Stromqvist 2013.
Methods | Multi‐centre RCT Setting: 3 Swedish spine centres Country: Sweden Period: not reported |
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Participants |
Number: 100 patients (50/50) Diagnosis: MRI verified spinal stenosis on 1 or 2 levels in the lumbar spine Included: symptoms of neurogenic claudication for minimum 6 months elicited by walking and relieved by flexion of the spine or sitting down; age 40 years or more was required; spinal stenosis was allowed to be present at maximum 2 levels and minor spondylolisthesis (Meyerding, grade 1) was accepted Excluded: Previous spine surgery (except for successful disc surgery); infection or malignant disorder; osteoporosis diagnosed before referral for surgery and subjected to medical treatment; stenosis of the L5–S1‐level due to the small spinous process of S1 Age (years): mean (range) 69 (49‐89) |
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Interventions |
Group 1: decompression alone. The decompressive procedures were performed using laminectomy or laminotomies with facet‐joint sparing techniques Group 2: interspinous process spacer device (X‐Stop) All operations included open procedures Follow‐up: 24 months |
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Outcomes |
Pain: 100 mm VAS leg pain Disability: ZCQ (physical function) Operation time Complications Reoperations |
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Notes |
Surgeon's experience: not reported Funding: "no funds were received in support of this work" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomization was performed by using envelopes." |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomization was performed by using envelopes." |
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 | 96/100 = 96% of the patients completed the follow‐up. The number of drop‐outs is unlikely to affect the results. |
Intention‐to‐treat analysis (attrition bias) | Low risk | Quote: "in the main evaluation, not only was intention‐to‐treat analysis used, but also as‐treated analysis was performed." |
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 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 | Low risk | Quote: "no funds were received in support of this work." |