XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | November 2009 |
End Date: | December 2014 |
A Prospective Multi-Center Randomized Evaluation of the Clinical and Radiographic Outcomes of XLIF® Compared With MAS® TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis
The purpose of this study is to determine differences in the XLIF and TLIF procedures with
respect to perioperative variables in adult patients with low-grade symptomatic
spondylolisthesis.
The study is a prospective multi-center randomized evaluation of clinical and radiographic
outcomes of two commonly used lumbar interbody fusion procedures (XLIF and TLIF) in adult
patients with low-grade symptomatic spondylolisthesis. The study seeks to identify
differences between the procedures with respect to perioperative variables.
Inclusion Criteria:
- Male and female patients who are at least 18 years of age;
- Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at 1
or 2 contiguous lumbar levels between L1 and L5 and are surgical candidates for interbody
lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic
claudication with or without back pain;
- Patients who have been unresponsive to at least 6 months of conservative treatments or
exhibit progressive neurological symptoms in the face of conservative treatment;
- Patients who understand the conditions of enrollment and are willing to sign an informed
consent to participate in the study.
Exclusion Criteria:
- Patients with lumbar pathologies requiring treatment at more than 2 levels;
- Patients who have had previous lumbar fusion surgery;
- Patients with lytic spondylolisthesis or a defect of the pars interarticularis;
- Patients with radiographic confirmation of Grade IV facet joint disease or degeneration;
- Patients with non-contained or extruded herniated nucleus pulposus
We found this trial at
10
sites
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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