|
|
| 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
|
| 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.
|
