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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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M6-C Artificial Cervical Disc-Extended Follow-up


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General
Study Status Ongoing
Application Number /
Requirement Number
P170036 / PAS001
Date Original Protocol Accepted 08/02/2019
Date Current Protocol Accepted 10/08/2020
Study Name M6-C Artificial Cervical Disc-Extended Follow-up
Device Name M6-C Artificial Cervical Disc
Clinical Trial Number(s) NCT01609374 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Objective: To evaluate the 10-year long-term safety and effectiveness of the M6-C™ Artificial Cervical Disc in subjects with symptomatic cervical radiculopathy with or without cord compression.

Design: A continuation of the Prospective, multi-center, concurrently controlled IDE Study population to evaluate the long-term safety and effectiveness of the M6-C™ Artificial Cervical Disc.
Study Population Treatment group: M6-C™ Artificial Cervical Disc
Control group: Anterior Cervical Discectomy and Fusion (ACDF)
Sample Size Expected 122 M6-C™ IDE subjects and 53 ACDF control subjects
Key Study Endpoints Safety Endpoints:
The evaluation of all adverse events including device related, device procedure related, and additional serious adverse events
Explant and histological analysis
Subsequent surgical interventions
Neurological function

Effectiveness Endpoints:
Neck Disability Index (NDI)
Neck and arm pain - Visual Analog Scale (VAS)
Patient Satisfaction
Quantitative and qualitative radiographic assessments. In addition to endpoints studied for the PMA, these assessments will be used to evaluate range of motion and adjacent segment degeneration.

Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results Safety results:
As of the time of this report, no statistically significant differences are observed between M6-C and the concurrently-enrolled ACDF groups in the rates of any adverse event, any serious adverse event, and device- or procedure- related adverse events. The most commonly reported adverse events in the study to date are Dysphasia/Dysphonia, Neck and/or Arm Pain, Neurologic complications. The rates of device-related AE between the cohorts were not significantly different.

Effectiveness results:
Significantly lower mean NDI (Neck Disability Index) scores are observed for the M6-C group at most post-operative time points, and a greater mean improvement in NDI is observed for M6-C subjects, compared to ACDF, at most post-operative assessment intervals. Similar benefits are observed for Neck and Shoulder/Arm Pain, as measured by the Visual Analogue Scale. Health and quality of life, as measured by the SF-12, reveals a greater benefit associated with M6-C as compared to ACDF in both Physical and Mental Health components.
Actual Number of Patients Enrolled 151
Actual Number of Sites Enrolled 20
Patient Follow-up Rate 70.3% for the investigational group (M6-C) and 61.1% for the control group (ACDF) at 72 months
Study Strengths & Weaknesses Strengths: Collection of long-term outcome data of desired patient population, collection of explants for any device failures.
Weaknesses: Potential for loss at follow up.


M6-C Artificial Cervical Disc-Extended Follow-up Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/07/2019 07/30/2019  
1 year report 02/06/2020 01/31/2020 On Time
18 month report 08/06/2020 07/07/2020 On Time
2 year report 02/05/2021 02/09/2021 Overdue/Received
3 year report 02/05/2022 02/09/2022 Overdue/Received
4 year report 02/05/2023 02/10/2023 Overdue/Received
5 year report 02/05/2024 02/05/2024 On Time
6 year report 02/05/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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