016-002991-28. Registered on 12 June 2016.

Objectives The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2 × 2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions. Methods Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service. Results Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. Conclusion GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020.

Background Distal radius fractures represent about 1 in 5 of all fractures treated in UK hospitals. Most distal radius fractures occur in women aged 50 years or over after a fall. Distal radius fractures are managed using splints or casting, some are also treated with surgical fixation. Patients often experience long-term muscle weakness of the hand and arm that may impact their ability to do daily activities such as personal hygiene, routine household chores and food preparation. We propose a structured and tailored flexibility and resistance exercise programme for the hand and arm supplemented with behaviour change strategies to help perform daily exercise. The main aim of our study is to assess the feasibility of conducting a definitive randomised controlled trial. Methods This study is a multicentre, parallel-group individually randomised feasibility trial. We will recruit a minimum of 72 adults aged 50 years or over with distal radius fracture treated surgically or non-surgically from at least three UK National Health Service (NHS) hospitals. They will be randomised 1:1:1 to receive usual care, usual care and independent exercise with a single therapy session or usual care and supervised exercise with three therapy sessions over 12 weeks. Our primary feasibility objectives are (1) patient engagement assessed by recruitment, (2) acceptability of the interventions assessed by adherence and patient and clinician experience and (3) retention of participants in the trial. Outcome measures will be assessed at baseline, 3 months and at 6 months after randomisation. A qualitative sub-study will explore the experiences of the trial participants and therapists delivering the exercises. Discussion A definitive trial will be considered feasible without major modifications if our progression criteria are met. If successful, the findings will inform the design of a future definitive RCT to evaluate the clinical and cost-effectiveness of the WISE exercise programme. Trial registration ISRCTN12290145.

Background Lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants’ activity-related goals, has rationale, but has not been previously reported. In line with the Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment. Methods A single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over a maximum of 3 months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics. Results Fifteen of 22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. Two of 15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they ‘always’ or ‘often’ completed the prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions. Conclusion The intervention appeared acceptable to adults after acute lateral patellar dislocation, and a future randomised pilot trial is feasible. This future pilot trial should estimate attrition with increased precision over a longer duration and assess participants’ willingness to be randomised to different treatments across multiple centres. Trial registration ClinicalTrials.govNCT03798483, registered on January 10, 2019

Background Rotator cuff-related shoulder pain is very common, but there is uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits of corticosteroid injections. Objectives To assess the clinical effectiveness and cost-effectiveness of progressive exercise compared with best-practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. Design This was a pragmatic multicentre superiority randomised controlled trial (with a 2 × 2 factorial design). Setting Twenty NHS primary care-based musculoskeletal and related physiotherapy services. Participants Adults aged ≥ 18 years with a new episode of rotator cuff-related shoulder pain in the previous 6 months. Interventions A total of 708 participants were randomised (March 2017–May 2019) by a centralised computer-generated 1 : 1 : 1 : 1 allocation ratio to one of four interventions: (1) progressive exercise (n = 174) (six or fewer physiotherapy sessions), (2) best-practice advice (n = 174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise (n = 182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice (n = 178) (one physiotherapy session). Main outcome measures The primary outcome was Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes included SPADI subdomains, the EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, pain self-efficacy, return to activity, Global Impression of Treatment and health resource use. Outcomes were collected by postal questionnaires at 8 weeks and at 6 and 12 months. A within-trial economic evaluation was also conducted. The primary analysis was intention to treat. Results Participants had a mean age of 55.5 (standard deviation 13.1) years and 49.3% were female. The mean baseline SPADI score was 54.1 (standard deviation 18.5). Follow-up rates were 91% at 8 weeks and 87% at 6 and 12 months. There was an overall improvement in SPADI score from baseline in each group over time. Over 12 months, there was no evidence of a difference in the SPADI scores between the progressive exercise intervention and the best-practice advice intervention in shoulder pain and function (adjusted mean difference between groups over 12 months –0.66, 99% confidence interval –4.52 to 3.20). There was also no difference in SPADI scores between the progressive exercise intervention and best-practice advice intervention when analysed at the 8-week and 6- and 12-month time points. Injection resulted in improvement in shoulder pain and function at 8 weeks compared with no injection (adjusted mean difference –5.64, 99% confidence interval –9.93 to –1.35), but not when analysed over 12 months (adjusted mean difference –1.11, 99% confidence interval –4.47 to 2.26), or at 6 and 12 months. There were no serious adverse events. In the base-case analysis, adding injection to best-practice advice gained 0.021 quality-adjusted life-years (p = 0.184) and increased the cost by £10 per participant (p = 0.747). Progressive exercise alone was £52 (p = 0.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs (p = 0.220). At a ceiling ratio of £20,000 per quality-adjusted life-year, injection plus best-practice advice had a 54.93% probability of being the most cost-effective treatment. Limitations Participants and physiotherapists were not blinded to group allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns. Conclusions Progressive exercise was not superior to a best-practice advice session with a physiotherapist. Subacromial corticosteroid injection improved shoulder pain and function, but provided only modest short-term benefit. Best-practice advice in combination with corticosteroid injection was expected to be most cost-effective, although there was substantial uncertainty. Future work Longer-term follow-up, including any serious adverse effects of corticosteroid injection. Trial registration Current Controlled Trials ISRCTN16539266 and EudraCT 2016-002991-28. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.

