A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | April 2013 |
| End Date: | January 2014 |
| Contact: | Rebecca Gibson |
| Email: | rebecca.gibson@baxsurg.com |
Prospective Multicenter Clinical Evaluation of Fusion
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).
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.
procedures at least 2 years prior to the date the data is collected will be evaluated.
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
We found this trial at
9
sites
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