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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at 2 years post-op or greater |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Secondary Endpoint: Efficacy | 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. | Assessed at 2 years post-op |
Inclusion Criteria:
Exclusion Criteria:
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Subject candidates are those who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33637 | United States | ||
| Indiana Spine Group |
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| ID | Term |
|---|---|
| D011542 | Pseudarthrosis |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D005599 | Fractures, Ununited |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013122 | Spinal Diseases |
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| Indianapolis |
| Indiana |
| 46032 |
| United States |
| Bone and Joint Clinic of Baton Rouge | Baton Rouge | Louisiana | 70808 | United States |
| Michigan Spine Institute | Waterford | Michigan | 48327 | United States |
| Brazos Spine | College Station | Texas | 77845 | United States |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |