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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200022 S003/ PAS001 |
| Date Original Protocol Accepted |
05/28/2021
|
| Date Current Protocol Accepted |
|
| Study Name |
Extended f/u of the 2-Level Simplify
|
| Device Name |
Simplify Cervical Artificial Disc
|
| Clinical Trial Number(s) |
NCT03123549
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
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| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To evaluate the 5 year long-term safety and effectiveness of the two-level Simplify Cervical Artificial Disc in subjects with cervical
radiculopathy with or without neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces
that are 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 |
170 Simplify Cervical Artificial Disc IDE subjects and 151 historical ACDF control subjects are eligible 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 levels
Neurologic evaluation
Dysphagia Handicap Index (DHI)
Effectiveness Endpoints:
Neck Disability Index (NDI) assessment
Radiographic evaluation
Pain assessments (neck and arm; neck, left arm and right arm)
Treatment satisfaction
SF-36 Health Survey
Gait Assessment
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
157 of 170 eligible investigational subjects and 134 control subjects were enrolled in the PAS.
|
| Actual Number of Sites Enrolled |
18 investigational, 31 control
|
| Patient Follow-up Rate |
At month 60, the follow-up rate is 89% for the investigational group and 79% for the control group.
|
| Final Safety Findings |
In this PAS, the overall AE and SAE rates were comparable between treatment groups. The observed AE rate for the Simplify Disc group was 75.8% (119/157) compared with 94% (126/134) in the historical ACDF control group with an SAE rate of 25.5% (40/157) in the Simplify Disc group compared with 40.3% (54/134) in the historical ACDF control group. As previously reported under the IDE study, 4 secondary surgical interventions (SSIs) occurred in the Simplify Disc group and 14 SSIs occurred in the historical ACDF control group through Day 730. Between Day 730 and Day 1825, an additional 5 SSIs occurred in the Simplify Disc group and an additional 4 SSIs occurred in the historical ACDF control group.
|
| Final Effect Findings |
The composite clinical success for the Simplify Disc group was 85.0% compared to 73.3% 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).
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