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NCT05701046
Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis
Conditions: Isthmic Spondylolisthesis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 489
Sponsor: University of British Columbia
Location: Canada
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.
Eligibility Criteria
Inclusion Criteria:Male or female aged 18 years or older (or who have reached the age of majority in the participating province)Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.Are able to communicate in English or FrenchAnterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw constructPosterior interbody fusion group will have only posterior approach procedure.Exclusion Criteria:Previous spinal surgerySpecific pathology at level above and below:Degenerative anterolisthesisPars defect above or below index level
Source: ClinicalTrials.gov (NCT05701046). StuddyBuddy aggregates publicly available trial information.