United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.

BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. METHODS: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. DISCUSSION: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

Platelet-Rich Plasma Injections as a Treatment for Refractory Patellar Tendinosis: A Meta-Analysis of Randomised Trials.

Purpose: Patellar tendinosis (PT) is a common condition amongst athletes. In this study, we perform a meta-analysis on randomised controlled trials (RCTs) to evaluate the use of platelet-rich plasma (PRP) for refractory PT. Methods: A literature search was undertaken in various databases from their year of inception to October 2015. The primary outcome measure was the Victorian Institute of Sports Assessment-Patella (VISA-P) score. Results: We identified 2 RCTs comparing PRP injections to alternative treatment options (extracorporeal shockwave therapy [ESWT] and dry needling of the tendon). Meta-analysis showed no significant difference in mean VISA-P scores between PRP injection and control at early assessment (2 or 3 months; estimated difference in means, 11.9; standard error [SE], 7.4; 95% confidence interval [CI], -2.7 to 26.4; p=0.109). However, PRP was statistically better than control with regards to VISA-P scores at longer follow-up (6 months or longer; estimated difference in means, 12.7; SE, 4.4; 95% CI, 4.1 to 21.3; p=0.004). Conclusions: There is a paucity of RCTs evaluating the role of PRP in PT. Our results suggest that, based on limited evidence, PRP is superior over other established non-surgical treatments (dry needling and ESWT) for refractory PT. Larger RCTs may allow better characterisation of the role of PRP in this condition.

The 6-Hour Rule for Surgical Debridement of Open Tibial Fractures: A Systematic Review and Meta-Analysis of Infection and Nonunion Rates.

OBJECTIVES: The aim of this study was a systematic review and meta-analysis of studies comparing early (<6 hours) versus late (>6 hours) surgical debridement of open tibial fractures, with regards to infection and nonunion rates. METHODS: A systematic literature search of MEDLINE, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature (1961 to present), Allied and Complementary Medicine, and COCHRANE databases was conducted using any combination of the key words: "open," "tibial," and "fractures." After appropriate screening, 7 studies were included for analysis. Inclusion criteria were studies assessing the relation between time to debridement from injury and infection and/or nonunion rates. RESULTS: Three studies (n = 365) evaluated overall infection rates that varied from 7.7% to 8.9% in the early group versus 1%-18.5% in the late group. Three studies (n = 197) evaluated deep infection rates that varied from 13% to 18.5% in the early group versus 7.1%-18.6% in the late group. Four studies (n = 245) evaluated nonunion rates that varied from 13.2% to 26.1% in the early group versus 0%-32.6% in the late group. Meta-analysis showed no statistical difference between groups with regards to overall infection rates (risk ratio = 1.32; 95% CI, 0.54-3.23; P = 0.55), deep infection rates (risk ratio = 0.99; 95% CI, 0.48-2.07; P = 0.98), and nonunion rates (risk ratio = 1.49; 95% CI, 0.64-3.49; P = 0.36). CONCLUSIONS: The available literature suggests that there is no obvious difference in the overall/deep infection and nonunion rates between open tibial fractures debrided within 6 hours and those debrided at more than 6 hours. The findings presented here would appear to indicate that judicious delays of greater than 6 hours may not result in a significantly increased risk of adverse events or peri-operative morbidity. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.