Ghogawala 2016.
Methods | Multi‐centre RCT Setting: 5 hospitals Country: USA Period: March 2002 to August 2009 |
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Participants |
Number: 66 patients (35/31) Diagnosis: standardized radiographic and magnetic resonance images Included: patients with grade I lumbar spondylolisthesis (degree of spondylolisthesis: 3 to 14 mm) with lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy Excluded: radiography revealed lumbar instability (motion of > 3 mm at the level of listhesis, as measured on flexion–extension radiographs of the lumbar spine), previous lumbar spinal surgery, severe systemic disease Age (years): mean (SD) 66.5 (8.0)/66.7 (7.2) |
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Interventions |
Group 1: decompression alone by a complete laminectomy with partial removal of the medial facet joint Group 2: decompression plus fusion. Patients in the fusion group underwent a lumbar laminectomy as well as implantation of pedicle screws and titanium alloy rods across the level of listhesis, with a bone graft harvested from the iliac crest Follow‐up: 24 months |
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Outcomes |
Pain: SF‐36 bodily pain subscale Disability: ODI Operation time Perioperative blood loss Reoperations Length of hospital stay |
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Notes |
Surgeon's experience: all surgeons routinely performed both operations tested in the trial; each of the surgeons had performed at
least 100 laminectomies and 100 posterolateral fusions for lumbar spondylolisthesis before joining the trial. Funding: There was no industry funding or any other industry involvement in the trial |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned. |
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 | Low risk | Quote: "independent study coordinator who was not aware of the study hypothesis" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 88% 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 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: "There was no industry funding or any other industry involvement in the SLIP trial." |