Grob 1995.
Methods | Single‐centre RCT Setting: Schutthess Hospital, Zurich Country: Switzerland Period: November 1989 to November 1990 |
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Participants |
Number: 45 patients (15/15/15) Diagnosis: history and clinical examination; CT and MRI (mid‐sagittal diameter of the spinal canal of less than 11 mm) Included: degenerative spinal stenosis Excluded: systemic disease; instability of the spine; previous operation Age (years): mean (range) 67 (48‐87) Lumbar stenosis duration (years): mean (range) 1.3 (0.5‐3.1) |
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Interventions |
Group 1: decompression alone. Decompression involved widening of the lateral recess, undercut of lamina, and discectomy or foraminotomy in some patients Group 2: decompression plus arthrodesis of the most stenotic segment Group 3: decompression plus arthrodesis of all of the decompressed vertebral segments Follow‐up: 28 months |
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Outcomes |
Pain: 10 cm VAS overall pain Disability: walking ability Operation time Perioperative blood loss: Complications Reoperations |
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Notes |
Surgeon's experience: All the operations were performed by the same surgeon Funding: "no funds were received in support to this study" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the patients were randomly assigned to the three treatment groups." |
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 | 100% of the patients completed the follow‐up. |
Intention‐to‐treat analysis (attrition bias) | Unclear risk | No information about intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported. |
Group similarity at baseline (selection bias) | Unclear risk | No information about patients characteristics at baseline. |
Co‐interventions (performance bias) | Low risk | Only the surgical technique differed between treatment groups. Similar percentage of concomitant discectomy. All participants received the same postoperative care. |
Compliance (performance bias) | Low risk | Compliance in both treatment groups: 100% (surgery). |
Timing of outcome assessment (detection bias) | High risk | Patients were assessed at different time points. The average duration of follow‐up was 38 months (range: 24 to 32). |
Other bias | Low risk | Quote: "no funds were received in support to this study" |