Background Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. Methods In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28. Findings Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference −0·66 [99% CI −4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (−1·11 [–4·47 to 2·26]). No serious adverse events were reported. Interpretation Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders. Funding UK National Institute for Health Research Technology Assessment Programme.

Objective Synthesize evidence on objectively quantified lower limb strength recovery in people treated surgically or non-surgically after patellar dislocation. Methods MEDLINE, EMBASE, Cochrane Library, SPORTDiscus, PEDro, AMED and CINAHL databases were last searched on July 30th, 2020 for randomized controlled trials and observational studies that objectively quantified lower limb strength in people (any age or sex) treated surgically or non-surgically after patellar dislocation. Results 24 studies were included (877 participants, median age 20.7). All assessed knee extension strength, 11 knee flexion strength, three hip abduction strength, two hip external rotation strength, and one hip flexion, extension, adduction, and internal rotation strength. One randomized controlled trial judged at high risk of bias and two cohort studies with methodological limitations compared lower limb strength recovery between surgically and non-surgically treated people, with conflicting findings. After surgery, median long-term (>8 months) knee extension strength was 82.5% (IQR 78.5–88.2; 13 studies) of the unaffected leg and knee flexion strength was 91.5% (IQR 90.7–96.9; five studies). After non-surgical treatment, median long-term knee extension strength was 86% (IQR 79.3–87.4; four studies) and mean flexion strength ranged from 95.2 to 96.7% (two studies). Mean hip strength was always >90% (two studies). Two redislocations during eccentric isokinetic knee testing and knee pain during isokinetic knee extension testing were reported as adverse events. Conclusions Available evidence indicates that after patellar dislocation, knee extension strength deficits in the affected limb are frequently observed and can persist long term, but this remains uncertain due to the limitations of relevant included studies. Whether lower limb strength recovery differs between people treated surgically and those treated non-surgically after patellar dislocation also remains uncertain. Trial registration (PROSPERO CRD42019139533)

Background To aid design of exercise trials for people with pelvic and lower limb fragility fractures a systematic review was conducted to identify what types of exercise interventions and mobility outcomes have been assessed, investigate intervention reporting quality, and evaluate risk of bias in published trials. Methods Systematic searches of electronic databases (CENTRAL, MEDLINE, EMBASE, PEDro) 1996–2019 were conducted to identify randomised controlled trials of exercise for pelvic or lower limb fragility fractures. Two reviewers independently screened titles and abstracts. One reviewer extracted data, a second verified. Two reviewers independently assessed risk of bias. Intervention reporting quality was based on TIDieR, assessed by one reviewer and verified by a second. Narrative synthesis was undertaken. Registration: PROSPERO CRD42017060905. Results Searches identified 37 trials including 3564 participants, median sample size 81 (IQR 48–124), participants aged 81 years (IQR 79–82) and 76% (2536/3356) female. All trials focussed on people with hip fracture except one on ankle fracture. Exercise types focussed on resistance exercise in 14 trials, weight bearing exercise in 5 trials, 13 varied dose of sessions with health professionals, and 2 trials each focussed on treadmill gait training, timing of weight bearing or aerobic exercise. 30/37 (81%) of trials reported adequate sequence generation, 25/37 (68%) sufficient allocation concealment. 10/37 (27%) trials lacked outcome assessor blinding. Of 65 exercise interventions, reporting was clear for 33 (51%) in terms of when started, 61 (94%) for where delivered, 49 (75%) for who delivered, 47 (72%) for group or individual, 29 (45%) for duration, 46 (71%) for session frequency, 8 (12%) for full prescription details to enable the exercises to be reproduced, 32 (49%) clearly reported tailoring or modification, and 23 (35%) reported exercise adherence. Subjectively assessed mobility was assessed in 22/37 (59%) studies and 29/37 (78%) used an objective measure. Conclusions All trials focussed on hip fracture, apart from one ankle fracture trial. Research into pelvic and other lower limb fragility fractures is indicated. A range of exercise types were investigated but to date deficiencies in intervention reporting hamper reproducibility. Adoption of TIDieR and CERT guidelines should improve intervention reporting as use increases. Trials would be improved by consistent blinded outcome assessor use and with consensus on which mobility outcomes should be assessed.

