RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.
Degenerative Disc Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||RAMP Study: A Prospective Randomized Study Comparing Two Lumbar Fusion Procedures|
- Efficacy [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]Efficacy: Fusion of the targeted vertebral bodies (L4-L5-S1 or L5-S1) will be assessed individually at 24 months as determined by Central Radiographic Reviewer's (orthopedic surgeon) interpretation of high resolution Computed Tomography (CT) Scan.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|transacral lumbar interbody fusion procedure|
|transforaminal lumbar interbody fusion procedure (TLIF)|
Study Treatment Arms:
The transacral lumbar interbody fusion (including 1L+ and 2L+) is a minimally invasive technique that uses a transacral approach to achieve fusion at the L5-S1 or L4-L5-S1 spinal levels. The transforaminal lumbar interbody fusion (TLIF) is performed by using a posterior unilateral or bilateral incision in which the lumbar spine is accessed. Both study procedures are approved for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
Study Design, Objective:
The study objective is to demonstrate non-inferiority between the transacral lumbar interbody fusion procedure and the transforaminal lumbar interbody fusion procedure (TLIF) by meeting the primary and secondary study endpoints as listed below.
Study design, Endpoints:
Efficacy: Fusion of the targeted vertebral bodies (L4-L5 or L5-S1) by 24 months as determined by Central Radiographic Reviewer's interpretation of high resolution Computed Tomography (CT) scan.
Safety: Incidence of major device-related adverse events and/or failures by 24 months, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
Clinical Effectiveness: A 20% decrease in back pain compared to baseline by 24 months as measured by the Visual Analog Scale (VAS) score.
Clinical Effectiveness: A 20% decrease in disability compared to baseline by 24 months as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment and Analyses:
Approximately 200 subjects will be enrolled in this study and will receive one of two study treatments in the study. The enrollment period is expected to last approximately 18 months, with a 24 month follow up period. Approximately 15-20 sites will participate, and Investigators must be proficient in both of the lumbar fusion procedures.
Eight evaluations: Pre-Operative, Operative, Discharge, and at 1, 3, 6, 12, and 24 Months.
Safety and efficacy analyses will be performed at all follow-up points during the study as well as a final analysis when all subjects have completed the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716182
|United States, California|
|St. Joseph Heritage Healthcare|
|Fullerton, California, United States, 92835|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Indiana|
|Indiana Spine Group|
|Carmel, Indiana, United States, 46032|
|United States, Louisiana|
|Bone and Joint Clinic of Baton Rouge|
|Baton Rouge, Louisiana, United States, 70808|
|LSU Health Sciences Center, Department of Neurosurgery|
|New Orleans, Louisiana, United States, 70112|
|United States, Massachusetts|
|UMass Medical Center, Department of Neurosurgery|
|Worcester, Massachusetts, United States, 01655|
|United States, North Carolina|
|Cary Orthopaedic Spine Specialists|
|Cary, North Carolina, United States, 27518|
|United States, Ohio|
|Mayfield Clinic/University of Cincinnati|
|Cincinnati, Ohio, United States, 45219|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|College Station, Texas, United States, 77845|
|United States, Virginia|
|Danville Orthopedic Clinic, Inc.|
|Danville, Virginia, United States, 24541|
|Principal Investigator:||David Hart, MD||University Hospital Case Medical Center|