UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

The Clavicle Trial A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures

Ahrens, PM; Garlick, NI; Barber, J; Tims, EM; (2017) The Clavicle Trial A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures. The Journal of Bone and Joint Surgery , 99 (16) pp. 1345-1354. 10.2106/JBJS.16.01112. Green open access

[thumbnail of Barber_Clavicle Trial JBJS - final.pdf]
Preview
Text
Barber_Clavicle Trial JBJS - final.pdf - Accepted Version

Download (355kB) | Preview

Abstract

Background: The treatment of displaced midshaft clavicle fractures remains controversial. Methods: We undertook a multicenter randomized controlled trial to compare effectiveness and safety between nonoperative management and ORIF (open reduction and internal fixation) for displaced midshaft clavicle fractures in adults. Three hundred and one eligible adult patients were randomized to 1 of the 2 treatment groups and followed at 6 weeks, 3 months, and 9 months after recruitment. The primary outcome was the rate of radiographically evident nonunion at 3 months following treatment. Secondary outcomes were the rate of radiographically evident nonunion at 9 months, limb function measured using the Constant-Murley Score and DASH (Disabilities of the Arm, Shoulder and Hand) score, and patient satisfaction. Results: There was no difference in the proportion of patients with radiographic evidence of nonunion at 3 months between the operative (28%) and nonoperative (27%) groups, whereas at 9 months the proportion with nonunion was significantly lower (p < 0.001) in the operative group (0.8%) than in the nonoperative group (11%). The DASH and ConstantMurley scores and patient satisfaction were all significantly better in the operative group than in the nonoperative group at 6 weeks and 3 months. Conclusions: Although at 3 months there was no evidence that surgery had reduced the rate of nonunion of displaced midshaft clavicle fractures, at 9 months nonoperative treatment had led to a significantly higher nonunion rate (11% compared with <1%). The rate of secondary surgical intervention during the trial period was 12 (11%) of the 147 patients in the nonoperative group. ORIF is a safe and reliable intervention with superior early functional outcomes and should be considered for patients who sustain this common injury. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Type: Article
Title: The Clavicle Trial A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures
Open access status: An open access version is available from UCL Discovery
DOI: 10.2106/JBJS.16.01112
Publisher version: http://doi.org/10.2106/JBJS.16.01112
Language: English
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Statistical Science
URI: https://discovery.ucl.ac.uk/id/eprint/1571994
Downloads since deposit
286Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item