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Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

NCT05701046 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 489

Last updated 2024-05-09

No results posted yet for this study

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

  • Isthmic Spondylolisthesis

Interventions

PROCEDURE

Interbody fusion surgery

Interbody fusion surgery

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2028-02-15
Completion
2038-02-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701046 on ClinicalTrials.gov