Randomized trial and concurrent observational cohort study.
To compare 4 year outcomes of surgery to nonoperative care for spinal stenosis.
Surgery for spinal stenosis has been shown to be more effective compared to nonoperative treatment over 2 years, but longer-term data have not been analyzed.
Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort (RC) or observational cohort (OC). Treatment was standard decompressive laminectomy or standard nonoperative care. Primary outcomes were SF-36 bodily pain (BP) and physical function scales and the modified Oswestry Disability index assessed at 6 weeks, 3 months, 6 months, and yearly up to 4 years.
A total of 289 patients enrolled in the RC and 365 patients enrolled in the OC. An as-treated analysis combining the RC and OC and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years, with treatment effects (defined as mean change in surgery group minus mean change in nonoperative group) for bodily pain 12.6 (95% confidence interval [CI], 8.5–16.7); physical function 8.6 (95% CI, 4.6–12.6); and Oswestry Disability index −9.4 (95% CI, −12.6 to −6.2). Early advantages for surgical treatment for secondary measures such as bothersomeness, satisfaction with symptoms, and self-rated progress were also maintained.
Patients with symptomatic spinal stenosis treated surgically compared to those treated nonoperatively maintain substantially greater improvement in pain and function through 4 years.
Four-year outcomes for the Spine Patient Outcomes Research Trial spinal stenosis surgical and nonoperative cohorts are reported. Overall, 419 patients received surgery at some point during the first 4 years; 235 remained nonoperative. The proportion of enrollees who supplied data at each follow-up visit interval ranged from 67% to 89% with losses due to dropouts, missed visits, or deaths. The as-treated analysis combining the randomized and observational cohorts and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years.
From the *Department of Orthopaedics, Dartmouth Medical School, Hanover, NH; †The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH; ‡Dartmouth-Hitchcock Medical Center, Lebanon, NH; §Department of Orthopaedic Surgery, William H. Beaumont Hospital, Royal Oak, MI; ¶Hospital for Joint Diseases, New York, NY; ∥Department of Orthopaedic Surgery, Rothman Institute at Thomas Jefferson University, Philadelphia, PA; **Emory Spine Center, Emory University, Atlanta, GA; ††Kaiser-Permanente, San Francisco, CA; ‡‡Department of Orthopaedic Surgery, University of California, San Francisco, CA; and §§Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL.
Acknowledgment date: June 26, 2009. First revision date: September 25, 2009. Acceptance date: January 11, 2010.
The manuscript submitted does not contain information about medical device(s)/drug(s).
Federal funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis; #NCT00000411; available at: http://www.clinicaltrials.gov/.
Supported by The National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01-AR45444) and the Office of Research on Women's Health, the National Institutes of Health, and the National Institute of Occupational Safety and Health, the Centers for Disease Control and Prevention.
Address correspondence and reprint requests to James N. Weinstein, DO, MS, Department of Orthopaedics, The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth Medical School, One Medical Center Dr. Lebanon, NH 03756; E-mail: SPORT@dartmouth.edu