Skip to main content
. 2016 Nov 1;2016(11):CD012421. doi: 10.1002/14651858.CD012421

Grob 1995.

Methods Single‐centre RCT
Setting: Schutthess Hospital, Zurich
Country: Switzerland
Period: November 1989 to November 1990
Participants Number: 45 patients (15/15/15)
Diagnosis: history and clinical examination; CT and MRI (mid‐sagittal diameter of the spinal canal of less than 11 mm)
Included: degenerative spinal stenosis
Excluded: systemic disease; instability of the spine; previous operation
Age (years): mean (range) 67 (48‐87)
Lumbar stenosis duration (years): mean (range) 1.3 (0.5‐3.1)
Interventions Group 1: decompression alone. Decompression involved widening of the lateral recess, undercut of lamina, and discectomy or foraminotomy in some patients
Group 2: decompression plus arthrodesis of the most stenotic segment
Group 3: decompression plus arthrodesis of all of the decompressed vertebral segments
Follow‐up: 28 months
Outcomes Pain: 10 cm VAS overall pain
Disability: walking ability
Operation time
Perioperative blood loss:
Complications
Reoperations
Notes Surgeon's experience: All the operations were performed by the same surgeon
Funding: "no funds were received in support to this study"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the patients were randomly assigned to the three treatment 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 100% of the patients completed the follow‐up.
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) Unclear risk No information about patients characteristics at baseline.
Co‐interventions (performance bias) Low risk Only the surgical technique differed between treatment groups. Similar percentage of concomitant discectomy. All participants received the same postoperative care.
Compliance (performance bias) Low risk Compliance in both treatment groups: 100% (surgery).
Timing of outcome assessment (detection bias) High risk Patients were assessed at different time points. The average duration of follow‐up was 38 months (range: 24 to 32).
Other bias Low risk Quote: "no funds were received in support to this study"