M6-C Artificial Cervical Disc

Are You a Candidate for the M6-C Two-Level IDE Study?

This study is currently enrolling patients with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at 2 adjacent vertebral levels between C3 and C7.

The study’s primary objective is to evaluate the safety and effectiveness of the M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for treating two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.

• Have been told you need neck surgery at two adjacent levels between C3 to C7
• Are experiencing neck and/or arm pain after at least 6 weeks of conservative, non-surgical treatment
• Are willing and able to attend follow-up progress visits with your doctor over 24 months and possibly 5 years
• Do not have any autoimmune disorders, cancer, and not insulin-dependent diabetic
• BMI < 45
• Are between 18 years and 75 years of age

Participating DISC Doctors:

• Grant Shifflett, MD
• Ali H. Mesiwala, MD, FAANS

Study Follow-Up

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

For more information, visit M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study - Orthofix or ClincialTrials.gov (study Identifier NCT104982835) Orthofix products or services referenced herein are trademarks or registered trademarks of Orthofix Medical Inc. and its group of companies. All rights reserved.