Paper snapshot
Rapid study overview
DOI
10.1056/NEJMoa070302
PMID
17538085
PICO
Population
Surgical candidates with degenerative spondylolisthesis and spinal stenosis from 13 centers in 11 U.S. states, with at least 12 weeks of symptoms and image confirmation.
Intervention
Standard decompressive laminectomy (with or without fusion).
Comparator
Usual nonsurgical care (e.g., physical therapy, analgesics).
Outcomes
SF-36 bodily pain and physical function scores (100-point scales), modified Oswestry Disability Index (100-point scale) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Design
Type
Randomized controlled trial with an observational cohort.
Randomized
Yes
Multicenter
Yes
Blinded
Not applicable: outcomes were patient-reported and not blinded.
Follow-up
2 years.
Primary endpoint
SF-36 bodily pain and physical function scores and modified Oswestry Disability Index at 2 years.
Secondary endpoints
- Treatment effects at 3 months, 6 months, and 1 year.
- Crossover rates between treatment groups.