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SPORT trial finds patients with lumbar stenosis more improved after surgery

Patients who did not have surgery had moderate improvement over time, researchers found.

Issue: Issue 2 2008

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The release of data from the third arm of the Spine Patient Outcomes Research Trial (SPORT), showed more patients with lumbar stenosis improved after surgery than without surgery.

“This is the only study I’m aware of where we’ve isolated the different groups of spinal stenosis patients, those with lumbar spinal stenosis and those with spinal stenosis associated with degenerative spondylolisthesis, and I think that’s really important,” said James N. Weinstein, DO, MS, who led the 7-year, US$21 million trial.

Study results, which included 654 patients with lumbar stenosis, were published in the New England Journal of Medicine at the end of February.

All 289 patients in the randomized portion of the study were surgical candidates and reported at least 12 weeks of spinal stenosis symptoms without spondylolisthesis. Of those patients, 67% randomized for surgery and 43% not randomized for surgery were operated on within 2 years of the study’s start.

Procedures were performed at 13 U.S. spine clinics in 11 states.

Investigators also enrolled the remaining 365 patients in SPORT’s observation cohort. At baseline, both study cohorts were “remarkably” similar, investigators said.

Surgery mainly consisted of posterior spinal decompression laminectomy. Those randomized for nonoperative treatment had typical nonsurgical care, such as NSAIDs, physical therapy, or education and counseling coupled with independent exercises.

“We designed the study this way, not to pick one nonoperative treatment, because there isn’t one that has been proven to be better than any other or that’s necessarily better than the natural history,” Weinstein told Orthopaedics Today International.

The intent-to-treat analysis of the study’s randomized portion showed mean SF-36 bodily pain scores improved 7.8% from baseline in those who had surgery — a significant treatment effect, Weinstein said.

There were not many complications of this operation, it seemed not to be risky, and patients did well, he noted.

There were no significant differences between the groups’ SF-36 physical function or Oswestry Disability Index scores at 2 years.

SPORT’s cost-effectiveness results should be available in about 2 months, followed later this year by 4-year results for all study arms, Weinstein said.

For more information:

• James N. Weinstein, DO, MS, chair of the departments of orthopaedics at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School, can be reached at One Medical Center Drive, Lebanon, NH 03756, U.S.A.; +1-603-650-5000; e-mail: james.n.weinstein@dartmouth.edu. The study received research support from various U.S. health organizations.

Reference:

• Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358:794-810.