Weinstein and colleagues tested whether decompressive surgery, with fusion or without, improves pain and function more than nonsurgical care in degenerative spondylolisthesis with stenosis.
Randomized cohort of 304 and observational cohort of 303 surgical candidates at 13 US centers, followed 2 years.
Methods
Design
Randomized cohort plus observational cohort
Setting
13 US centers across 11 states
Patients
607 surgical candidates
304 randomized
303 observational
Symptoms ≥ 12 weeks
Image‑confirmed degenerative spondylolisthesis
Groups
Decompressive laminectomy with or without fusion
Usual nonsurgical care
Follow-up
6 weeks, 3 months, 6 months, 1 year and 2 years
Primary outcome
SF‑36 bodily pain
SF‑36 physical function
Modified Oswestry Disability Index
Outcomes
Surgical complications
Reoperation at 2 years
Key Findings
Analyzed by assigned group, the randomized cohort showed no significant surgical advantage on any primary outcome.
About 40% of randomized patients crossed over in each direction by 1 year, vs 17% to surgery and 3% to nonsurgical care in the observational cohort.
Analyzed by treatment received across both cohorts, surgery's advantage was significant by 3 months, grew by 1 year and fell only a little by 2 years.
In that as‑treated comparison, Oswestry disability fell 16.7 points more with surgery at 2 years (95% CI −19.5 to −13.9).
Dural tear or CSF leak was the most common surgical complication, at 10%.
Reoperation was needed in 12% of surgical patients by 2 years.
Board pearl
SPORT's surgical advantage in degenerative spondylolisthesis comes from nonrandomized as‑treated comparisons, because the intention‑to‑treat analysis, diluted by heavy two‑way crossover, found no significant difference.
Authors' conclusion
In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically.
Weinstein and colleagues tested whether decompressive surgery, with fusion or without, improves pain and function more than nonsurgical care in degenerative spondylolisthesis with stenosis.
Randomized cohort of 304 and observational cohort of 303 surgical candidates at 13 US centers, followed 2 years.
Methods
Design
Randomized cohort plus observational cohort
Setting
13 US centers across 11 states
Patients
607 surgical candidates
304 randomized
303 observational
Symptoms ≥ 12 weeks
Image‑confirmed degenerative spondylolisthesis
Groups
Decompressive laminectomy with or without fusion
Usual nonsurgical care
Follow-up
6 weeks, 3 months, 6 months, 1 year and 2 years
Primary outcome
SF‑36 bodily pain
SF‑36 physical function
Modified Oswestry Disability Index
Outcomes
Surgical complications
Reoperation at 2 years
Key Findings
Analyzed by assigned group, the randomized cohort showed no significant surgical advantage on any primary outcome.
About 40% of randomized patients crossed over in each direction by 1 year, vs 17% to surgery and 3% to nonsurgical care in the observational cohort.
Analyzed by treatment received across both cohorts, surgery's advantage was significant by 3 months, grew by 1 year and fell only a little by 2 years.
In that as‑treated comparison, Oswestry disability fell 16.7 points more with surgery at 2 years (95% CI −19.5 to −13.9).
Dural tear or CSF leak was the most common surgical complication, at 10%.
Reoperation was needed in 12% of surgical patients by 2 years.
Board pearl
SPORT's surgical advantage in degenerative spondylolisthesis comes from nonrandomized as‑treated comparisons, because the intention‑to‑treat analysis, diluted by heavy two‑way crossover, found no significant difference.
Authors' conclusion
In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically.