SPORT Tests Surgery in Spinal Stenosis Patients; Surgery Favored
BY LAUREN UZDIENSKI, FEBRUARY 19, 2008
Data from the eagerly-anticipated final arm of the SPORT trial was released today. Results showed that patients receiving decompressive laminectomy for the treatment of spinal stenosis showed improved outcomes following the procedure.
Prior arms of the $21 million SPORT trial evaluated surgical intervention in spondylolthesis and herniated disc patients. For this arm, patients at 13 U.S. spine clinics were randomized to receive either decompressive surgery or "usual care," which was defined as recommended to include at least active physical therapy, education or counseling with home exercise and NSAIDs. As with previous SPORT data, non-adherence to randomized study groups impacted data analysis.
At two years, of 67% of the 289 patients randomly assigned to decompressive laminectomy had the surgery, and 43% of the 365 assigned to non-surgical care had the surgery. From an intent-to-treat standpoint, patients in the assigned-to-surgery group reported reduced pain scores, though there was no significant difference in their physical function or ODI scores. The authors suggest that in the case of the intent-to-treat analysis, the high rate of non-adherence blunted the benefits of the surgery.
The as-treated analysis combined both cohorts and showed a more significant advantage for surgery. By three months post-op, patients reported less pain and improved function and ODI scores. These changes remained signifcant at two years. Patients who received the "usual care" improved only moderately during the two-year follow-up period.
Overall, patients who received surgery "showed significantly greater improvement in pain, function, satisfaction and self-rated progress than did patients who were treated nonsurgically." The study does have its limits (the lack of a fixed protocol for "usual care," for example), but this study arm and those that preceded support the efficacy spinal surgery for the patients who chose it - in each arm of SPORT, patients evaluated in as-treated analyses reported more significantly improved outcomes.
