Five-year data on Orthofix's M6-C artificial disc shows its effectiveness compared to anterior cervical discectomy and fusion at one level.
The data comes from an FDA investigational device exemption study, according to a May 31 news release.
Key findings include:
1. At five years, M6-C patients had a better mean neck disability index score of 47.5 points compared to 33.4 for the ACDF cohort.
2. There were statistically significant favorable results in shoulder and arm pain scores for patients in the M6-C group, and they had a mean improvement of 6.8 points.
3. At the five-year point, M6-C patients continued to have the lowest Subsequent Surgical Interventions rates at 3.1 percent compared to other FDA-approved artificial cervical discs.