Clinical Trials Directory

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

TypeNameDescription
PROCEDUREInterbody fusion surgeryInterbody 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.