PAPER 38 THE EFFECT OF A CLAVICLE SHAFT FRACTURE ON GENERAL HEALTH STATUS: RESULTS OF A PROSPECTIVE, RANDOMIZED CLINICAL TRIAL

Abstract

Purpose: In a prospective randomized clinical trial, we have previously reported the “limb-specific” results comparing operative (plate fixation) versus non-operative (sling) treatment for completely displaced fractures of the shaft of the clavicle. We also sought to determine the effect that a fracture of the shaft of the clavicle had on general health status, as measured by the SF-36 General Health Status instrument. We then evaluated the effects of different treatment methods (operative versus non-operative), on general health scores.

Materials: We performed a multi-center, randomized clinical trial of operative versus non-operative treatment of completely displaced clavicular shaft fractures in 111 patients. In addition to radiographic, surgeon-based, and limb-specific data we prospectively gathered SF-36 questionnaires at baseline, and at 6 weeks and 3, 6, 12, and 24 months post-injury.

Results: Both groups had SF-36 scores equivalent to or slightly superior to population norms at baseline. A clavicular shaft fracture had a significant negative effect on SF-36 scores (especially the physical components) in both groups at 6 weeks (p< 0.01) and 3 months (p> < 0.01). There was a statistically greater decrease in Physical Component Scores (PCS) in the non-operative group compared to the operative group (P> < 0.05). At 6 months, scores had returned to pre-operative levels in the operative group, but remained significantly decreased in the non-operative group (p=0.04). This difference persisted at the one and two year points.

Conclusions: A displaced fracture of the clavicular shaft has a clinically significant negative effect on general health status scores. This effect can be mitigated by primary operative fixation, which restores scores to normal levels by six months post-injury. Patients treated non-operatively for a displaced fracture of the shaft of the clavicle demonstrated lower PCS scores at two years post-injury.