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Scientific Articles   |    
Open Reduction and Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular FracturesA Multicenter, Randomized, Controlled Trial
C.M. Robinson, FRCSEd(Tr&Orth)1; E.B. Goudie, BMedSci(Hons), MRCSEd1; I.R. Murray, BMedSci(Hons), MRCSEd, Dip SEM2; P.J. Jenkins, FRCSEd(Tr&Orth)1; M.A. Ahktar, MRCSEd1; E.O. Read, BMedSci(Hons)1; C.J. Foster, MBChB1; K. Clark, BSc1; A.J. Brooksbank, FRCS(Tr&Orth)3; A. Arthur, FRCS(Tr&Orth)3; M.A. Crowther, FRCS(Tr&Orth)4; I. Packham, BMBS, BMedSci, FRCS(Tr&Orth)4; T.J. Chesser, FRCS(Tr&Orth)4
1 The Edinburgh Shoulder Clinic, The New Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SU, United Kingdom. E-mail address for C.M. Robinson: c.mike.robinson@ed.ac.uk
2 Scottish Centre for Regenerative Medicine, The University of Edinburgh, 5 Little France Drive, Edinburgh, EH16 4UU, United Kingdom
3 Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, 84 Castle Street, Glasgow, G4 0SF, United Kingdom
4 Department of Orthopaedic Surgery, Frenchay Hospital, Bristol, BS16 1LE, United Kingdom
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Investigation performed at The Edinburgh Shoulder Clinic, The New Royal Infirmary of Edinburgh, Little France, Edinburgh, Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, and Department of Orthopaedic Surgery, Frenchay Hospital, Bristol, United Kingdom

A commentary by Michael D. McKee, MD, FRCS(C), is linked to the online version of this article at jbjs.org.



Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Sep 04;95(17):1576-1584. doi: 10.2106/JBJS.L.00307
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Abstract

Background: 

There is a growing trend to treat displaced midshaft clavicular fractures with primary open reduction and plate fixation; whether such treatment results in improved patient outcomes is debatable. The aim of this multicenter, single-blinded, randomized controlled trial was to compare union rates, functional outcomes, and economic costs for displaced midshaft clavicular fractures that were treated with either primary open reduction and plate fixation or nonoperative treatment.

Methods: 

In a prospective, multicenter, stratified, randomized controlled trial, 200 patients between sixteen and sixty years of age who had an acute displaced midshaft clavicular fracture were randomized to receive either primary open reduction and plate fixation or nonoperative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant scores. Union was evaluated with use of three-dimensional computed tomography. Complications were recorded, and an economic evaluation was performed.

Results: 

The rate of nonunion was significantly reduced after open reduction and plate fixation (one nonunion) as compared with nonoperative treatment (sixteen nonunions) (relative risk = 0.07; p = 0.007). Group allocation to nonoperative treatment was independently predictive of the development of nonunion (p = 0.0001). Overall, DASH and Constant scores were significantly better after open reduction and plate fixation than after nonoperative treatment at the time of the one-year follow-up (DASH score, 3.4 versus 6.1 [p = 0.04]; Constant score, 92.0 versus 87.8 [p = 0.01]). However, when patients with nonunion were excluded from analysis, there were no significant differences in the Constant scores or DASH scores at any time point. Patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry in the open reduction and plate fixation group (p < 0.0001). The cost of treatment was significantly greater after open reduction and plate fixation (p < 0.0001).

Conclusions: 

Open reduction and plate fixation reduces the rate of nonunion after acute displaced midshaft clavicular fracture compared with nonoperative treatment and is associated with better functional outcomes. However, the improved outcomes appear to result from the prevention of nonunion by open reduction and plate fixation. Open reduction and plate fixation is more expensive and is associated with implant-related complications that are not seen in association with nonoperative treatment. The results of the present study do not support routine primary open reduction and plate fixation for the treatment of displaced midshaft clavicular fractures.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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