Clinical Studies

M6-C™ Artificial Cervical Disc Two-Level IDE Clinical 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.

M6-C-artifiicial-disc-orthofix

Clinical Studies

M6-C-artifiicial-disc-orthofix

M6-C™ Artificial Cervical Disc Two-Level IDE Clinical 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.

You may be eligible for the study if:

  • 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

 

For more information and resources, please visit:

ClincialTrials.gov (study Identifier NCT104982835).

Skip to content