Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis
NCT ID: NCT05701046
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
489 participants
OBSERVATIONAL
2023-01-05
2038-02-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone)
Interbody fusion surgery
Interbody fusion surgery
Posterior interbody fusion (TLIF or PLIF) (open or MIS)
Interbody fusion surgery
Interbody fusion surgery
Interventions
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Interbody fusion surgery
Interbody fusion surgery
Eligibility Criteria
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Inclusion Criteria
* 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 French
* Anterior 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 construct
* Posterior interbody fusion group will have only posterior approach procedure.
Exclusion Criteria
* Specific pathology at level above and below:
* Degenerative anterolisthesis
* Pars defect above or below index level
18 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Charlotte Dandurand
Spinal Neurosurgeon
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H22-00699
Identifier Type: -
Identifier Source: org_study_id
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