Thome 2005.
Methods | Single‐centre RCT Setting: Departments of Neurosurgery, Neurology, and Neuroradiology, University Hospital Mannheim Country: Germany Period: not reported |
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Participants |
Number: 120 patients (40/40/40) Diagnosis: Radiological/neuroimaging evidence of lumbar stenosis Included: symptoms of neurogenic claudication or radiculopathy; radiological/neuroimaging evidence of degenerative lumbar stenosis; absence of associated pathological entities such as disc herniations or instability; no history of surgery for lumbar stenosis or lumbar fusion Excluded: patients who required discectomy Age (years): mean (range) 68 (44‐86) BMI (kg/m²): mean (SD) 28 (4)/29 (6)/29 (4) Lumbar stenosis duration (years): mean (SD) 1.7 (2.5) |
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Interventions |
Group 1: laminectomy Group 2: unilateral laminotomy Group 3: bilateral laminotomy An operating microscope and high‐speed burrs and Kerrison rongeurs were used in all procedures. Special care was taken in all three groups to minimize facet joint resection by using an undercutting technique Follow‐up: 12 months |
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Outcomes |
Pain: 10 cm VAS overall pain Disability: RMDQ Operation time Perioperative blood loss 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) | Low risk | Quote: "computer‐generated randomization list was used to assign the patient to one of the 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 | 110/120=91.6% 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) | Low risk | All expected outcomes were reported. |
Group similarity at baseline (selection bias) | Low risk | Patients did not differ in their baseline characteristics, based on the Table 1. |
Co‐interventions (performance bias) | Low risk | Only the surgical technique differed between treatment groups. |
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. |