coflex® Study Results
The coflex® implant was compared to pedicle screw spinal fusion surgery in a randomized FDA clinical trial. A brief overview of information related to FDA’s approval to market coflex®, as well as links to the Summary of Safety and Effectiveness Data (SSED) and product labeling can be accessed by visiting the following link:
The results of the trial are presented below.
A patient was deemed a clinical success if they had clinically significant improvement in pain and function (Oswestry Low Back Pain Disability Index (ODI)); no revisions, reoperations, removals, or major device related complications; and no epidural injections. Successful pain relief was measured by a 15-point improvement in ODI. In the clinical study, patients who received coflex® demonstrated favorable results compared to those patients who had pedicle screw spinal fusion surgery.
Although the coflex® device provides tremendous benefits to many patients, it is not for everyone. If you are a patient, please contact your spine specialist to discuss whether or not you are a candidate for this procedure.
Disclaimer: This content is for educational purposes only and does not replace having a conversation with a doctor.