M6-C Post Approval Study (PAS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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M6-C Artificial Cervical Disc IDE Post Approval Study

Conditions
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Long Term Follow-up

Intervention / Treatment
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* Other: standard radiographic imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria Exclusion Criteria: Subjects who were withdrawn or withdrew consent to participate in the investigation Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance) Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| M6-C<br>Subjects treated with an M6-C device | Other: standard radiographic imaging<br>* standard radiographic imaging<br>|
| ACDF<br>Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF) | Other: standard radiographic imaging<br>* standard radiographic imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | annually to 10 years | 
| Patient Satisfaction | The following 5 point Likert Scale will be used to further assess subject satisfaction: How satisfied are you with the results of your surgery? Very Satisfied; Satisfied; Neutral; Unsatisfied; Very Unsatisfied All things considered, would you have the surgery again? Very likely; likely; not sure; Unlikely; Very Unlikely Would you recommend the surgery to a friend or family member? Very likely; likely; not sure; Unlikely; Very Unlikely | 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. | annually to 10 years |