Bridwell 1993.
Methods | Single‐centre RCT Setting: Barnes‐Jewish Hospital, St. Louis Missouri Country: USA Period: February 1985 to March 1990 |
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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) |
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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 |
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Outcomes |
Disability: Walking ability: worse, same or significantly better after surgery Complications Reoperations |
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Notes |
Surgeon's experience: not reported Funding: Conflict of interest and financial support were not reported in this study. |
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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. |