A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prospective Multicenter Clinical Evaluation of Fusion

Conditions
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Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18 years of age or older Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD) Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery Exclusion Criteria: Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1 Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previous transsacral fusion<br>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<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |