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. 2016 Nov 1;2016(11):CD012421. doi: 10.1002/14651858.CD012421

Bridwell 1993.

Methods Single‐centre RCT
Setting: Barnes‐Jewish Hospital, St. Louis Missouri
Country: USA
Period: February 1985 to March 1990
Participants Number: 44 patients (9/11/24)
Diagnosis: magnetic resonance and computed tomographic imaging. Spinal claudication caused by spinal stenosis at the spondylolisthesis level
Included: no previous spine surgery
Excluded: not reported
Age (years): mean (range) 66.1 (46‐79)
Interventions Group 1: decompression alone. Surgical decompression comprised of laminectomy with preservation of bilateral facet joints without discectomy or extensive foraminotomy
Group 2: decompression plus posterolateral (transverse processes) fusion without instrumentation or posterolateral (facets and transverse processes) fusion with instrumentation. All fusions were performed with autogenous iliac bone graft.
Follow‐up: 37.2 months
Outcomes Disability: Walking ability: worse, same or significantly better after surgery
Complications
Reoperations
Notes Surgeon's experience: not reported
Funding: Conflict of interest and financial support were not reported in this study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "the patients were randomized so that". The authors report an error in the randomisation process.
Allocation concealment (selection bias) Unclear risk Not mentioned.
Blinding of participants (performance bias) 
 All outcomes Unclear risk No mention of any attempts to blind the participants.
Bliding of personnel/ care providers (performance bias) High risk The surgeon could not have been blinded to the intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No mention of any attempts to blind the assessors.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 43/44=97.7% of the patients completed the follow‐up. The number of drop‐outs is unlikely to affect the results.
Intention‐to‐treat analysis (attrition bias) Unclear risk No information about intention‐to‐treat analysis.
Selective reporting (reporting bias) High risk Protocol not available, and relevant outcomes were not reported.
Group similarity at baseline (selection bias) Unclear risk No information about patient characteristics at baseline.
Co‐interventions (performance bias) Unclear risk Only the surgical technique differed between treatment groups. No concomitant discectomy, but foraminotomy was performed in some patients.
Compliance (performance bias) Low risk Compliance in both treatment groups: 100% (surgery).
Timing of outcome assessment (detection bias) Low risk All important outcome assessments for both groups were measured at the same time.
Other bias Unclear risk Conflict of interest not reported. Financial support was not reported in this study.