Patients treated with Orthofix's M6-C artificial cervical disc reported higher pain, function and quality of life scores than patients who underwent anterior cervical discectomy and fusion, according to results of a U.S. Investigational Device Exemption study.
Researchers conducted a clinical trial across 23 U.S. sites.
Six findings:
1. The M6-C artificial cervical disc was linked to reduced pain and opioid use compared to ACDF patients. The control group continued using opioids at seven times the rate of M6-C patients at 24 months.
2. The M6-C disc patients had an 86.8 percent overall success rate at 24 months, compared to 79.3 percent in the control group.
3. The average surgery time was 74.5 minutes for M6-C patients and 120.2 minutes for ACDF patients.
4. Subsequent surgery was necessary in 4.8 percent of ACDF patients and 1.9 percent of M6-C disc patients.
5. About 4 percent of patients in the M6-C group experienced serious adverse events related to the device or procedure, compared to about 6 percent in the ACDF group.
6. Cervical disc replacement with the M6-C disc is on-par with ACDF treatment, researchers concluded.