The Adhesive Capsulitis Corticosteroid and Dilation (ACCorD) randomized controlled trial.

Aims: Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. Methods: In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral. Results: We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research. Conclusion: We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder.

Reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical treatment for older adults with acute 3- or 4-part fractures of the proximal humerus: study protocol for a randomised controlled trial (PROFHER-2: PROximal Fracture of Humerus Evaluation by Randomisation - Trial Number 2).

BACKGROUND: Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- and 4-part fractures despite a lack of good quality evidence as to whether one type of arthroplasty is superior to the other, and whether surgery is better than non-surgical management. The PROFHER-2 trial has been designed as a pragmatic, multicentre randomised trial to compare the clinical and cost-effectiveness of RSA vs HA vs Non-Surgical (NS) treatment in patients with 3- and 4-part PHF. METHODS: Adults over 65 years of age presenting with acute radiographically confirmed 3- or 4-part fractures, with or without associated glenohumeral joint dislocation, who consent for trial participation will be recruited from around 40 National Health Service (NHS) Hospitals in the UK. Patients with polytrauma, open fractures, presence of axillary nerve palsy, pathological (other than osteoporotic) fractures, and those who are unable to adhere to trial procedures will be excluded. We will aim to recruit 380 participants (152 RSA, 152 HA, 76 NS) using 2:2:1 (HA:RSA:NS) randomisation for 3- or 4-part fractures without joint dislocation, and 1:1 (HA:RSA) randomisation for 3- or 4-part fracture dislocations. The primary outcome is the Oxford Shoulder Score at 24 months. Secondary outcomes include quality of life (EQ-5D-5L), pain, range of shoulder motion, fracture healing and implant position on X-rays, further procedures, and complications. Independent Trial Steering Committee and Data Monitoring Committee will oversee the trial conduct, including the reporting of adverse events and harms. DISCUSSION: The PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65 years or over who sustain 3- and 4-part proximal humeral fractures. The pragmatic design and recruitment from around 40 UK NHS hospitals will ensure immediate applicability and generalisability of the trial findings. The full trial results will be made available in a relevant open-access peer-reviewed journal. TRIAL REGISTRATION: ISRCTN76296703. Prospectively registered on 5th April 2018.

Lateral compression type 1 fracture fixation in the elderly (L1FE): study protocol for a randomised controlled trial (with internal pilot) comparing the effects of INFIX surgery and non-surgical management for treating patients with lateral compression type 1 (LC-1) fragility fractures.

BACKGROUND: Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and related complications. INFIX is a pelvic fixation device used in younger patients with high-energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients' ability to mobilise and reduce the risk of immobility-related complications. However, there is a risk of complications related to surgery, and robust evidence is required on patient outcomes. This study will investigate the clinical and cost-effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. METHODS: A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications. DISCUSSION: The L1FE study aims to compare the clinical and cost-effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision-making and allocation of NHS resources. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019.

An investigation of the control of quadriceps in people who are hypermobile; a case control design. Do the results impact our choice of exercise for people with symptomatic hypermobility?

BACKGROUND: People with symptomatic hypermobility have altered proprioception however, the origin of this is unclear and needs further investigation to target rehabilitation appropriately. The objective of this investigation was to explore the corticospinal and reflex control of quadriceps and see if it differed between three groups of people: those who have symptomatic hypermobility, asymptomatic hypermobility and normal flexibility. METHODS: Using Transcranial Magnetic Stimulation (TMS) and electrical stimulation of peripheral nerves, motor evoked potentials (MEPs) and Hoffman (H) reflexes of quadriceps were evoked in the three groups of people. The threshold and latency of MEPs and the slope of the input-output curves and the amplitude of MEPs and H reflexes were compared across the groups. RESULTS: The slope of the input-output curve created from MEPs as a result of TMS was steeper in people with symptomatic hypermobility when compared to asymptomatic and normally flexible people (p = 0.04). There were no other differences between the groups. CONCLUSION: Corticospinal excitability and the excitability at the motoneurone pool are not likely candidates for the origin of proprioceptive loss in people with symptomatic hypermobility. This is discussed in the light of other work to suggest the receptor sitting in hypermobile connective tissue is a likely candidate. This suggests that treatment aimed at improving receptor responsiveness through increasing muscle tone, may be an effective rehabilitation strategy.

