Hallett 2007.
Methods | Single‐centre RCT Setting: Spinal Unit, Royal Infirmary of Edinburgh, Edinburgh Country: Scotland, UK Period: January 1998 to August 2001 |
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Participants |
Number: 44 patients (14/15/15) Diagnosis: plain radiographs and magnetic resonance images Included: foraminal stenosis; single‐level degenerative disc disease; uni or bilateral leg pain, with or without positive root tension sign, muscle weakness and/or sensory loss; minimum 3 months of conservative care Excluded: spondylolisthesis Grade II or greater; vertebral translocation > 1 cm (instability); disc space narrowing of greater than 50%; serious disease Age (years): mean (range) 57 (34–75) |
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Interventions |
Group 1: decompression (single or bilateral foraminotomy) Group 2: decompression plus instrumented pedicular postero‐lateral fusion Group 3: decompression plus fusion with pedicular screw instrumentation with titanium interbody cages filled with autologous bone. Minimal microdiscectomy was performed if necessary Follow‐up: 60 months |
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Outcomes |
Pain: 10 cm VAS from the Low Back Outcome Score Disability: RMDQ Costs Operation time Perioperative blood loss Reoperations |
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Notes |
Surgeon's experience: All surgery was performed by the same surgeon in a laminar ventilated theatre. Funding: "supported by a grant from DePuy Ltd., U.K. Corporate/Industry funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "type of treatment was randomly allocated immediately before surgery." |
Allocation concealment (selection bias) | Low risk | Quote: "shuffled, closed, opaque envelopes, that were numbered 1 to 150 and opened in sequence." |
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 | High risk | Quote: "the 3 observers were not blinded and any dispute was resolved by discussion." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 93.1% 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: "analysis of the results was by intention to treat." |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported. |
Group similarity at baseline (selection bias) | Unclear risk | No information about patient characteristics at baseline. |
Co‐interventions (performance bias) | Low risk | Only the surgical technique differed between treatment groups. Similar percentage of concomitant discectomy. |
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 | Quote: "supported by a grant from DePuy Ltd., U.K. Corporate/ Industry funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript." |