The Ankle Injury Management (AIM) trial was a pragmatic equivalence randomized controlled trial conducted at 24 hospitals in the United Kingdom that recruited 620 patients aged more than 60 years with an unstable ankle fracture. The trial compared the usual care pathway of early management with open reduction and internal fixation with initially attempting non-surgical management using close contact casting (CCC). CCC is a minimally padded cast applied by an orthopaedic surgeon after closed reduction in the operating theatre. The intervention groups had equivalent functional outcomes at six months and longer-term follow-up. However, potential barriers to using CCC as an initial form of treatment for these patients have been identified. In this report, the results of the AIM trial are summarized and the key issues are discussed in order to further the debate about the role of CCC. Evidence from the AIM trial supports surgeons considering conservative management by CCC as a treatment option for these patients. The longer-term follow-up emphasized that patients treated with CCC need careful monitoring in the weeks after its application to monitor maintenance of reduction. Cite this article: Bone Joint J 2019;101-B:1472–1475.

IntroductionAnkle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.Methods and analysisA multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.Ethics and disseminationHampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.Trial registration numberISRCTN16612336

We highlight the important differences between the concepts of capacity and performance and highlight the development of measures and their application in common conditions encountered in health care practice with older people. A number of expert consensus projects have concluded that mobility, balance, muscle strength and dexterity are core domains for capacity measurement in older people. Instruments with evidence of adequate psychometric properties for the evaluation of capacity in response to intervention programmes include the Short Physical Performance Battery, hand grip strength, mini-BEST and 9-hole pegboard test. Measures that can track individual change and convey information that can be used to inform clinical decision-making, individual prognosis or prediction of events require greater precision. However, few such measures are available. Performance measurement usually focuses on basic or instrumental (advanced) Activities of Daily Living performed by people in their usual environments. Finally, we discuss the limitations of physical performance and capacity measures and future developments that may enhance the use of these measures in health and clinical care.

ObjectiveTo predict functional outcomes 6 months after ankle fracture in people aged ≥60 years using post-treatment and 6-week follow-up data to inform anticipated recovery, and identify people who may benefit from additional monitoring or rehabilitation.DesignPrognostic model development and internal validation.Setting24 National Health Service hospitals, UK.MethodsParticipants were the Ankle Injury Management clinical trial cohort (n=618) (ISRCTN04180738), aged 60–96 years, 459/618 (74%) female, treated surgically or conservatively for unstable ankle fracture. Predictors were injury and sociodemographic variables collected at baseline (acute hospital setting) and 6-week follow-up (clinic). Outcome measures were 6-month postinjury (primary) self-reported ankle function, using the Olerud and Molander Ankle Score (OMAS), and (secondary) Timed Up and Go (TUG) test by blinded assessor. Missing data were managed with single imputation. Multivariable linear regression models were built to predict OMAS or TUG, using baseline variables or baseline and 6-week follow-up variables. Models were internally validated using bootstrapping.ResultsThe OMAS baseline data model included: alcohol per week (units), postinjury EQ-5D-3L visual analogue scale (VAS), sex, preinjury walking distance and walking aid use, smoking status and perceived health status. The baseline/6-week data model included the same baseline variables, minus EQ-5D-3L VAS, plus five 6-week predictors: radiological malalignment, injured ankle dorsiflexion and plantarflexion range of motion, and 6-week OMAS and EQ-5D-3L. The models explained approximately 23% and 26% of the outcome variation, respectively. Similar baseline and baseline/6 week data models to predict TUG explained around 30% and 32% of the outcome variation, respectively.ConclusionsPredictive accuracy of the prognostic models using commonly recorded clinical data to predict self-reported or objectively measured ankle function was relatively low and therefore unlikely to be beneficial for clinical practice and counselling of patients. Other potential predictors (eg, psychological factors such as catastrophising and fear avoidance) should be investigated to improve predictive accuracy.Trial registration numberISRCTN04180738; Post-results.

