Status: This trial has now been completed.
Desert Institute for Spine Care has been selected to participate in the FlexiCore™ Intervertebral Disc Study.
FlexiCore™ Intervertebral Disc Study Summary
This is a multi-center, prospective, randomized, controlled study comparing the safety and effectiveness of the FlexiCore™ Intervertebral Disc to spinal fusion surgery for the treatment of pain associated with degenerative disc disease (DDD) at a single level in the lumbo-sacral spine (L1-S1).
Approximately 25 centers will be participating in the study. The control treatment is spinal fusion. Treatment assignment is randomized using a 2 to 1 ratio. For every 2 patients who receive treatment with the FlexiCore™ Intervertebral Disc, 1 patient will receive the spinal fusion treatment.
Patients must have the following conditions and meet the following inclusion criteria in order to be considered for enrollment in the study:
Patients who have any of the following conditions or meet any of the following criteria may not participate in the study:
Visit www.spinecore.com for more information.