An observational study in Cervical Degenerative Disc Disease, Cervical Radiculopathy and Cervical Spinal Cord Compression, sponsored by Spinal Kinetics. Active, not recruiting at 21 sites in United States. Open to participants aged 21 Years to 68 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Spinal Kinetics · Observational
The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.
A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.
488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.
This study's enrollment of 152 is above the median of 93 across 98 observational studies indexed under Radiculopathy.
Browse Radiculopathy studies →Spinal Kinetics is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects eligible for study enrollment will include subjects implanted in the M6-C™ IDE pivotal study
Exclusion Criteria:
Subjects treated with an M6-C device
Other: standard radiographic imaging · Device: cervical total disc replacement
Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF)
Other: standard radiographic imaging
standard radiographic imaging
Artificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients.
Also known as: cervical disc arthroplasty, cervical artificial disc replacement
Overall subject success
A study subject will be considered an overall success if he/she meets the following criteria: * No serious adverse event(s) classified as device or device procedure related (as determined by the CEC), and * No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation), and * Maintenance or improvement in neurological function, and * Improvement on the NDI of at least 15 points.
Time frame: 10 year follow-up
Neck Disability Index (NDI)
The NDI is a patient reported outcome questionnaire for the measurement of pain and function related to cervical spine problems. A total NDI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the NDI score ranges from 0% to 100%. A lower score represents less pain and dysfunction.
Time frame: annually to 10 years
Neck and arm pain
A visual analogue scale is a patient reported outcome measure utilized to determine neck and arm pain on a zero to ten scale with zero being the least amount of pain and 10 the most possible pain.
Time frame: annually to 10 years
SF-36 Health Survey
The SF-36 is a patient reported outcome questionnaire to measure health-related Quality of Life. An increase in score from baseline represents an improvement in health.
Time frame: annually to 10 years
Patient Satisfaction
The following 5 point Likert Scale will be used to further assess subject satisfaction: 1. How satisfied are you with the results of your surgery? Very Satisfied; Satisfied; Neutral; Unsatisfied; Very Unsatisfied 2. All things considered, would you have the surgery again? Very likely; likely; not sure; Unlikely; Very Unlikely 3. Would you recommend the surgery to a friend or family member? Very likely; likely; not sure; Unlikely; Very Unlikely
Time frame: annually to 10 years
Odom's Criteria
At the 5, 7 and 10 year follow-up visits, the Investigator will rate the clinical disposition of each study subject according to Odom's Criteria\[18\] as follows: Excellent: No symptoms related to cervical disease. Able to perform daily activities without limitations. Good: Moderate symptoms related to cervical disease. Able to perform daily activities without significant limitations. Satisfactory: Slight improvement is symptoms related to cervical disease. Significant limitations in daily activities. Poor: No improvement in, or aggravation of, symptoms related to cervical disease. Not able to perform daily activities.
Time frame: annually to 10 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Spinal Kinetics