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.
Inclusion criteria
Patients must have the following conditions and meet the following inclusion criteria in order to be considered for enrollment in the study:
Exclusion criteria
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.
LEADERS IN MINIMALLY INVASIVE SPINE CARE
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