Background: The aim was to analyze whether patients with a displaced midshaft clavicular fracture are best managed with plate fixation or nonoperative treatment with respect to nonunion, secondary operations, and functional outcome, by evaluating all available randomized controlled trials (RCTs) on this subject.
Methods: A systematic search of electronic databases (PubMed, MEDLINE, Embase, and Web of Science) was performed to identify RCTs comparing nonoperative treatment with plate fixation for displaced midshaft clavicular fractures. Risk of bias of the studies was assessed. Outcomes evaluated were nonunion, shoulder function (Constant score and Disabilities of the Arm, Shoulder and Hand [DASH] score), and secondary operations.
Results: Six RCTs (614 patients) were included. The risk of nonunion was lower in the operatively treated patients (relative risk [RR] = 0.14, 95% confidence interval [CI] = 0.06 to 0.32). One-third of the patients with a nonunion did not receive further treatment. Secondary operations for adverse events were performed less often in the operatively treated patients (RR = 0.42, 95% CI = 0.25 to 0.71). When plate removal operations were also included, a secondary operation was performed in 17.6% in the operative group and 16.6% in the nonoperative group (RR = 1.01, 95% CI = 0.64 to 1.59). Constant and DASH scores after 1 year were somewhat better after plate fixation, with mean differences of 4.4 points (95% CI, 0.9 to 7.9 points) and 5.1 points (95% CI, 0.1 to 10.1 points), respectively.
Conclusions: Plate fixation significantly reduces the risk of nonunion, but does not have a clinically relevant advantage regarding final functional outcome. Secondary operations are common after both treatments. Overall, there is not enough evidence to support routine operative treatment for all patients with a displaced midshaft clavicular fracture.
Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.