Orthofix Medical announced full 2-year outcomes from its U.S. Investigational Device Exemption study of the M6-C™ artificial cervical disc vs. anterior cervical discectomy and fusion (ACDF).
Results from the prospective, non-randomized, concurrently controlled clinical trial indicate that patients treated with M6-C had significant improvements in pain, function and quality of life. Further, at 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those who received M6-C.
Other study findings included:
- A statistically significant difference in the average mean surgery time – 74.5 minutes for M6-C procedures vs. 120.2 for ACDF
- A statistically significant difference in the mean length of hospital stay – 0.61 days for M6-C patients vs. 1.10 days for ACDF patients
- Lower subsequent surgery rates at the treated level – 4.8% of ACDF patients compared to 1.9% of M6-C disc patients
- No device migrations reported
- A 92% patient satisfaction rate with M6C
The M6-C disc received FDA Premarket Approval in 1Q19 based on the results of this study.