A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
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|ClinicalTrials.gov Identifier: NCT01972256|
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : June 4, 2014
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion.
Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
|Condition or disease|
|Pseudoarthrosis Spinal Stenosis Spondylolisthesis Degenerative Disc Disease (DDD)|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Prospective Multicenter Clinical Evaluation of Fusion|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Previous transsacral fusion
Subject candidates are those who had required a transsacral fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Previous transforaminal lumbar interbody fusion
Subject candidates are those who had required transforaminal lumbar interbody fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
- Efficacy [ Time Frame: Assessed at 2 years post-op or greater ]Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.
- Safety [ Time Frame: 2 years post-op ]Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
- Additional Secondary Endpoint: Efficacy [ Time Frame: Assessed at 2 years post-op ]Comparative Lordosis of L4-S1 at 24-months as determined by an independent orthopedic surgeon reviewer's interpretation of 24-month lateral (neutral) radiographs compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972256
|United States, Florida|
|Foundation for Orthopaedic Research and Education|
|Tampa, Florida, United States, 33637|
|United States, Indiana|
|Indiana Spine Group|
|Indianapolis, Indiana, United States, 46032|
|United States, Louisiana|
|Bone and Joint Clinic of Baton Rouge|
|Baton Rouge, Louisiana, United States, 70808|
|United States, Michigan|
|Michigan Spine Institute|
|Waterford, Michigan, United States, 48327|
|United States, Texas|
|College Station, Texas, United States, 77845|