OTA 2008 Posters

Scientific Poster #130 Upper Extremity OTA-2008

The Effect of a Clavicle Shaft Fracture on General Health Status: Results of a Prospective, Randomized Clinical Trial

Michael D. McKee, MD (a-Zimmer; b-Biotech; b,e-Stryker); Charles Thompson, MD (n);
Lynn Vicente, MD (n); Lisa Wild, RN (n); Emil H. Schemitsch, MD (a-Biomimetic, Synthes,
Zimmer; a,b-Smith + Nephew; a,b,e-Stryker; e-Pfizer);
St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

Purpose: In a prospective, randomized clinical trial, we have previously reported the “limbspecific” results comparing operative (plate fixation) versus nonoperative (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 Short Form-36 (SF-36) general health status instrument. We then evaluated the effects of different treatment methods (operative versus nonoperative) on general health scores.

Methods: We performed a multicenter, randomized clinical trial of operative versus nonoperative 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 postinjury.

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 in the nonoperative group compared to the operative group (P <0.05). At 6 months, scores had returned to preoperative levels in the operative group, but remained significantly decreased in the nonoperative group (P = 0.04). This difference persisted at the 1- and 2-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 6 months postinjury. Patients treated nonoperatively for a displaced fracture of the shaft of the clavicle demonstrated lower physical component scores at 2 years postinjury.

Significance: This information is useful in counseling patients with regard to treatment options following displaced fractures of the clavicle shaft.

If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant.