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. 2016 Nov 1;2016(11):CD012421. doi: 10.1002/14651858.CD012421

Hallett 2007.

Methods Single‐centre RCT
Setting: Spinal Unit, Royal Infirmary of Edinburgh, Edinburgh
Country: Scotland, UK
Period: January 1998 to August 2001
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)
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
Outcomes Pain: 10 cm VAS from the Low Back Outcome Score
Disability: RMDQ
Costs
Operation time
Perioperative blood loss
Reoperations
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"
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."