Open Reduction and Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures A Multicenter, Randomized, Controlled Trial
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.
- Clinical Orthopaedics and Related Research 05/2014; 472(9). DOI:10.1007/s11999-014-3643-5 · 2.88 Impact Factor
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ABSTRACT: Purpose The aim of this study was to survey existing literature in order to identify all reported predictors associated with nonunion or symptomatic malunion in adult patients with displaced midshaft clavicle fractures treated non-operatively. Method A systematic literature search in Medline was carried out in order to identify publications in English, reporting on predictors for nonunion and malunion in adults with displaced midshaft clavicle fractures. After applying inclusion and exclusion criteria, eight publications were included in this systematic review. Results A total of 2,117 midshaft clavicle fractures were included in the eight publications. All publications reported on predictors for nonunion but none were found to report on predictors for malunion. The studies were characterized by different definitions for nonunion and symptomatic malunion if at all present. A total of 13 potential factors associated with nonunion were identified, six of these (displacement, comminution, shortening, age, gender and smoking) were reported as predictors for nonunion. Outcome definitions varied among the studies. Conclusion The included publications varied greatly in design, sample size, and quality. Based on the present literature most of the predictors were found to be of limited evidence, however displacement seems to be the most likely factor that can be used to predict for nonunion. Treating all clavicle fractures with displacement surgically would inevitably lead to overtreatment, which is why future studies need to focus on predictive factors in order to differentiate between patients that would benefit from surgery and those who would not.International Orthopaedics 07/2014; 38(12). DOI:10.1007/s00264-014-2450-7 · 2.02 Impact Factor
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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