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Surgical Compared with Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis

Four-Year Results in the Spine Patient Outcomes Research Trial (SPORT) Randomized and Observational Cohorts

¹ Departments of Orthopaedics (J.N.W., W.Z., and E.A.B.), Medicine (J.D.L. and A.N.A.T.), and Community and Family Medicine (T.D.T. and A.N.A.T.), Dartmouth Medical School, One Medical Center Drive, Lebanon, NH 03756. E-mail address for J.N. Weinstein: SPORT{at}dartmouth.edu
² University of Michigan Health System, 2101 Taubman Center, 1500 East Medical Center Drive, Ann Arbor, MI 48109-0346
³ Department of Orthopaedic Surgery, William Beaumont Hospital, 3535 West 13 Mile Road, #744, Royal Oak, MI 48073
⁴ Nebraska Foundation for Spinal Research, 11819 Miracle Hills Drive, Suite 102, Omaha, NE 68154
⁵ Department of Orthopaedic Surgery, Washington University School of Medicine, One Barnes-Jewish Hospital Plaza, Suite 11300 West Pavilion, St. Louis, MO 63110
⁶ Department of Orthopaedics, West Virginia University, 3700 Robert C. Byrd Health Science Center South, Morgantown, WV 26506
⁷ University of California Medical Center, 400 Parnassus Avenue, Third Floor, San Francisco, CA 94143

Investigation performed at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, William Beaumont Hospital, Royal Oak, Michigan, Nebraska Foundation for Spinal Research, Omaha, Nebraska, Washington University, St. Louis, Missouri, Case Western Reserve/University Hospitals of Cleveland, Cleveland, Ohio, University of California, San Francisco, California, Emory University, Atlanta, Georgia, Hospital for Joint Diseases, New York, NY, The Hospital for Special Surgery, New York, NY, Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania, Kaiser-Permanente, Oakland, California, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, and Maine Spine and Rehabilitation, Scarborough, Maine

Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases 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. In addition, one or more of the authors or a member of his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Medtronic). Also, a commercial entity (Medtronic) paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.

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Methods: Surgical candidates from thirteen centers with symptoms of at least twelve weeks' duration as well as confirmatory imaging showing degenerative spondylolisthesis with spinal stenosis were offered enrollment in a randomized cohort or observational cohort. Treatment consisted of standard decompressive laminectomy (with or without fusion) or usual nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at six weeks, three months, six months, and yearly up to four years.

Results: In the randomized cohort (304 patients enrolled), 66% of those randomized to receive surgery received it by four years whereas 54% of those randomized to receive nonoperative care received surgery by four years. In the observational cohort (303 patients enrolled), 97% of those who chose surgery received it whereas 33% of those who chose nonoperative care eventually received surgery. The intent-to-treat analysis of the randomized cohort, which was limited by nonadherence to the assigned treatment, showed no significant differences in treatment outcomes between the operative and nonoperative groups at three or four years. An as-treated analysis combining the randomized and observational cohorts that adjusted for potential confounders demonstrated that the clinically relevant advantages of surgery that had been previously reported through two years were maintained at four years, with treatment effects of 15.3 (95% confidence interval, 11 to 19.7) for bodily pain, 18.9 (95% confidence interval, 14.8 to 23) for physical function, and –14.3 (95% confidence interval, –17.5 to –11.1) for the Oswestry Disability Index. Early advantages (at two years) of surgical treatment in terms of the secondary measures of bothersomeness of back and leg symptoms, overall satisfaction with current symptoms, and self-rated progress were also maintained at four years.

Conclusions: Compared with patients who are treated nonoperatively, patients in whom degenerative spondylolisthesis and associated spinal stenosis are treated surgically maintain substantially greater pain relief and improvement in function for four years.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

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