A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
NCT01972256 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60
Last updated 2014-06-04
Summary
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).
Conditions
- Pseudoarthrosis
- Spinal Stenosis
- Spondylolisthesis
- Degenerative Disc Disease (DDD)
Sponsors & Collaborators
-
Baxano Surgical, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2014-02-28
- Completion
- 2014-02-28
Countries
- United States
Study Locations
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