XLIF® vs. 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.
|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 ]
|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)|
This group will have the XLIF procedure done.
This group will have the MAS TLIF procedure done.
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.
|United States, Florida|
|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|