BackgroundAnkle sprains are very common injuries. Although recovery can occur within weeks, around one-third of patients have longer-term problems.ObjectivesTo develop and externally validate a prognostic model for identifying people at increased risk of poor outcome after an acute ankle sprain.DesignDevelopment of a prognostic model in a clinical trial cohort data set and external validation in a prospective cohort study.SettingEmergency departments (EDs) in the UK.ParticipantsAdults with an acute ankle sprain (within 7 days of injury).Sample sizeThere were 584 clinical trial participants in the development data set and 682 recruited for the external validation study.PredictorsCandidate predictor variables were chosen based on availability in the clinical data set, clinical consensus, face validity, a systematic review of the literature, data quality and plausibility of predictiveness of the outcomes.Main outcome measuresModels were developed to predict two composite outcomes representing poor outcome. Outcome 1 was the presence of at least one of the following symptoms at 9 months after injury: persistent pain, functional difficulty or lack of confidence. Outcome 2 included the same symptoms as outcome 1, with the addition of recurrence of injury. Rates of poor outcome in the external data set were lower than in the development data set, 7% versus 20% for outcome 1 and 16% versus 24% for outcome 2.AnalysisMultiple imputation was used to handle missing data. Logistic regression models, together with multivariable fractional polynomials, were used to select variables and identify transformations of continuous predictors that best predicted the outcome based on a nominal alpha of 0.157, chosen to minimise overfitting. Predictive accuracy was evaluated by assessing model discrimination (c-statistic) and calibration (flexible calibration plot).Results(1) Performance of the prognostic models in development data set – the combinedc-statistic for the outcome 1 model across the 50 imputed data sets was 0.74 [95% confidence interval (CI) 0.70 to 0.79], with good model calibration across the imputed data sets. The combinedc-statistic for the outcome 2 model across the 50 imputed data sets was 0.70 (95% CI 0.65 to 0.74), with good model calibration across the imputed data sets. Updating these models, which used baseline data collected at the ED, with an additional variable at 4 weeks post injury (pain when bearing weight on the ankle) improved the discriminatory ability (c-statistic 0.77, 95% CI 0.73 to 0.82, for outcome 1 and 0.75, 95% CI 0.71 to 0.80, for outcome 2) and calibration of both models. (2) Performance of the models in the external data set – the combinedc-statistic for the outcome 1 model across the 50 imputed data sets was 0.73 (95% CI 0.66 to 0.79), with a calibration plot intercept of –0.91 (95% CI –0.98 to 0.44) and slope of 1.13 (95% CI 0.76 to 1.50). The combinedc-statistic for the outcome 2 model across the 50 imputed data sets was 0.63 (95% CI 0.58 to 0.69), with a calibration plot intercept of –0.25 (95% CI –0.27 to 0.11) and slope of 1.03 (95% CI 0.65 to 1.42). The updated models with the additional pain variable at 4 weeks had improved discriminatory ability over the baseline models but not better calibration.ConclusionsThe SPRAINED (Synthesising a clinical Prognostic Rule for Ankle Injuries in the Emergency Department) prognostic models performed reasonably well, and showed benefit compared with not using any model; therefore, the models may assist clinical decision-making when managing and advising ankle sprain patients in the ED setting. The models use predictors that are simple to obtain.LimitationsThe data used were from a randomised controlled trial and so were not originally intended to fulfil the aim of developing prognostic models. However, the data set was the best available, including data on the symptoms and clinical events of interest.Future workFurther model refinement, including recalibration or identifying additional predictors, may be required. The effect of implementing and using either model in clinical practice, in terms of acceptability and uptake by clinicians and on patient outcomes, should be investigated.Trial registrationCurrent Controlled Trials ISRCTN12726986.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 64. See the NIHR Journals Library website for further project information. Funding was also recieved from the NIHR Collaboration for Leadership in Applied Health Research, Care Oxford at Oxford Health NHS Foundation Trust, NIHR Biomedical Research Centre, Oxford, and the NIHR Fellowship programme.

ObjectiveTo determine research priorities in fragility fractures of the lower limb and pelvis which represent the shared priorities of patients, their friends and families, carers and healthcare professionals.Design/settingA national (UK) research priority setting partnership.ParticipantsPatients over 60 years of age who have experienced a fragility fracture of the lower limb or pelvis; carers involved in their care (both in and out of hospital); family and friends of patients; healthcare professionals involved in the treatment of these patients including but not limited to surgeons, anaesthetists, paramedics, nurses, general practitioners, physicians, physiotherapists and occupational therapists.MethodsUsing a multiphase methodology in partnership with the James Lind Alliance over 18 months (August 2016–January 2018), a national scoping survey asked respondents to submit their research uncertainties. These were amalgamated into a smaller number of research questions. The existing evidence was searched to ensure that the questions had not been answered. A second national survey asked respondents to prioritise the research questions. A final shortlist of 25 questions was taken to a multistakeholder workshop where a consensus was reached on the top 10 priorities.ResultsThere were 963 original uncertainties submitted by 365 respondents to the first survey. These original uncertainties were refined into 88 research questions of which 76 were judged to be true uncertainties following a review of the research evidence. Healthcare professionals and other stakeholders (patients, carers, friends and families) were represented equally in the responses. The top 10 represent uncertainties in rehabilitation, pain management, anaesthesia and surgery.ConclusionsWe report the top 10 UK research priorities in patients with fragility fractures of the lower limb and pelvis. The priorities highlight uncertainties in rehabilitation, postoperative physiotherapy, pain, weight-bearing, infection and thromboprophylaxis. The challenge now is to refine and deliver answers to these research priorities.

Study Design: Randomized 3-treatment, 3-period crossover trial.Background: There is variation in clinical practice regarding the type of ankle support used to aid recovery after ankle fracture internal fixation surgery.Objective: To determine the immediate effects of different ankle supports commonly issued to patients 6 weeks after surgery.Methods: Participants were 18 adults, 6 weeks after internal fixation for transsyndesmotic/infrasyndesmotic fracture, in a major trauma center in the UK. Interventions were a stirrup brace and walker boot compared with Tubigrip. Outcomes were (1) step-length and single-limb support time asymmetry (percentage comparing injured and uninjured limbs), (2) step width, (3) gait velocity, and (4) pain during walking (visual analog scale, 0–100).Results: Participants (mean ± SD age, 47 ± 14 years) included 8 women and 10 men, 6 weeks after surgical internal fixation for ankle fracture. Single-limb support time asymmetry reduced by 3% (95% confidence interval [CI]: 0%, 6%; P = .02) in the stirrup brace and by 5% (95% CI: 2%, 7%; P = .001) in the walker boot compared with Tubigrip. Step width was 1.2 cm (95% CI: 0.6, 1.7; PConclusion: At 6 weeks after surgical internal fixation for ankle fracture, pain and single-limb support time asymmetry over a short distance and for a short-term walk were immediately reduced with the use of a walker boot use and, to a lesser extent, a stirrup-brace compared to Tubigrip. Step width also widened in a walker boot, which may confer some additional gait stability. These results apply to immediate effects, so studies with longer-term follow-up are now indicated. The trial was registered at http://www.isrctn.com/ (ISRCTN84536917).Level of Evidence: Therapy, level 2b.

Differences in gait performance can be explained by variations in walking speed, which is a major analytical problem. Some investigators have standardised speed during testing, but this can result in an unnatural control of gait characteristics. Other investigators have developed test procedures where participants walking at their self-selected slow, preferred and fast speeds, with computation of gait characteristics at a standardised speed. However, this analysis is dependent upon an overlap in the ranges of gait speed observed within and between participants, and this is difficult to achieve under self-selected conditions. In this report a statistical analysis procedure is introduced that utilises multilevel modelling to analyse data from walking tests at self-selected speeds, without requiring an overlap in the range of speeds observed or the routine use of data transformations.

A randomized clinical trial of close contact casting vs the usual practice of surgery for treating unstable ankle fractures in older adults found equivalent ankle function outcomes at 6 months.1 Higher rates of radiological ankle malunion in the casting vs surgical groups (15% vs 3%, respectively) and nonunion (medial malleolus: 7% vs 1%, respectively) suggested that equivalence between the 2 groups may be lost if symptoms or functional limitations from posttraumatic arthritis manifest later.2 A follow-up at least 3 years after randomization was conducted to determine if equivalence persisted over time.\ud \ud Methods:\ud This study was a prespecified extended follow-up of a pragmatic, multicenter, equivalence randomized clinical trial.1 The National Research Ethics Service, Oxfordshire, gave approval; written informed consent was obtained. Participants were adults older than 60 years with acute unstable malleolar fracture(s) from 24 UK centers. Participants had received surgery (usual local practice internal fixation) or close contact casting, in which a minimally padded cast was applied after closed fracture reduction by an orthopedic surgeon in an operating room under anesthesia. Data were collected for at least 3 years after randomization using patient-reported postal questionnaires.\ud \ud The primary outcome measure for the original trial was the Olerud and Molander Ankle Score (OMAS; range, 0-100, higher scores = better ankle function) at 6 months,3 with a prespecified equivalence margin of ±6 points. Extended follow-up used the same primary outcome and equivalence margin and assessed quality of life and pain as secondary outcomes (Table 1). A post hoc analysis of additional operations after 6 months was also conducted. Per-protocol primary analysis was used, consistent with the main trial.1 Random-effects models estimated mean differences and 95% CIs between treatments adjusted for age, sex, fracture pattern, baseline score, and time to follow-up, including the center variable as a random effect. The random-effects model was also used post hoc to assess differences in OMAS for participants with vs without radiological malunion and nonunion at 6 months. Change from baseline score was analyzed for outcomes without normal distribution. The primary outcome at extended follow-up assessed equivalence with the null hypothesis that the 2 groups were not equivalent. For all other outcomes, tests were 2-sided with a P value of .05 or less for significance. Analyses were conducted with Stata (StataCorp), version 15.0.\ud \ud Results:\ud From September 2013 through November 2016, 450 of the 620 randomized participants (73%) responded to follow-up at a median of 3 years (range, 2.9-9.5). Responders and nonresponders had similar characteristics (Table 1). Most responders lived in their own home (209 of 222 participants [94%] in the surgery group and 196 of 206 participants [95%] in the casting group).\ud \ud Surgery and casting participants had equivalent ankle function (mean OMAS: 79.4 in the surgery group vs 76.3 in the casting group; difference, −1.3 [95% CI, −5.6 to 3.0]) and no significant differences in quality of life or pain (Table 2). Twenty-two of 222 surgery participants (10%) and 17 of 206 casting participants (8%) had operations after 6 months, including surgical implant removals (15 in the surgery group [7%] vs 8 in the casting group [4%]), arthrodesis (1 in the surgery group [0.5%] vs 3 in the casting group [1.5%]), arthroplasty (1 in the surgery group [0.5%] and 1 in the casting group [0.5%]), and infection-related procedures (2 in the surgery group [1%] and 0 in the casting group). Five casting participants (2%) had internal fixations for nonunion after 6 months. There was 1 internal fixation revision, 1 arthroscopy, and 1 hindfoot osteotomy among surgery participants. In post hoc analysis, from randomization to extended follow-up, mean total operating room procedures per participant (per protocol) were 1.2 (SD, 0.5) in the surgery group and 1.3 (SD, 0.6) in the casting group, and mean total surgical procedures per participant were 1.2 (SD, 0.5) in the surgery group and 0.3 (SD, 0.6) in the casting group.\ud \ud Of 67 participants with radiological abnormalities at 6 months, 43 (64%) provided extended follow-up data. Those with malleolar malunion at 6 months had significantly lower OMAS scores (n = 30; mean, 58.7 [SD, 33.1]) than those without (n = 372; mean, 79.8 [SD, 23.5]; mean difference, −16.4 [95% CI, −25.0 to −7.8]; P

BackgroundAchilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies.Methods and designThis is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle–tendon function, quality of life, pain and overall patient’s functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations.Ethics and disseminationThe protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals.Trial registration numberISRCTN: 54992179, assigned 12 January 2015. ClinicalTrials.gov:NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.

Introduction Shoulder pain is very common, with around 70% of cases due to disorders of the rotator cuff. Despite widespread provision of physiotherapy, there is uncertainty about which type of exercise and delivery mechanisms are associated with best outcomes. There is also uncertainty around the long-term benefits and harms of corticosteroid injection therapy, which is often used in addition to physiotherapy. The Getting it Right: Addressing Shoulder Pain trial will assess the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. Methods and analysis We are conducting a large multicentre randomised controlled trial (2×2 factorial design). We will recruit adults ≥18 years with a new episode of shoulder pain attributable to a rotator cuff disorder as per British Elbow and Shoulder Society guidelines, not currently receiving physiotherapy or being considered for surgery, from at least eight UK National Health Service primary care-based musculoskeletal and related physiotherapy services. Participants (n=704) will be randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (≤6 physiotherapy sessions); (2) best practice advice (one physiotherapy session); (3) corticosteroid injection then progressive exercise (≤6 sessions) or (4) corticosteroid injection then best practice advice (one session). The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score at 12 months. Secondary outcomes are: pain and function SPADI subdomains; health-related quality of life (Five-Level version of the EuroQol EQ-5D-5L); sleep disturbance; return to activity; global impression of change; health resource use; out-of-pocket expenses; work disability. A parallel within-trial economic evaluation will be conducted. The primary analysis will be intention to treat. Ethics and dissemination Research Ethics Committee approval (REC: 16/SC/0508) has been obtained. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal. Trial registration number ISRCTN16539266; EudraCT number: 2016-002991-28.

A linear encoder measuring vertical displacement during the heel-rise endurance test (HRET) enables the assessment of work and maximum height in addition to the traditional repetitions measure. We aimed to compare the test-retest reliability and agreement of these three outcome measures. Thirty-eight healthy participants (20 females, 18 males) performed the HRET on two occasions separated by a minimum of seven days. Reliability was assessed by the intraclass correlation coefficient (ICC) and agreement by a range of measures including the standard error of measurement (SEM), coefficient of variation (CV), and 95% limits of agreement (LoA). Reliability for repetitions (ICC = 0.77 (0.66, 0.85)) was equivalent to work (ICC = 0.84 (95% CI 0.76, 0.89)) and maximum height (ICC = 0.85 (0.77, 0.90)). Agreement for repetitions (SEM = 6.7 (5.8, 7.9); CV = 13.9% (11.9, 16.8%); LoA = −1.9 ± 37.2%) was equivalent to work (SEM = 419 J (361, 499 J); CV = 13.1% (11.2, 15.8%); LoA = 0.1 ± 34.8%) with maximum height superior (SEM = 0.8 cm (0.6, 1.0 cm); CV = 6.6% (5.7, 7.9%); LoA = 1.3 ± 17.1%). Work and maximum height demonstrated acceptable reliability and agreement that was at least equivalent to the traditional repetitions measure.

