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

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

doi:10.1186/1745-6215-12-57

Abstract

BackgroundClavicle 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/DesignWe 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.DiscussionThis 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 RegistrationUnited 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.

Highlights

This article presents the protocol for a multicentre randomised controlled trial
There is some evidence that conservative management affects the outcome in terms of upper limb function [8,9,10] and that treatment of non-unions produces inferior results [11,12]
Setting Patients will be recruited from the following centres: Royal Free Hospital NHS Trust, University College Hospitals NHS Foundation Trust, St Thomas’ and Guy’s Hospitals NHS Foundation Trust, St George’s Hospital NHS Trust, Yeovil District Hospital NHS Foundation Trust, North Bristol NHS Trust, University Hospitals Coventry and Warwick NHS Foundation Trust, The Ipswich Hospital NHS Trust

Summary

Introduction

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. Management of mid-shaft clavicular fractures is often challenging and the outcome can be unsatisfactory. There is some evidence that conservative management affects the outcome in terms of upper limb function [8,9,10] and that treatment of non-unions produces inferior results [11,12]. Few comparative studies of surgical versus non-surgical treatment for mid-shaft clavicle fractures are available, and contradictory results have been obtained [13,14,15]

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