Sat., 10/15/11 Recon, UE, Wrist & Hand, Paper #84, 3:47 pm OTA-2011
Δ Improved Outcome Following Primary Operative Fixation of Displaced Midshaft Fractures of the Clavicle Persists at 2 Years Post Injury: Implications for Clinical Treatment, Future Trials, and Economic Analysis
Laura A. Schemitsch; Emil H. Schemitsch, MD; Christian Veillette, MD;
Olivia Y.Y. Cheng, Michael D. McKee, MD;
St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
Background: There is increasing evidence that primary fixation of displaced midshaft fractures of the clavicle results in superior short-term outcomes when compared to traditional nonoperative methods. However, the results from published studies are limited to relatively short-term (1 year or less) follow-up. Accurate data of longer follow-up is important for a number of reasons, including patient prognostication, counseling and care, the design of future trials, and the economic analysis of treatment.
Purpose: The purpose of this study was to examine the results of the 2-year follow-up of patients enrolled in a previously published randomized clinical trial of operative versus nonoperative treatment of displaced fractures of the clavicle.
Methods: Using a comprehensive and standard assessment that included DASH (Disabilities of the Arm, Shoulder and Hand) and CSS (Constant Shoulder Scores) scores, we evaluated 95 patients of the original cohort of 132 patients at 2 years following their injury. We also assessed general health status with the Short Form–36 (SF-36).
Results: Statistical analysis performed on the 2-year follow-up data revealed that DASH and CSS scores remained essentially unchanged at 2 years post injury compared to 1 year post injury for both operative and nonoperative groups (P >0.05). Additionally, outcome scores in the operative group remained superior to the nonoperative group (DASH operative 4 ± 7 versus DASH nonoperative 11 ± 20, P <0.014; CSS operative 97 ± 4 versus CSS nonoperative 92 ± 14, P <0.012) at 2 years after injury. SF-36 scores were also significantly improved in the operative group.
Conclusions: The improvement in outcome seen with primary fixation of displaced clavicle fractures persists at 2 years but does not differ significantly from values seen after 1 year of follow-up, suggesting that clinically a steady state has been reached whereby outcome is unlikely to change with time. This has clinical, economic, and research implications.
Alphabetical Disclosure Listing (628K PDF)
• 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.