BackgroundClose contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults.ObjectivesWe aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences.DesignA pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study.SettingTrauma and orthopaedic departments of 24 NHS hospitals.ParticipantsAdults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded.InterventionsCCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern.Main outcome measuresFollow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud–Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol.ResultsWe recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference –0.65 points, 95% confidence interval (CI) –3.98 to 2.68 points; standardised effect size –0.04, 95% CI –0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%);p p = 0.002; medial: 3/274 (1%) vs. 18/248 (7%);p 95% from NHS perspective and 85% from societal perspective). Experiences of treatments were similar; both groups endured the impact of fracture, uncertainty regarding future function and the need for further interventions.LimitationsAssessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon.ConclusionsCCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months.Future workLonger-term follow-up of trial participants is under way to address concerns over potential later complications or additional procedures and their potential to impact on ankle function. Further study of the patient factors, radiological fracture patterns and outcomes, treatment responses and prognosis would also contribute to understanding the treatment pathway.Trial registrationCurrent Controlled Trials ISRCTN04180738.FundingThe National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 75. See the NIHR Journals Library website for further project information. This report was developed in association with the National Institute for Health Research Oxford Biomedical Research Unit funding scheme. The pilot phase was funded by the AO Research Foundation.

AimSlow recovery and disability after Achilles tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in the laboratory and is widely used in musculoskeletal treatments. However, evidence from adequately powered, robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.Methods230 adults starting Achilles rupture non-surgical management within 12 days of injury were randomised to PRP injection or dry needle insertion to the rupture gap, under local anaesthetic. Participants were blinded to study treatment and received standardised rehabilitation. Blinded outcome assessments were at 4, 7, 13, and 24 weeks. The primary outcome was muscle-tendon function assessed by work performed during the heel-rise endurance test (HRET), measured with the Limb Symmetry Index (LSI) (0–100%; 100% denotes full recovery) at 24 weeks. Secondary outcomes were the Achilles Tendon Rupture Score (ATRS), quality of life (SF-12), pain and goal attainment. The trial was prospectively registered.ResultsOf 230 participants, 114 were allocated to PRP injection (103 received PRP), 116 were allocated to and received placebo. At 24 weeks, 201/230 (87%) completed the HRET and 214/230 (93%) completed patient reported outcomes. Participant characteristics between the groups were similar. There was no difference between groups at 24 weeks in LSI (mean difference = -4.373; 95% CI −11.217 to 2.471; p=0.195). There were no differences in the secondary outcomes and adverse event rates.ConclusionThis trial design and standardised PRP preparation secure the first robust clinical trial evidence for PRP in managing Achilles tendon rupture, and suggest that PRP offers no patient benefit. The use of PRP in soft tissue injuries must be questionable unless supported by equally robust evidence indicating positive outcomes.

This case report summarises the presentation of a 28-year-old female with signs and symptoms characteristic of thoracic outlet syndrome, but who was later found to have an effort-induced Upper Extremity Deep Vein Thrombosis (UEDVT), otherwise known as Paget-Schroetter syndrome. Effort-induced UEDVT is rare, but the similarity between the signs and symptoms of thoracic outlet syndrome and this type of thrombosis can result in patients with this condition presenting to musculoskeletal therapists. The key features of the case are described, followed by an overview of UEDVT and the importance of recognising this condition in musculoskeletal therapy practice. The role of therapists in referring for early medical diagnostics is key to ensuring management of the thrombosis is instigated early, therefore reducing the risk of life threatening consequences such as pulmonary embolism.

Background\ud Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery.\ud \ud Methods/Design\ud This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud and Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment.\ud \ud Discussion\ud This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013.

Background: The physiological impairments most strongly associated with functional performance in older people are logically the most efficient therapeutic targets for exercise training interventions aimed at improving function and maintaining independence in later life.Objectives: The objectives of this review were to (1) systematically review the relationship between muscle power and functional performance in older people; (2) systematically review the effect of power training (PT) interventions on functional performance in older people; and (3) identify components of successful PT interventions relevant to pragmatic trials by scoping the literature.Methods: Our approach involved three stages. First, we systematically reviewed evidence on the relationship between muscle power, muscle strength and functional performance and, second, we systematically reviewed PT intervention studies that included both muscle power and at least one index of functional performance as outcome measures. Finally, taking a strong pragmatic perspective, we conducted a scoping review of the PT evidence to identify the successful components of training interventions needed to provide a minimally effective training dose to improve physical function.Results: Evidence from 44 studies revealed a positive association between muscle power and indices of physical function, and that muscle power is a marginally superior predictor of functional performance than muscle strength. Nine studies revealed maximal angular velocity of movement, an important component of muscle power, to be positively associated with functional performance and a better predictor of functional performance than muscle strength. We identified 31 PT studies, characterised by small sample sizes and incomplete reporting of interventions, resulting in less than one-in-five studies judged as having a low risk of bias. Thirteen studies compared traditional resistance training with PT, with ten studies reporting the superiority of PT for either muscle power or functional performance. Further studies demonstrated the efficacy of various methods of resistance and functional task PT on muscle power and functional performance, including low-load PT and low-volume interventions.Conclusions: Maximal intended movement velocity, low training load, simple training methods, low-volume training and low-frequency training were revealed as components offering potential for the development of a pragmatic intervention. Additionally, the research area is dominated by short-term interventions producing short-term gains with little consideration of the long-term maintenance of functional performance. We believe the area would benefit from larger and higher-quality studies and consideration of optimal long-term strategies to develop and maintain muscle power and physical function over years rather than weeks.

