Achten, Juul, Parsons, Nicholas R., Kearney, Rebecca S., Dutton, S., Petrou, Stavros, Ollivere, B., Lamb, S. E. and Costa, Matthew L. (2017) Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon : protocol for UK Study of Tendo Achilles Rehabilitation (UK STAR). BMJ Open, 7 . e019628. doi:10.1136/bmjopen-2017-019628 ISSN 2044-6055.

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Abstract

Introduction
Achilles tendon rupture affects over 11,000 people yearly in the UK, and the incidence is increasing. Controversy remains with regards the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multi-centre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture.

Methods and analysis
All adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population.
Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the NHS. Standardised protocols will be followed, but details of plaster material and brace will be as per the site’s usual practice.
A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Rupture Score (ATRS) at 9 months. Quality of life and resource use will also be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis.
Results are expected to be available in the summer of 2019.

Ethics and dissemination.
National Research Ethic Committee approved this study on the 18th of March 2016 (16/SC/0109).
The NIHR Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted upon completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost effectiveness of the treatment of this injury.

Item Type:	Journal Article
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	1 October 2017
Dates:	Date Event 1 October 2017 Published 15 September 2017 Accepted 24 October 2017 Available
Volume:	7
Article Number:	e019628
DOI:	10.1136/bmjopen-2017-019628
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	27 September 2017
Date of first compliant Open Access:	30 January 2018

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