A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
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).
Degenerative Disc Disease (DDD)
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Prospective Multicenter Clinical Evaluation of Fusion|
- Efficacy [ Time Frame: Assessed at 2 years post-op or greater ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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).
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.
|Contact: Rebecca Gibsonfirstname.lastname@example.org|
|United States, California|
|Paquette Spine Institute||Withdrawn|
|Los Angeles, California, United States, 90211|
|United States, Florida|
|Foundation for Orthopaedic Research and Education||Recruiting|
|Tampa, Florida, United States, 33637|
|Contact: Debbi Warren Deborah.Warren@foreonline.org|
|Principal Investigator: James Billys, MD|
|United States, Georgia|
|Chatham Orthopaedics PA||Withdrawn|
|Savannah, Georgia, United States, 31405|
|United States, Indiana|
|Indiana Spine Group||Recruiting|
|Indianapolis, Indiana, United States, 46032|
|Contact: Sheetal Vinayek, M.Sc, CCRP|
|Principal Investigator: Rick Sasso, MD|
|Principal Investigator: Kenneth Renkens, MD|
|United States, Louisiana|
|Bone and Joint Clinic of Baton Rouge||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator: Kevin McCarthy, MD|
|United States, Michigan|
|Michigan Spine Institute||Recruiting|
|Waterford, Michigan, United States, 48327|
|Principal Investigator: Steven M Rapp, MD, FACS|
|United States, Ohio|
|Center for Advanced Spine Technologies||Withdrawn|
|Cincinnati, Ohio, United States, 45242|
|United States, Texas|
|College Station, Texas, United States, 77845|
|Principal Investigator: Mukund Gundanna, MD|
|South Texas Brain and Spine Center||Withdrawn|
|Corpus Christi, Texas, United States, 78404|