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Abstract Background Distal radius fractures are common fractures in older adults and associated with increased risk of future functional decline and hip fracture. Whether lower limb muscle strength and balance are impaired in this patient population is uncertain. To help inform rehabilitation requirements, this systematic review aimed to compare lower limb muscle strength and balance between older adults with a distal radius fracture with matched controls, and to synthesise lower limb muscle strength and balance outcomes in older adults with a distal radius fracture. Methods We searched Embase, MEDLINE, and CINAHL (1990 to 25 May 2022) for randomised and non-randomised controlled clinical trials and observational studies that measured lower limb muscle strength and/or balance using instrumented measurements or validated tests, in adults aged ≥ 50 years enrolled within one year after distal radius fracture. We appraised included observational studies using a modified Newcastle-Ottawa Scale and included randomised controlled trials using the Cochrane risk-of-bias tool. Due to the clinical and methodological heterogeneity in included studies, we synthesised results narratively in tables and text. Results Nineteen studies (10 case-control studies, five case series, and four randomised controlled trials) of variable methodological quality and including 1835 participants (96% women, mean age 55–73 years, median sample size 82) were included. Twelve included studies (63%) assessed strength using 10 different methods with knee extension strength most commonly assessed (6/12 (50%) studies). Five included case-control studies (50%) assessed lower limb strength. Cases demonstrated impaired strength during functional tests (two studies), but knee extension strength assessment findings were conflicting (three studies). Eighteen included studies (95%) assessed balance using 14 different methods. Single leg balance was most commonly assessed (6/18 (33%) studies). All case-control studies assessed balance with inconsistent findings. Conclusion Compared to controls, there is some evidence that older adults with a distal radius fracture have impaired lower limb muscle strength and balance. A cautious interpretation is required due to inconsistent findings across studies and/or outcome measures. Heterogeneity in control participants’ characteristics, study design, study quality, and assessment methods limited synthesis of results. Robust case-control and/or prospective observational studies are needed. Registration International prospective register of systematic reviews (date of registration: 02 July 2020, registration identifier: CRD42020196274).

Abstract Background Patellar dislocations mainly affect adolescents and young adults. After this injury, patients are usually referred to physiotherapy for exercise-based rehabilitation. Currently, limited high-quality evidence exists to guide rehabilitation practice and treatment outcomes vary. A full-scale trial comparing different rehabilitation approaches would provide high-quality evidence to inform rehabilitation practice. Whether this full-scale trial is feasible is uncertain: the only previous trial that compared exercise-based programmes in this patient population had high loss to follow-up. This study aims to assess the feasibility of conducting a future full-scale trial comparing the clinical and cost-effectiveness of two different rehabilitation approaches for people with an acute patellar dislocation. Methods Two-arm parallel external pilot randomised controlled trial and qualitative study. We aim to recruit at least 50 participants aged ≥ 14 years with an acute first-time or recurrent patellar dislocation from at least three English National Health Service hospitals. Participants will be randomised 1:1 to supervised rehabilitation (four to six, one-to-one, physiotherapy sessions of advice and prescription of tailored progressive home exercise over a maximum of 6 months) or self-managed rehabilitation (one physiotherapy session of self-management advice, exercise, and provision of self-management materials). Pilot objectives are (1) willingness to be randomised, (2) recruitment rate, (3) retention, (4) intervention adherence, and (5) intervention and follow-up method acceptability to participants assessed through one-to-one semi-structured interviews (maximum 20 participants). Follow-up data will be collected 3, 6, and 9 months after randomisation. Quantitative pilot and clinical outcomes will be numerically summarised, with 95% confidence intervals generated for the pilot outcomes using Wilson’s and exact Poisson methods as appropriate. Discussion This study will assess the feasibility of conducting a full-scale trial comparing supervised versus self-managed rehabilitation for people after acute first-time or recurrent patellar dislocation. This full-scale trial’s results would provide high-quality evidence to guide rehabilitation provision for patients with this injury. Trial registration ISRCTN registry ISRCTN14235231 . Registered on 09 August 2022.

Abstract Background Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. Methods Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. Results The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. Conclusions The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

Abstract 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 .

