Trials / Recruiting
RecruitingNCT05701046
Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis
Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 489 (estimated)
- Sponsor
- University of British Columbia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available. This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Interbody fusion surgery | Interbody fusion surgery |
Timeline
- Start date
- 2023-01-05
- Primary completion
- 2028-02-15
- Completion
- 2038-02-15
- First posted
- 2023-01-27
- Last updated
- 2024-05-09
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05701046. Inclusion in this directory is not an endorsement.