Michael Barbella, Managing Editor05.13.21
Clinical data show Orthofix Medical Inc.'s M6-C™ artificial cervical disc is beneficial three and four years after implantation compared with anterior cervical discectomy and fusion.
“Midterm study results show that patients treated with the M6-C artificial cervical disc continue to have statistically significant benefits at three and four years as measured by the Neck Disability Index (NDI) and neck, shoulder and arm pain as measured by the Visual Analog Scale (VAS) scores, as compared to anterior cervical discectomy and fusion (ACDF) patients,” said Dr. Frank Phillips, professor of Orthopedic Surgery at Rush University Medical Center and an investigator in the single-level IDE study. “This is important as it demonstrates the positive results originally reported in the study have been maintained through four years.”
NDI results at three and four years indicate:
“It is exciting to see the three- and four-year results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty,” said Orthofix President of Global Spine Kevin Kenny. “With its unique design, the M6-C disc is one of the flagship products in our comprehensive cervical line of procedural solutions. We are proud to be able to provide this motion enabling technology to surgeons and their patients.”
A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 sites in the United States with an average patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level 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 demonstrated that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF. The M6-C disc received U.S. FDA approval in February 2019 based on the results of this study.
The M6-C artificial cervical disc is a next-generation intervertebral disc designed to restore physiologic motion to the spine and is indicated as an alternative to cervical fusion. The device is comprised of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level and provides a controlled range of motion when the spine transitions in its combined complex movements. The M6-C artificial cervical disc is the only disc available in the United States with these features.
“Midterm study results show that patients treated with the M6-C artificial cervical disc continue to have statistically significant benefits at three and four years as measured by the Neck Disability Index (NDI) and neck, shoulder and arm pain as measured by the Visual Analog Scale (VAS) scores, as compared to anterior cervical discectomy and fusion (ACDF) patients,” said Dr. Frank Phillips, professor of Orthopedic Surgery at Rush University Medical Center and an investigator in the single-level IDE study. “This is important as it demonstrates the positive results originally reported in the study have been maintained through four years.”
NDI results at three and four years indicate:
- At three years, the M6-C disc patients had a mean NDI score of 10.9 − significantly better than the mean of 17.2 observed in the ACDF group.
- A significant difference was also observed at four years, with the M6-C disc group having a mean NDI score of 10.3 compared to 19.2 for the ACDF group.
- Patients receiving the M6-C disc experienced a mean improvement from the NDI baseline of 43.9 points at three years and 45.2 points at four years, compared to 35.5 and 32.8, respectively, for the ACDF cohort, with the four-year results being significantly better for the M6-C disc group.
- A greater percentage of the M6-C disc patients experienced a 15-point improvement in NDI from baseline—93.6 percent at three years and 95.7 percent at four years—compared to the ACDF cohort reporting 86.6 percent and 82.7 percent, respectively. The four-year results were significantly better for the M6-C disc group.
- One removal was reported in the M6-C group within the first four post-operative years, compared to three in the ACDF group. Five-year data are being compiled.
- At three years post-op, patients in the M6-C group had a mean neck pain VAS score of 1.1, which was significantly better than the mean of 2.0 observed in the ACDF control group.
- Similarly, a significant difference was observed at four years with an M6-C disc mean neck pain score of 1.0 compared to 2.3 for the ACDF group.
- Significant improvement results were also observed in shoulder/arm pain VAS Scores (worse side) at three years, with an average of 0.9 for the M6-C disc patients compared to 2.2 for the ACDF group, and at four years with an average of 0.6 for the M6-C disc patients compared to 2.7 for the ACDF group.
- Patients with the M6-C disc experienced a mean neck pain VAS score improvement from baseline of 6.1 points at three years and 6.2 points at four years, compared to 5.2 and 4.8, respectively, for the ACDF cohort, with the four-year scores being significantly better for the M6-C disc group.
- Patients with the M6-C disc experienced a mean improvement in shoulder/arm pain VAS scores of 6.3 at three years and 6.6 at four years. Both measures were significantly better than the improvements reported for the ACDF (5.4 at three years and 5.0 at four years post-op).
“It is exciting to see the three- and four-year results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty,” said Orthofix President of Global Spine Kevin Kenny. “With its unique design, the M6-C disc is one of the flagship products in our comprehensive cervical line of procedural solutions. We are proud to be able to provide this motion enabling technology to surgeons and their patients.”
A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 sites in the United States with an average patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level 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 demonstrated that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF. The M6-C disc received U.S. FDA approval in February 2019 based on the results of this study.
The M6-C artificial cervical disc is a next-generation intervertebral disc designed to restore physiologic motion to the spine and is indicated as an alternative to cervical fusion. The device is comprised of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level and provides a controlled range of motion when the spine transitions in its combined complex movements. The M6-C artificial cervical disc is the only disc available in the United States with these features.