What is cervical disc degeneration?
Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury. For many patients with cervical disc degeneration, spine surgeons have used the M6-C disc to replace the patient’s damaged disc with one that closely mimics their natural disc, enabling the patient to regain motion and return to their normal activities.
What is the M6-C™ artificial cervical disc?
The M6-C artificial cervical disc is a next-generation artificial disc developed to replace a vertebral disc damaged by cervical disc degeneration. The M6-C disc is designed to help restore motion to the spine and is an option for patients needing artificial disc replacement as an alternative to cervical fusion. By allowing your spine to move naturally, the M6-C artificial disc is designed to potentially minimize the stress to adjacent discs and other vertebral structures.
What else is unique about the M6-C artificial cervical disc?
The M6-C disc is the only disc designed with a shock-absorbing nucleus and fiber annulus that work together to replicate the controlled range of movement and cushioning effect of the natural disc. This unique product is designed to mimic your spine’s natural structure and movement, including backward and forward, side to side, up and down, and rotate left and right.
Secondary outcomes at 24 months include:
Patients who received the M6-C disc demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24.
Meaningful clinical improvement was seen in the following pain scores:
– 91.2 percent of patients who received the M6-C disc reported an improvement in neck pain compared to 77.9 percent in patients who underwent the ACDF procedure.
– 90.5 percent of the M6-C patients reported improvement in arm pain scores compared to 79.9 percent in ACDF patients.
Prior to surgery, 80.6 percent of the M6-C disc patients and 85.7 percent of the ACDF patients were taking some type of pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C patients who were still taking some type of pain medication dropped to 14.0 percent compared to 38.2 percent of the ACDF patients.
Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.
– There was a statistically significant difference in the average mean surgery time – 74.5 minutes for patients receiving the M6-C disc versus 120.2 minutes for those patients having the ACDF procedure.
– In addition, there was a statistically significant difference in the mean length of hospital stay – 0.61 days for the M6-C patients versus 1.10 days for ACDF patients.
– Subsequent surgery at the treated level was needed in 4.8 percent of the ACDF patients compared to 1.9 percent of the M6-C disc patients.
– There were no device migrations reported in the study.
– Overall patients receiving the M6-C disc reported a 92-percent satisfaction rate with the surgery,
and 93 percent said they would have the surgery again.
– There were 3.8 percent serious adverse events related to the device or procedure in the M6-C
disc group versus 6.1 percent in the ACDF group.
The M6-C disc received U.S. Food and Drug Administration (FDA) approval in February 2019 based on the results of this study.
What is cervical disc degeneration?