Treatment of Displaced Midshaft Clavicle Fractures: Figure-of-Eight Harness Versus Anterior Plate Osteosynthesis: A Randomized Controlled Trial.

Background: Most midshaft clavicle fractures affect the economically active population, which is negatively impacted by transient limb impairment during the treatment. There is still debate about the advantages and disadvantages of surgical treatment for these fractures.

Methods: In this prospective randomized controlled trial, 117 patients were allocated to 1 of 2 groups: nonsurgical treatment with a figure-of-eight harness or surgical treatment with anteroinferior plate osteosynthesis. The primary outcome was upper-limb limitation measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 6 months. Other outcomes included pain, radiographic findings, satisfaction with the cosmetic result, complications, and time to return to previous work and activities. Participants were assessed at 6 weeks, 6 months, and 1 year after the intervention.

Results: No difference between the 2 groups was detected in the DASH score at any time point (p = 0.398, 0.403, and 0.877 at 6 weeks, 6 months, and 1 year, respectively), pain levels measured with a visual analogue scale (VAS), time to return to previous activities, or dissatisfaction with the cosmetic result. Seven patients (14.9%) developed nonunion after nonsurgical treatment, a nonunion rate that was significantly higher than that in the surgical group, in which all fractures had healed (p = 0.004). The patients in the nonsurgical group had radiographic evidence of greater clavicle shortening (p < 0.001) and more of the patients in that group answered "yes" when asked if their clavicle felt short (p < 0.001) and if they felt bone prominence (p < 0.001). More patients answered "yes" when asked if they felt paresthesia in the surgical group (7; 13.7%) than in the nonsurgical group (1; 2.1%) (p = 0.036).

Conclusions: This study did not demonstrate a difference in limb function between patients who underwent surgical treatment and those nonsurgically treated for a dislocated midshaft clavicle fracture. Meanwhile, surgical treatment decreased the likelihood of nonunion.

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