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Randomized Controlled Trial
. 2018 Dec 1;43(23):1619-1630.
doi: 10.1097/BRS.0000000000002682.

Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT)

William A Abdu  1   2 , Olivia A Sacks  1 , Anna N A Tosteson  1   3   4 , Wenyan Zhao  1   2 , Tor D Tosteson  1   4 , Tamara S Morgan  1   4 , Adam Pearson  1   2 , James N Weinstein  2   4 , Jon D Lurie  1   3   4
Affiliations
Randomized Controlled Trial

Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT)

William A Abdu et al. Spine (Phila Pa 1976). .

Abstract

Study design: Randomized trial with a concurrent observational cohort study.

Objective: To compare 8-year outcomes between surgery and nonoperative care and among different fusion techniques for symptomatic lumbar degenerative spondylolisthesis (DS).

Summary of background data: Surgical treatment of DS has been shown to be more effective than nonoperative treatment out to 4 years. This study sought to further determine the long-term (8-year) outcomes.

Methods: Surgical candidates with DS from 13 centers with at least 12 weeks of symptoms and confirmatory imaging were offered enrollment in a randomized controlled trial (RCT) or observational cohort study (OBS). Treatment consisted of standard decompressive laminectomy (with or without fusion) versus standard 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 6 weeks, 3 months, 6 months, and yearly up to 8 years.

Results: Data were obtained for 69% of the randomized cohort and 57% of the observational cohort at the 8-year follow up. Intent-to-treat analyses of the randomized group were limited by high levels of nonadherence to the randomized treatment. As-treated analyses in the randomized and observational groups showed significantly greater improvement in the surgery group on all primary outcome measures at all time points through 8 years. Outcomes were similar among patients treated with uninstrumented posterolateral fusion, instrumented posterolateral fusion, and 360° fusion.

Conclusion: For patients with symptomatic DS, patients who received surgery had significantly greater improvements in pain and function compared with nonoperative treatment through 8 years of follow-up. Fusion technique did not affect outcomes.

Level of evidence: 1.

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Figures

Figure 1
Figure 1
Exclusion, Enrollment, Randomization and Follow-up of Trial Participants. The values for surgery, withdrawal, and death are cumulative over eight years. For example, a total of 8 patients died during the follow-up period. [Data set 09/03/13]
Figure 2
Figure 2
Main outcomes surgery vs. non-operative combined cohort
Figure 3
Figure 3
Outcomes for different fusion techniques
See this image and copyright information in PMC

Comment in

References

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