Lonne 2015.
Methods | Multi‐centre RCT Setting: 6 different Norwegian hospitals Country: Norway Period: June 2007 to September 2011 |
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Participants |
Number: 96 patients (49/47) Diagnosis: symptoms of neurogenic intermittent claudication and magnetic resonance images and radiographs Included: patients with 1 or 2 stenotic levels (from L2 to L5) and with minor spondylolisthesis (Meyerding, grade 1) Excluded: spinal stenosis at more than 2 levels; previous low back surgery; unilateral radiculopathy; severe paresis; cauda equina syndrome; degenerative spondylolisthesis > grade 1; isthmic spondylolisthesis; severe scoliosis, idiopathic or degenerative (Cobb angle > 10° or sagittally imbalanced); osteoporosis or suspected osteoporotic fractures in lumbar spine; symptomatic coxarthrosis; vascular intermittent claudication; polyneuropathy; malignant disease Age (years): mean (SD) 67 (8.7)/67 (8.8) BMI (kg/m²): mean (SD) 28 (3.8)/28 (4.7) Lumbar stenosis duration (years): more than 2 years for the majority of patients in both groups |
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Interventions |
Group 1: minimally invasive decompression (bilateral laminotomy). Decompression was performed by a partial excision of the lower part of the lamina and the medial aspects of the facet joint. Group 2: interspinous process spacer device (X‐Stop). The X‐Stop was inserted between the spinous processes through the interspinous ligament and was secured by the supraspinous ligament posteriorly and by the lamina anteriorly Follow‐up: 24 months |
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Outcomes |
Pain: 11‐point numerical rating scale leg pain Disability: ODI Quality of life: EQ‐5D Costs Operation time Perioperative blood loss Complications Reoperations Length of hospital stay |
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Notes |
Surgeon's experience: not reported Funding: "the study was supported by non‐commercial organisations (South‐East Regional Health Authority, Norway and the National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Norway)" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomized with randomly selected block sizes by a computer‐based web solution." |
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 | 81/96 = 84% of the patients completed the follow‐up. The number of drop‐outs was similar in each group and the reasons for drop‐out are also reported and are unlikely to affect the results. |
Intention‐to‐treat analysis (attrition bias) | Low risk | Quote: "in the main evaluation, not only was an intention‐to‐treat analysis 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 Tables 2 and 4. |
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: "the study was supported by non‐commercial organisations (South‐East Regional Health Authority, Norway and the National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Norway)." |