Liu 2013.
Methods | Single‐centre RCT Setting: Department of Orthopedic Surgery, Qilu Hospital of Shandong University, Jinan, Shandong Country: China Period: not reported |
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Participants |
Number: 56 patients (27/29) Diagnosis: lumbar spinal stenosis diagnosis by an experienced spine specialist Included: patients with lumbar spinal stenosis without degenerative spondylolisthesis or interbody instability Excluded: not reported Age (years): mean (SD) 59.4 (4.7)/61.1 (3.1) Lumbar stenosis duration (years): mean (range) 6.5/5.9 (0.6‐13) |
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Interventions |
Group 1: conventional laminectomy Group 2: spinous process‐splitting unilateral laminotomy. The spinous process and the interspinous ligaments were split longitudinally, preserving the paraspinal muscles. Then unilateral laminotomy was conducted for bilateral decompression with removal of the cranial and the caudal portion of the ipsilateral lamina, ligamentum flavum, and medial part of the facet Follow‐up: 24 months |
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Outcomes |
Pain: 10 cm VAS leg pain Disability: JOA Operation time Perioperative blood loss |
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Notes |
Surgeon's experience: all patients were diagnosed and assessed by experienced spine specialists Funding: "no funds were received in support of this work. No relevant financial activities outside the submitted work" |
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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 categorized into 2 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 | 54/57=94.7% 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) | 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 1 and 2. |
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. No relevant financial activities outside the submitted work." |