Operative versus nonoperative interventions for common fractures of the clavicle: a meta-analysis of randomized controlled trials

Abstract

Background: The popularity of surgery for acute displaced midshaft clavicle fractures has been fuelled by early randomized controlled trials (RCTs) showing improved rates of radiographic union and perceived functional benefits compared with nonoperative approaches. We performed a meta-analysis to determine the effect of operative and nonoperative interventions on the risk of secondary operation and complications and on long-term function.

Methods: We search MEDLINE, Embase and the Cochrane Central Register of Controlled Trials for reports of relevant RCTs published to Mar. 7, 2014. Two reviewers assessed eligibility of potential reports and the risk of bias of included trials. The Grading of Recommendations Assessment, Development and Evaluation approach was used to summarize the quality of evidence for all outcomes.

Results: We included 15 RCTs (9 trials comparing operative and nonoperative interventions, 5 comparing implants for operative treatment, and 1 comparing nonoperative treatments). Nonoperative treatments did not differ from operative treatments in the risk of secondary operation (risk ratio [RR] 1.16, 95% confidence interval [CI] 0.58 to 2.35) or all complications (RR 0.90, 95% CI 0.55 to 1.50). One in 4 patients had a complication regardless of the treatment approach. Differences in functional outcomes, although smaller than the threshold for minimal important differences at 1 year, favoured operative interventions (standardized mean difference 0.38, 95% CI 0 to 0.75). Evidence for the type of implant or approach to nonoperative treatment remained inconclusive.

Interpretation: Current evidence does not support the routine use of internal fixation for the treatment of displaced midshaft clavicle fractures. Complication rates were high regardless of the treatment approach.

Conflict of interest statement

Competing interests: Mohit Bhandari has received consultancy fees from Smith & Nephew, Stryker, Amgen, Zimmer, Moximed, Bioventus, Merck, Eli Lilly and Sanofi; he was involved in research funded by Smith & Nephew, DePuy, Eli Lilly, Bioventus, Stryker, Zimmer and Amgen. No other competing interests were declared.

Figures

Figure 1

Selection of studies for the meta-analysis.

Figure 2

Risk-of-bias assessment of randomized controlled trials included in the meta-analysis. COTS = Canadian Orthopaedic Trauma Society.

Figure 3

Funnel plot, to assess whether there is evidence of publication bias among trials of operative versus nonoperative treatment of acute displaced midshaft clavicle fractures. The standard normal deviate of the SMD (natural logarithm of the SMD divided by its standard error [SE]) is plotted against the estimate's precision (inverse of the SE). SMD = standardized mean difference.

Figure 4

Pooled estimates of secondary operation between operative and nonoperative groups. Values less than 1.0 favour operative treatment. Note: The N values in the study by Figueiredo et al. (24 operative, 16 nonoperative) are the numbers who completed the study and not the numbers initially randomized. CI = confidence interval.

Figure 5

Pooled estimates of all complications between operative and nonoperative groups. Values less than 1.0 favour operative treatment. Note: The N values in the study by Figueiredo et al. (24 operative, 16 nonoperative) are the numbers who completed the study and not the numbers initially randomized. CI = confidence interval.

Figure 6

Pooled long-term function (≥ 1 yr) following operative and nonoperative treatment. Standardized mean differences (SMDs) greater than zero favour operative treatment. Red lines show a zone of clinical equivalence based on a minimal important difference of 10.2 points on the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. CI = confidence interval, SD = standard deviation.