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 efficacy of the M6-CTM artificial cervical disc compared with 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 you:
- Have been told you need neck surgery at two adjacent levels between C3 and 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 for at least 24 months and possibly up to 5 years
- Do not have any autoimmune disorders or cancer and are not diabetic (insulin-dependent)
- Have a BMI < 45
- Are between 18 and 75 years of age
For more information, please contact us at
telephone: 801-585-9821
email: mahanresearch@hsc.utah.edu
You may also visit Clinicaltrials.gov (study identifier NCT 104982835) or Orthofix.com to learn more.