Orthofix has announced the first patient implant in a US Food and Drug Administration (FDA) investigational device exemption (IDE) study that will evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.
Todd Lanman, a spinal neurosurgeon from Beverley Hills, USA, who performed the first patient implant in the study, said: “Artificial cervical disc replacement is rapidly becoming the standard of care for patients suffering from degenerative cervical disc disease because it preserves motion, unlike ACDF procedures.
“The M6-C artificial cervical disc two-level study will provide additional data to validate the effectiveness of disc replacement over fusion in patients suffering from degeneration in two contiguous levels.”
In the investigational device exemption (IDE) study, patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group. A total of 263 patients will undergo either a two-level cervical artificial disc procedure or an instrumented ACDF procedure as per site group assignment. Patients will be evaluated clinically, radiographically, and via the collection of patient-reported outcomes at six weeks, three months, six months, 12 months and 24 months. The primary endpoint is overall success at 24 months.
“To date there have been more than 55,000 implantations worldwide of the M6-C artificial cervical disc,” said Orthofix president of global spine, Kevin Kenny. “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.”
The M6-C artificial cervical disc was FDA-approved for single-level implantation from C3 to C7 in 2019.