Open Reduction and Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures A Multicenter, Randomized, Controlled Trial

The Edinburgh Shoulder Clinic, The New Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SU, United Kingdom. E-mail address for C.M. Robinson: .
The Journal of Bone and Joint Surgery (Impact Factor: 4.31). 09/2013; 95(17):1576-84. DOI: 10.2106/JBJS.L.00307
Source: PubMed

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

1 Follower
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Fractures of the clavicle present very common injuries with a peak of incidence in young active patients. Recently published randomized clinical trials demonstrated an improved functional outcome and a lower rate of nonunions in comparison to non-operative treatment. Anterior chest wall numbness due to injury of the supraclavicular nerve and postoperative pain constitute common surgery related complications in plate fixation of displaced clavicle fractures. We recently developed a technique for mini open plating (MOP) of the clavicle to reduce postoperative numbness and pain. The purpose of this study was to analyze the size of anterior chest wall numbness and the intensity of postoperative pain in MOP in comparison to conventional open plating (COP) of clavicle fractures. 24 patients (mean age 38.2 ± 14.2 yrs.) with a displaced fracture of the clavicle (Orthopaedic Trauma Association B1.2-C1.2) surgically treated using a locking compression plate (LCP) were enrolled. 12 patients underwent MOP and another 12 patients COP. Anterior chest wall numbness was measured with a transparency grid on the second postoperative day and at the six months follow-up. Postoperative pain was evaluated using the Visual Analog Scale (VAS). Mean ratio of skin incision length to plate length was 0.61 ± 0.04 in the MOP group and 0.85 ± 0.06 in the COP group (p < 0.05). Mean ratio of the area of anterior chest wall numbness to plate length was postoperative 7.6 ± 5.9 (six months follow-up 4.7 ± 3.9) in the MOP group and 22.1 ± 19.1 (16.9 ± 14.1) in the COP group (p < 0.05). Mean VAS was 2.6 ± 1.4 points in the MOP group and 3.4 ± 1.6 points in the COP group (p = 0.20). In our study, MOP significantly reduced anterior chest wall numbness in comparison to a conventional open approach postoperative as well as at the six months follow-up. Postoperative pain tended to be lower in the MOP group, however this difference was not statistically significant. NCT02247778 . Registered 21 September 2014.
    BMC Musculoskeletal Disorders 05/2015; 16(1). DOI:10.1186/s12891-015-0592-4 · 1.90 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose High rate of malunion and non union in displaced fracture clavicle treated conservatively lead to use of different types of internal fixation methods which also were found to be associated with various complications. Moreover their superiority over conservative treatment has not been established. This study was designed to compare clinical outcome of conservative treatment with external fixator in cases with displaced midshaft clavicle fractures. Methods Fifty adult consenting cases of acute midshaft fracture clavicle, displaced >15 mm were included. Twenty five cases were allotted to conservative (group A) and external fixator (group B) each. In group A treatment was given in form of clavicle brace. In group B schanz pins were inserted obliquely between supero-inferior and anterior-posterior direction and connected with rod. The outcome was measured by Constant score, union time and complications. Results Mean radiographic union time in group A was 23.45 ± 1.40 weeks (with 8% non union and 80% malunion) and in group B it was 9.36 ± 1.49 weeks. Mean Constant score at 6 months in group A was 78.28 ± 6.45 and in group B 92.72 ± 1.48. Mean shortening at 6 months in group A was 19.36 mm. In group B shortening at 6 months was noticed in three cases (6, 5, 6 mm). Conclusion Close reduction of acute fracture mid clavicle and application of external fixator is a simple procedure providing the benefits of rigid fixation and undisturbed fracture environment. Pain relief is faster, union time is shorter and there are no hardware related problems.
    08/2014; 5(3). DOI:10.1016/j.jcot.2014.07.012
  • [Show abstract] [Hide abstract]
    ABSTRACT: Surgical treatment with open reduction and internal fixation (ORIF) of displaced middle-third clavicular fractures resulted in shorter complete return to work periods with earlier consolidation documented on computed tomography (CT) scans in this prospective, randomized controlled trial. The study randomized 76 consecutive patients with displaced fractures (2B1-2B2 according to Robinson) to conservative (C, n = 42) and surgical (S, n = 34) treatment with plates and screws. Bone union was documented with CT scans at 6 and 12 weeks. Risk factors known to increase the risk of nonunion were similar between groups. Time until discharge for complete return to work was 3.7 ± 1.1 months for C and 2.9 ± 0.8 months for S (P = .003). On the CT scan at 6 weeks, 24.1% of the patients presented advanced bone union in S vs 5.3% in C (P = .05). At 12 weeks, 81% of the patients presented advanced bone union in S vs 16.7% in C (P = .005). At final follow-up, 4 nonunions were present in the C group that required surgery; in the S group, 4 patients underwent revision surgery for plate removal. At 6 and 12 months of follow-up, Constant scores were higher for the S group. Surgical treatment with ORIF of displaced middle-third clavicular fractures achieved good and excellent functional results, shorter time to complete return to work, earlier bone union, and fewer cases of nonunions in a working population under injury compensation. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.
    Journal of shoulder and elbow surgery / American Shoulder and Elbow Surgeons ... [et al.] 01/2015; 24(4). DOI:10.1016/j.jse.2014.11.041 · 2.37 Impact Factor