M6-C disc is indicated as an alternative to cervical fusion to restore physiologic motion to the spine
Orthofix Medical has announced the first patient implant in a US Food and Drug Administration (FDA) clinical study of the M6-C artificial cervical disc.
The study is being conducted under a US Investigational Device Exemption (IDE).
It will evaluate the safety and effectiveness of the M6-C compared to anterior cervical discectomy and fusion (ACDF) to treat contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.
In 2019, FDA approved the M6-C artificial cervical disc for single-level implantation from C3 to C7.
The global medical device company will carry out a concurrent enrollment of patients in the M6-C treatment group and the ACDF control group for the study.
In the study, 263 patients are expected to undergo either a two-level cervical artificial disc procedure or an instrumented ACDF procedure.
The study evaluation will be done through patient-reported outcomes at six weeks, three months, six months, 12 months and 24 months.
Orthofix global spine president Kevin Kenny said: “To date there have been more than 55,000 implantations worldwide of the M6-C artificial cervical disc.
“We are excited to begin this study as it supports our commitment to continue to build upon the global body of evidence supporting the use of the M6-C artificial cervical disc as a safe and effective treatment for patients suffering from the debilitating pain of degenerative disc disease.”
According to Orthofix, the M6-C disc is indicated as an alternative to cervical fusion to restore physiologic motion to the spine.
Following native disc removal, M6-C restores biomechanical function at the treated level to preserve motion.
Recently, Orthofix announced the the launch and first patient implants with the fiberFUSE Strip, which is an advanced demineralised fiber bone-graft solution containing cancellous bone.
The fiberFUSE Strip contains a mixture of mineralised cancellous and demineralized cortical bone.