|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200022 / PAS001 |
| Date Original Protocol Accepted |
11/05/2020
|
| Date Current Protocol Accepted |
05/26/2021
|
| Study Name |
Extended Follow-up of IDE Subjects
|
| Device Name |
Simplify® Cervical Artificial Disc
|
| Clinical Trial Number(s) |
NCT02667067
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To evaluate the 5-year long-term safety and effectiveness of the Simplify Cervical Artificial Disc in subjects with symptomatic cervical
radiculopathy with or without neck pain or myelopathy due to a single level abnormality localized to the level of the disc space that is
unresponsive to conservative management.
Design: A continuation of the prospective, multi-center, historically controlled IDE study population to evaluate the long-term safety and
effectiveness of the Simplify Cervical Artificial Disc.
|
| Study Population |
Investigational Device: Simplify Cervical Artificial Disc
Historical Control: Anterior Cervical Discectomy and Fusion (ACDF)
|
| Sample Size |
142 Simplify Cervical Artificial Disc IDE subjects and 106 historical ACDF control subjects are elgible for for the PAS study
|
| Key Study Endpoints |
Safety Endpoints:
• Collection and evaluation of all adverse events for severity and device and/or procedure-relatedness
• Evaluation of device failure (device breakage, migration, or mechanical failure) as defined in Radiographic Evaluation Protocol
• Subsequent surgical procedures (revision, removal, reoperation, or supplemental fixation) at the index level
• Neurologic evaluation – investigational device only
• Dysphagia Handicap Index (DHI) – investigational device only
Effectiveness Endpoints:
• Neck Disability Index (NDI) assessment
• Radiographic evaluation
• VAS pain assessments (neck and arm; neck, left arm and right arm (investigational device only))
• Treatment satisfaction
• SF-12 Health Survey
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
132 investigational device subjects, 106 historical ACDF control subjects enrolled in PAS.
|
| Actual Number of Sites Enrolled |
15 of 17 investigational device sites, 21 of 24 historical control sites
|
| Patient Follow-up Rate |
At month 60, the follow-up rate is 89% for the investigational device and 61% for the PS selected ACDF control subjects.
|
| Final Safety Findings |
In this PAS, the overall AE and SAE rates were comparable between treatment groups. There was no difference between groups with regard to AEs categorized as definitely device- or procedure-related; however, there was a slightly higher rate of device-related spasm AEs in the Simplify group and a slightly higher rate of device-realted pain (narcotic given) in the ACDF control group. There were two instances of secondary surgical interventions (SSIs) in the Simplify group and five SSIs in the ACDF control group after the 24-month timepoint. See tables below.
|
| Final Effect Findings |
The composite clinical success for the Simplify Disc group was 91.1% compared to 74.6% for the historical ACDF control group. The study success criteria for non-inferiority as well as for superiority have been met.
|
| Study Strengths & Weaknesses |
This 5-year follow-up study had high follow-up rates for the investigational group but lower than the recommended 85% follow-up rate for the historical control group.
|
| Recommendations for Labeling Changes |
It is recommended that the labeling be updated with the results of the PAS study (i.e., data at 60-months).
|
