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NCT01972256 · ClinicalTrials.gov registry record
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
A clinical trial, sponsored by Baxano Surgical.
- Completed
- Registry status
- 60
- Enrollment target
NCT01972256: Completed study, sponsored by Baxano Surgical.
NCT01972256 is a clinical trial that has completed, run by Baxano Surgical. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01972256 has completed, sponsored by Baxano Surgical.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-02 |
What the finished NCT01972256 record still lists
NCT01972256 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01972256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01972256 about?
NCT01972256 is a clinical study titled "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 fusio...
What is the current status of trial NCT01972256?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2013-04. Estimated completion is 2014-02.
Who is sponsoring clinical trial NCT01972256?
This trial is sponsored by Baxano Surgical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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