The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following: 1. The feasibility of the trial protocol, and 2. Preliminary data on the effectiveness of each treatment.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of patients recruited
Timeframe: 1 year
Number of eligible patients
Timeframe: 1 year
Reasons for refusal to consent
Timeframe: 1 year
Proportion of patients who adhere to randomized allocation
Timeframe: 2 years
Number of patients refusing to consent due to blinding
Timeframe: 1 year
Blinding status
Timeframe: 1.5 months post-surgery
Oswestry Disability Index (ODI)
Timeframe: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
Proportion of patients who receive randomized allocation
Timeframe: 2 years
Number of patients refusing to consent due to randomization
Timeframe: 1 year
Number, type and severity of adverse events
Timeframe: End of hospital stay (average 6.5 days post-surgery)