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:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm327502.htm

The results of the trial are presented below.

Patient Satisfaction

View ChartSee what percentage of coflex® patients were satisfied with their outcome compared to fusion.

View ChartSee what percentage of coflex® patients would recommend coflex® again as a treatment option.

Outcomes

View ChartSee what percentage of coflex® patients experienced early improvement in their physical function compared to fusion patients.

View ChartSee what percentage of coflex® patients experienced lasting improvement in their physical function compared to fusion patients.

View ChartSee what percentage of coflex® patients had an early successful clinical outcome compared to fusion patients.

View ChartSee what percentage of coflex® patients had early improvement in pain and function compared to fusion patients.

View ChartSee what percentage of coflex® patients had lasting improvement in pain and function compared to fusion patients.

Pain Relief

View ChartSee what percentage of coflex® patients experienced early pain relief from their spinal stenosis symptoms compared to fusion patients.

View ChartSee what percentage of coflex® patients experienced lasting pain relief from their spinal stenosis symptoms compared to fusion patients.

View ChartSee what percentage of coflex® patients had back pain relief compared to fusion patients.

View ChartSee what percentage of coflex® patients had leg pain relief (associated with spinal stenosis) compared to fusion patients.

Other Advantages

Additional BenefitsSee additional surgical benefits of coflex® compared to fusion.

 

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.