Health-related quality of life and functional outcome measures for pediatric multiple injury: A systematic review and narrative synthesis.

BACKGROUND: Pediatric multiple injury is a major cause of mortality and morbidity worldwide, with varied long-term sequelae. To improve care, a better understanding of the outcome tools used following multiple injury is needed. OBJECTIVES: This study aimed to (1) identify the outcome tools used to assess functional and health-related quality of life outcomes in pediatric multiple injury and to (2) describe the tool domains and validity. METHODS: Eligible studies were those that included pediatric participants aged 0 to 17 years who experienced multiple injury or severe trauma based on Injury Severity Score/Abbreviated Injury Scale score and a functional outcome tool was used to assess outcomes (e.g., physical, psychological, quality of life). Excluded study designs were editorials, narrative, and systematic reviews. RESULTS: Twenty-two papers were included encompassing 16,905 participants and 34 different outcome tools. Ten tools were validated in children of which 4 were multiple injury specific; 18 were validated in adults of which 8 were trauma specific, and 6 were previously unvalidated. The tools were a mixture of patient reported (7 of 10 validated in children and 13 of 18 validated in adults) and clinician reported (3 of 10 validated in children and 2 of 13 validated in adults). Pediatric tool domains assessed were function, mobility, activities of daily living, pain, school, cognition, emotional domains, mental health, behavior, and high-risk behaviors. Using adult-validated tools to assess children may not capture the children's true function and health-related quality of life. CONCLUSION: There was a lack of consistency in the outcome tools used following multiple injury in children. Adult-validated measures may not accurately capture pediatric outcomes after multiple injury. To fully understand the impact of pediatric multiple injury and make comparisons between studies, development of a core outcome set is required. LEVEL OF EVIDENCE: Quantitative observational studies, level III.

Effectiveness of surgical fixation for lateral compression type one (LC-1) fragility fractures of the pelvis: a systematic review.

OBJECTIVES: To undertake a systematic review of the evidence base for the effectiveness of surgical fixation of lateral compression (LC-1) fragility fractures of the pelvis compared with non-surgical approaches. SEARCHES: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and two international trials registers were searched up to January 2017 (MEDLINE to February 2019) for studies of internal or external fixation of fragility fractures of the pelvis. PARTICIPANTS: Patients with lateral compression pelvic fractures, sustained as the result of a low-energy mechanism, defined as a fall from standing height or less. INTERVENTIONS: Surgery using either external or internal fixation devices. Conservative non-surgical treatment was the defined comparator. OUTCOME MEASURES: Outcomes of interest were patient mobility and function, pain, quality of life, fracture union, mortality, hospital length of stay and complications (additional operative procedures, number and type of adverse events and serious adverse events). QUALITY ASSESSMENT AND SYNTHESIS: The Joanna Briggs Institute Checklist for Case Series was used to assess the included studies. Results were presented in a narrative synthesis. RESULTS: Of 3421 records identified, four retrospective case series met the inclusion criteria. Fixation types were not consistent between studies or within studies and most patients had more than one type of pelvic fixation. Where reported, mobility and function improved post-surgery, and a reduction in pain was recorded. Length of hospital stay ranged from 4 days to 54 days for surgical fixation of any type. Reported complications and adverse outcomes included: infections, implant loosening, pneumonia and thrombosis. Use of analgesia was not reported. CONCLUSIONS: There is insufficient evidence to support guidance on the most effective treatment for patients who fail to mobilise after sustaining an LC-1 fragility fracture. TRIAL REGISTRATION NUMBER: CRD42017055872.