Orthofix Medical has announced preliminary three- and four-year functional outcomes from the M6-C artificial cervical disc single-level investigational device exemption (IDE) study which has shown that the device continues to have statistically significant benefits as compared to anterior cervical discectomy and fusion (ACDF).
The findings, which were presented at the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in Miami, Florida, showed that at three years, the M6-C disc patients had a mean Neck Disability Index (NDI) score of 10.9 − significantly better than the mean of 17.2 observed in the ACDF group. A significant difference was also observed at four years, with the M6-C disc group having a mean NDI score of 10.3 compared to 19.2 for the ACDF group.
The data also indicate that at three years post-op, patients in the M6-C group had a mean neck pain Visual Analogue Scale (VAS) score of 1.1, which was significantly better than the mean of 2 observed in the ACDF control group. Similarly, a significant difference was observed at four years with an M6-C disc mean neck pain score of 1 compared to 2.3 for the ACDF group
Frank Phillips, professor of orthopaedic surgery at Rush University Medical Center and an investigator in the study, said: “Midterm study results show that patients treated with the M6-C artificial cervical disc continue to have statistically significant benefits at three and four years as measured by the NDI and neck, shoulder and arm pain as measured by the VAS scores, as compared to anterior cervical discectomy and fusion (ACDF) patients
“This is important as it demonstrates the positive results originally reported in the study have been maintained through four years.”
Kevin Kenny, president of global spine at Orthofix, added: “It is exciting to see the three- and four-year results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty
“With its unique design, the M6-C disc is one of the flagship products in our comprehensive cervical line of procedural solutions. We are proud to be able to provide this motion enabling technology to surgeons and their patients.”
A prospective, non-randomised, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 sites in the US with an average patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level symptomatic cervical radiculopathy with or without cord compression.