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).
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.
Study Type
OBSERVATIONAL
Enrollment
60
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States
Indiana Spine Group
Indianapolis, Indiana, United States
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, United States
Michigan Spine Institute
Waterford, Michigan, United States
Brazos Spine
College Station, Texas, United States
Efficacy
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.
Time frame: Assessed at 2 years post-op or greater
Safety
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.
Time frame: 2 years post-op
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