U.S. Clinical Study Results Shows Significant Improvement in Pain, Function, and Quality of Life Scores, as well as Reduction in Pain and Opioid Medications Use.
Like many new medical devices available in the U.S., the M6-C™ artificial cervical disc was evaluated through a large Investigational Device Exemption (IDE) clinical study to ensure the device was safe and effective prior to making it available to surgeons. This data was the basis for the U.S. Food and Drug Administration (FDA) approval of the M6-C artificial cervical disc for patients suffering from cervical disc degeneration. The U.S. study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression.
The overall success rate for the protocol specified primary endpoint for the M6-C disc patients was 86.8 percent at 24 months and 79.3 percent in the control group. This data statistically demonstrates that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF.
To be included in the study, participants had to be diagnosed with a damaged cervical disc or irritated nerve resulting in pain, weakness or numbness of the neck, shoulders, arms and hands requiring treatment at one cervical level from C3 to C7. This had to be demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (neck and/or arm pain, radiculopathy, etc.) and confirmed by radiographic studies (MRI, CT, X-rays, etc.). The prospective, non-randomized, concurrently controlled, multi-center clinical trial was conducted at 23 sites in the United States with an average patient age of 44 years. The results of this clinical study applies to the study participants only. Your results may vary.
The M6-C IDE Study Conclusions at 24 Months include:
Patients who received the M6-C disc demonstrated statistically significant difference 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 the 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.
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.
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