Abstract Background Segmental tibial fractures are fractures in two or more areas of the tibial diaphysis resulting in a separate intercalary segment of the bone. Surgical fixation is recommended for patients with segmental tibial fractures as non-operative treatment outcomes are poor. The most common surgical interventions are intramedullary nailing (IMN) and circular frame external fixation (CFEF), but evidence about which is better is of poor quality. An adequately powered randomised controlled trial (RCT) to determine optimum treatment is required. STIFF-F aimed to assess the feasibility of a multicentre RCT comparing IMN with CFEF for segmental tibial fracture. Methods STIFF-F was a mixed-methods feasibility study comprising a pilot RCT conducted at six UK Major Trauma Centres, qualitative interviews drawing on Phenomenology and an online survey of rehabilitation. The primary outcome was recruitment rate. Patients, 16 years and over, with a segmental tibial fracture (open or closed) deemed suitable for IMN or CFEF were eligible to participate. Randomisation was stratified by site using random permuted blocks of varying sizes. Participant or assessor blinding was not possible. Interviews were undertaken with patients about their experience of injury, treatment, recovery and participation. Staff were interviewed to identify contextual factors affecting trial processes, their experience of recruitment and the treatment pathway. An online survey was developed to understand the rehabilitation context of the treatments. Results Eleven patients were screened and three recruited to the pilot RCT. Nineteen staff and four patients participated in interviews, and 11 physiotherapists responded to the survey. This study found the following: (i) segmental tibial fractures were rarer than anticipated, (ii) the complexity of the injury, study setup times and surgeon treatment preferences impeded recruitment, (iii) recovery from a segmental tibial fracture is challenging, and rehabilitation protocols are inconsistent and (iv) despite the difficulty recruiting, staff valued this research question and strived to find a way forward. Conclusion The proposed multicentre RCT comparing IMN with CFEF is not feasible. This study highlighted the difficulty of recruiting patients to an RCT of a complex rare injury over a short time period. Trial registration The study was registered with the International Standard Randomised Controlled Trials Number Registry: ISRCTN11229660

Abstract Background Hip fracture is common, affecting 20% of women and 10% of men during their lifetime. The trajectory of patients’ recovery as they transition from the acute hospital setting to their usual residence is poorly understood. Recently, the use of activity trackers to monitor physical activity during recovery has been investigated as a way to explore this trajectory. Methods This prospective observational cohort study followed patients from hospital to home as they recovered from a hip fracture. Participants were recruited from a single centre and provided with a 3-axis logging accelerometer worn as a pendant, for 16 weeks from recruitment. Participants received monthly follow-up visits which included questions about wearing the monitor. Monthly activity monitor data were also downloaded. Participant activity was estimated from the monitor data using the calibrated “Euclidean Norm Minus One” (ENMO) metric. Polynomial mixed-effects modelling was used to evaluate the difference between the weekly activity trends of 2 groups of participants: those with and without independent mobility at 16 weeks (defined by whether aids or personal assistance were required to mobilise). Results Twenty-nine participants from 125 eligible patients were recruited. Of these, 19 (66%) reported being aware of wearing the monitor at least some of the time. Fourteen (48%) participants withdrew before study completion. Data for thirteen (45%) participants were of sufficient quantity to be included in the activity modelling procedure. Of these, 8 reported independent mobility at 16 weeks post-surgery, and 5 did not. By week 7, the weekly predicted mean ENMO ( ENMO ¯ W $$ {\overline{ENMO}}_W $$ ) values were significantly different between the two participant groups, demonstrating feasibility of the model’s ability to predict which patients will report independent mobility at 16 weeks. Conclusions This is the first study to our knowledge to investigate acceptability and feasibility of a pendant-worn activity monitor in this patient cohort. Acceptability of wearing the monitor and feasibility of recruitment and retention of participants were limited. Future research into the use of activity monitors in this population should use minimally intrusive devices which are acceptable to this population. Study registration MoHIP is a sub-study of the World Hip Trauma Evaluation (WHiTE) Study (ISRCTN 63982700).

Abstract Background The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised trial. Methods/design UK STAR is a 1:1, multi-centre, parallel, two-arm, superiority randomised controlled trial. This study aims to evaluate the use of functional bracing compared to plaster cast for the management of acute Achilles tendon rupture in adult patients treated non-operatively. The primary outcome is the Achilles Tendon Rupture Score measured at 9 months after injury and will be estimated based on a linear mixed effects regression model adjusted for the stratification factor (centre) and other key prognostic variables. Secondary outcomes include complications, quality of life and resource use evaluated at 8 weeks and at 3, 6 and 9 months after the injury. Missing data will be summarised and reported by treatment arm. Full details of the planned analysis methods are described in this paper. Further study design details are published in the UK STAR protocol. Discussion The planned statistical analyses for UK STAR aim to reduce the risk of outcome reporting bias arising from prior data knowledge. Any changes or deviations from the current SAP will be described and justified in the final study report. Trial registration International Standard Randomised Controlled Trial Number Registry, ISRCTN62639639. Registered on 22 June 2016.

