XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
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Purpose
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.
| Condition |
|---|
|
Spondylolisthesis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
XLIF
This group will have the XLIF procedure done.
|
|
MAS TLIF
This group will have the MAS TLIF procedure done.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study population will consist of patients from participating site locations.
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
Contacts and Locations| United States, Florida | |
| St. Vincent-Jacksonville | |
| Jacksonville, Florida, United States, 32204 | |
| Celebration Florida Hospital | |
| Kissimmee, Florida, United States, 34747 | |
| United States, Georgia | |
| St. Joseph's/Candler Health System | |
| Savannah, Georgia, United States | |
| United States, Kentucky | |
| Western Baptist Hospital | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Minnesota | |
| Orthopaedic Clinic-Riverside Campus, University of Minnesota | |
| Minneapolis, Minnesota, United States, 55454 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Kadlec Neuroscience Center, Kadlec Regional Medical Center | |
| Richland, Washington, United States, 99352 | |
More Information
No publications provided
| Responsible Party: | NuVasive |
| ClinicalTrials.gov Identifier: | NCT01024699 History of Changes |
| Other Study ID Numbers: | NUVA.X0901 |
| Study First Received: | December 1, 2009 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Spondylolisthesis Spondylolysis Spondylosis |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013