Cervical spine rotation is used by manual therapists as a premanipulative vertebrobasilar insufficiency (VBI) test to identify patients at risk of developing VBI post-manipulation. Investigations of the effect of rotation on vertebral artery blood flow have yielded conflicting results, the validity of the test being debated. It was the aim of this study, therefore, to investigate the effects of cervical spine rotation on vertebral artery blood flow. Transcranial Doppler sonography was used to measure intracranial vertebral artery blood flow in 30 young, healthy, female subjects, with the cervical spine in the neutral position and with sustained, end-of-range rotation. Statistically significant decreases in blood flow were demonstrated with contralateral rotation particularly, in the left (45.9+/-8.5 to 41.8+/-11.6 cm/s) and right (27.8+/-6.9 to 25.2+/-8.2 cm/s) vertebral arteries. Despite this change in blood flow, signs and symptoms of VBI were not demonstrated in these subjects. Nevertheless, these findings are of clinical importance, especially in patients who may have underlying vascular pathology. Thus, this study supports the use of the VBI test, in the absence of a more specific, sensitive and valid test, to assess the adequacy of hindbrain blood supply to identify those patients who may be at risk of serious complications post-manipulation.

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects (benefits and harms) of immobilisation compared with early movement protocols for acute lateral ankle ligament injuries.

We aimed to compare the effects of different ankle supports used after ankle injury/surgery on temporo-spatial gait characteristics. We conducted a randomized cross-over study including adult participants with no previous lower limb or neurological pathology, who underwent gait analysis on an electronic walkway in three different ankle supports, Tubigrip®, a stirrup brace and a walker boot. The 18 participants were an average age of 42 (SD 13, range 24-62) years and 14 (88%) were female. Compared to Tubigrip®, gait in the walker boot was slower (-0.19m/s, 95%CI -0.23 to -0.16, P

The incidence of ankle fractures is increasing rapidly due to the ageing demographic. In older patients with compromised distal circulation, conservative treatment of fractures may be indicated. High rates of malunion and complications due to skin fragility motivate the design of novel casting systems, but biomechanical stability requirements are poorly defined. This article presents the first quantitative study of ankle cast stability and hypothesises that a newly proposed close contact cast (CCC) system provides similar biomechanical stability to standard casts (SC). Two adult mannequin legs transected at the malleoli, one incorporating an inflatable model of tissue swelling, were stabilised with casts applied by an experienced surgeon. They were cyclically loaded in torsion, measuring applied rotation angle and resulting torque. CCC stiffness was equal to or greater than that of SC in two measures of ankle cast resistance to torsion. The effect of swelling reduction at the ankle site was significantly greater on CCC than on SC. The data support the hypothesis that CCC provides similar biomechanical stability to SC and therefore also the clinical use of CCC. They suggest that more frequent re-application of CCC is likely required to maintain stability following resolution of swelling at the injury site.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: To compare early ankle movement versus ankle immobilization after surgery for ankle fracture on clinical and patient-reported outcomes. BACKGROUND: A significant proportion of patients undergoing surgery for ankle fracture experience postoperative complications and delayed return to function. The risks and benefits of movement of the ankle in the first 6 weeks after surgery are not known, and clinical practice varies widely. METHODS: We searched bibliographic databases and reference lists to identify eligible trials. Two independent reviewers conducted data extraction and risk-of-bias assessments. RESULTS: Fourteen trials (705 participants) were included in the review, 11 of which were included in the meta-analysis. The quality of the trials was universally poor. The pooled effect of early ankle movement on function at 9 to 12 weeks after surgery compared to immobilization was inconclusive (standardized mean difference, 0.46; 95% confidence interval: -0.02, 0.93; P = .06; I(2) = 72%), and no differences were observed between groups at 1 year. The odds of venous thromboembolism were significantly lower with early ankle movement compared to immobilization (Peto odds ratio = 0.12; 95% confidence interval: 0.02, 0.71; P = .02; I(2) = 0%). Deep surgical site infection (Peto odds ratio = 7.08; 95% confidence interval: 1.39, 35.99; P = .02; I(2) = 0%), superficial surgical site infection, fixation failure, and reoperation to remove metalwork were more common after early ankle movement compared to immobilization. CONCLUSION: The quality of evidence is poor. The effects of early movement after ankle surgery on short-term functional outcomes are unclear, but there is no observable difference in the longer term. There is a small reduction in risk of postoperative thromboembolism with early ankle movement. Current evidence suggests that deep and superficial surgical site infections, fixation failure, and the need to remove metalwork are more common after early ankle movement. Level of Evidence Therapy, level 1a-.