Abstract Background Displaced intracapsular hip fractures are typically treated with hemiarthroplasty (HA) or total hip arthroplasty (THA). A number of professional bodies recommend considering THA for patients that were independently mobile and cognitively intact before injury. The aim of this study was to compare the outcomes between HA and THA for independently mobile older adults with hip fractures. Methods A systematic review and meta-analysis of RCTs was undertaken alongside analysis of a propensity score matched national cohort of older adults (aged > 60) with hip fractures. Participants were identified for the propensity score matched cohort from the National Hip Fracture Database (NHFD), which was linked to Hospital Episode Statistics (HES) and civil death registration data. The primary outcomes were 12-month dislocation, revision, and mortality. The secondary outcomes were length of stay, discharge home, unplanned re-admission, functional outcomes, and health-related quality of life. Results Five RCTs reported higher THA dislocation but this was not statistically significant (THA risk ratio [RR] 2.77, 95% CI 0.81 to 9.48). However, THA dislocation was significantly higher in the national observational dataset (sub-distribution hazard ratio [SHR] 1.73, 95% CI 1.24 to 2.41). Meta-analysis of data from four RCTs did not identify a significant difference in terms of revision (RR 1.52, 95% CI 0.56 to 4.14). However, THA revision was significantly lower in the national dataset (SHR 0.66, 95% CI 0.48 to 0.90). Meta-analysis of data from 5 RCTs suggested higher mortality amongst patients undergoing HA (RR 0.63, 95% CI 0.38 to 1.04), which was also observed within the national registry dataset (hazard ratio 0.45, 95% CI 0.37 to 0.54). Conclusions National clinical registries can provide important context when interpreting RCT data, which may alone be inadequate for comparing the safety profile of surgical interventions. These data suggest that THA is at significantly higher risk of dislocation but lower risk of revision within 12 months. The finding from both RCT and clinical registry data that THA is associated with lower 12-month mortality amongst the fittest patients with hip fractures requires urgent further study to determine whether or not this can be replicated in other balanced populations.

Abstract Background In the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high. One of the factors which may reduce the risk of surgical site infection is the type of dressing applied over the closed incision. The WHIST trial evaluates the effects of negative-pressure wound therapy (NPWT) compared with standard dressings. Methods/design The WHIST trial is a multicentre, parallel group, randomised controlled trial. The primary outcome is the rate of deep surgical site infection at 30 days after major trauma. Secondary outcomes are measured at 3 and 6 months post-randomisation and include the Disability Rating Index, the EuroQoL EQ-5D-5 L, the Doleur Neuropathique Questionnaire, a patient-reported scar assessment, and record of complications. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full WHIST protocol has already been published. Discussion This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data driven results. Trial registration International Standard Randomised Controlled Trials database, ISRCTN12702354. Registered on 9 December 2015.

Abstract Background Patients can struggle to make sense of trials in emergency situations. This study examines patient experience of participating in the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) study, a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT). Methods The aim of the study was to understand the patient’s lived experience of taking part in a trial of wound dressings. Interviews drawing on Phenomenology were undertaken with a purposive sample of 20 patients, on average 12 days into their hospital stay from July 2012–July 2013. Results The participants were vulnerable due to the emotional and physical impact of injury. They expressed their trial experience through the theme of being compromised identified in categories of being dependent, being trusting, being grateful and being without experience. Participants felt dependent on and trusted the team to make the right decisions for them and not cause them harm. Their hopes for future recovery were also invested within the expertise of the team. Despite often not being well enough to consent to the study prior to surgery, they wished to be involved as much as possible. In agreeing to take part they expressed gratitude for their care, wanted to be helpful to others and considered the trial interventions to be a small component in relation to the enormity of their injury and broader treatment. In making sense of the trial they felt they could not understand the interventions without experience of them but if they received NPWT they developed a strong technological preference for this intervention. Conclusions Patients prefer to be involved in studies within the limits of their capacity, despite not being able to provide informed consent. A variety of sources of knowledge may enable participants to feel that they have a better understanding of the interventions. Professional staff need to be aware of the situated nature of decision making where participants invest their hopes for recovery in the team. Trial registration Current Controlled Trials, ID: ISRCTN33756652. Registered on 24 February 2012.

Abstract Background Distal femoral fractures are a source of considerable morbidity and best treatment is currently uncertain. The Trial of Acute Femoral Fracture Fixation (TrAFFix) is a randomised, parallel-group feasibility study designed to inform the design of a later, definitive clinical trial comparing intramedullary nails and locking plates for the treatment of distal femoral fractures. Methods/design Patients aged 50 years and older with a femoral fracture within the distal two Müller squares are potentially eligible for inclusion. Participants are randomly allocated to receive fixation with either an intramedullary nail or a distal locking plate. Measurements (EuroQol 5 Dimensions, Dementia Quality of Life, Disability Rating Index) are collected at baseline, 6 weeks and 4 months. The recruitment rate will be assessed across seven participating centres over a total of 52 centre-months which is expected after 10 months of recruitment. Objectives are – feasibility phase, to assess recruitment rate and completion rate of the primary outcome measure; process evaluation, to assess the generalisability and likely success of a future trial; definitive trial, quantify and draw inferences on observed differences in health-related quality of life at 4 months between the study intervention groups (nail versus plate). A favourable opinion was granted by the Wales Research Ethics Committee (16/WA/0225), study-wide NHS approval was given by the Health Research Authority (IRAS 206745), and participating NHS trusts provided local approvals. This study was funded by the National Institute for Health Research Health Technology Assessment (HTA 15/59/22). Discussion This is the protocol for a feasibility study conducted prior to any future definitive trial. The estimates of participant recruitment rate and proportion of data completion will be coupled with outputs from the process evaluation to make a final decision regarding feasibility Trial registrations The study is registered with the National Institute for Health Research Portfolio (CPMS ID: 32536) and the ISRCTN registry ( ISRCTN92089567 ) on 26 May 2016.