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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XLIF | This group will have the XLIF procedure done. | ||
| MAS TLIF | This group will have the MAS TLIF procedure done. |
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| Measure | Description | Time Frame |
|---|---|---|
| The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. | 24 months |
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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
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Study population will consist of patients from participating site locations.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent-Jacksonville | Jacksonville | Florida | 32204 | United States | ||
| Celebration Florida Hospital |
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| Kissimmee |
| Florida |
| 34747 |
| United States |
| St. Joseph's/Candler Health System | Savannah | Georgia | 31405 | United States |
| Northwest Orthopaedic Specialists, P.S. | Paducah | Kentucky | 42003 | United States |
| Orthopaedic Clinic-Riverside Campus, University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Spine and Sports Institute | Richland | Washington | 99352 | United States |
| Northwest Orthopaedic Specialists, P.S. | Spokane | Washington | 99208 | United States |
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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