M6-C™ Artificial Cervical Disc 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-CTM 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.
You may be eligible if you:
• 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
Please contact research@inifoundation.org for more information.
You may also visit M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study - Orthofix
You may also visit ClincialTrials.gov (study Identifier NCT104982835) at https://clinicaltrials.gov/ct2/show/NCT04982835
