M6-C Artificial Cervical Disc
Two-Level IDE Pivotal Study
The Orthofix M6-C™ artificial cervical disc is currently approved by the FDA for use in single level surgical procedures. The primary objective of the study is to evaluate the safety and effectiveness of the Orthofix M6-C™ artificial cervical disc in patients with contiguous two level symptomatic cervical radiculopathy with or without cord compression.
Artificial disc replacement surgery is very similar to anterior cervical discectomy and fusion (ACDF) surgery. Both procedures remove the flattened disc. However, when the flattened disc is removed for disc replacement, the space in between the vertebrae is filled with a specialized implant called an artificial disc, instead of a bone graft. The artificial disc is designed to restore the spacing between the vertebrae while allowing some motion.
Are You a Candidate for the M6-C Two-Level IDE Study?
Please answer the following questions to help determine if you may be a candidate for either artificial cervical disc replacement or anterior cervical fusion (ACDF)
- Are you 18 to 75 years of age?
- Have been told that you need cervical spine (neck) surgery at two consecutive levels?
- Are you experiencing continued neck and/or arm pain after six or more weeks of conservative, nonsurgical treatment?
- Have no autoimmune disorders, not insulin dependent diabetes, or cancer?
- Are you able and willing to attend follow-up progress visits with your doctor over 24 months and possibly longer?
If you answer “yes” to all five questions, you may be a candidate for either study treatment option, cervical disc replacement, or anterior cervical discectomy and fusion. Please consult your doctor to learn more.
Clinical study follow-up will ask you to return to see your doctor to evaluate your progress at the following times after surgery: six weeks, three months, six months, one year and two years. Then you may be asked to return yearly (possibly up to five years) after surgery.
During these return follow up visits, your doctor will do the following:
- Conduct physical exam
- Test your reflexes
- Test the muscle strength of your arm muscles
- Test your ability to feel touch on different areas of your neck & arms
- Take X-rays of neck
- Answer questions about your pain, your ability to do daily activities, how you feel, and how well you think you are recovering.
Each visit should typically last 1-2 hours, completing the questionnaires should take you about 10-20 minutes