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Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults - The Clavicle Trial: study protocol for a multicentre randomized controlled trial

Authors: Umile Giuseppe Longo, Sughran Banerjee, Julie Barber, Andrew Chambler, Carlos Cobiella, Steven Corbett, Mark Crowther, Steven Drew, Andrea Francis, Marcus Lee, Nicholas Garlick, Iain Packham, Yemi Pearse, Andrew Richards, Chris Roberts, Duncan Tennent, Emily Tims, Philip Michael Ahrens

Published in: Trials | Issue 1/2011

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Abstract

Background

Clavicle fractures account for around 4% of all fractures and up to 44% of fractures of the shoulder girdle. Fractures of the middle third (or mid-shaft) account for approximately 80% of all clavicle fractures. Management of this group of fractures is often challenging and the outcome can be unsatisfactory. In particular it is not clear whether surgery produces better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform our decision.

Methods/Design

We aim to undertake a multicentre randomised controlled trial evaluating the effectiveness and safety of conservative management versus open reduction and internal fixation for displaced mid-shaft clavicle fractures in adults. Surgical treatment will be performed using the Acumed clavicle fixation system. Conservative management will consist of immobilisation in a sling at the side in internal rotation for 6 weeks or until clinical or radiological union. We aim to recruit 300 patients. These patients will be followed-up for at least 9 months. The primary endpoint will be the rate of non-union at 3 months following treatment. Secondary endpoints will be limb function measured using the Constant-Murley Score and the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 9 months post-operatively.

Discussion

This article presents the protocol for a multicentre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.

Trial Registration

United Kingdom Clinical Research Network ID: 8665. The date of registration of the trial is 07/09/2006. The date the first patient was recruited is 18/12/2007.
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Metadata
Title
Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults - The Clavicle Trial: study protocol for a multicentre randomized controlled trial
Authors
Umile Giuseppe Longo
Sughran Banerjee
Julie Barber
Andrew Chambler
Carlos Cobiella
Steven Corbett
Mark Crowther
Steven Drew
Andrea Francis
Marcus Lee
Nicholas Garlick
Iain Packham
Yemi Pearse
Andrew Richards
Chris Roberts
Duncan Tennent
Emily Tims
Philip Michael Ahrens
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-57

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