NCT02348645

Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

Decompression Alone vs. Decompression and Instrumented Fusion for the Management of Lumbar Spinal Stenosis Associated With Stable Degenerative Spondylolisthesis: A Pragmatic Randomized Clinical Pilot Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Stenosis
• Spondylolisthesis

Interventions

Type	Name	Description
PROCEDURE	Spinal fusion
PROCEDURE	Spinal decompression

Timeline

• Start date: 2015-07-01
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2015-01-28
• Last updated: 2022-11-09

Locations

8 sites across 1 country: Canada