|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210034 / PAS001 |
| Date Original Protocol Accepted |
03/29/2022
|
| Date Current Protocol Accepted |
|
| Study Name |
Extended Follow-up of the Premarket Cohort
|
| Device Name |
Agili-C
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, multicenter, open-label, randomized 2:1, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.
|
| Study Population |
Patients with joint surface lesions of the knee
|
| Sample Size |
Up to 251 subjects (167 Agili-C™ subjects and 84 SSOC subjects) who were enrolled into the Pivotal study and are continuing follow up.
|
| Key Study Endpoints |
Primary Endpoint:
Change from baseline to 60 months in the average overall KOOS score (Pain, Symptoms, QOL, ADL & Sports)
Safety Endpoint:
Adverse events, including serious adverse events, reoperations and revisions, up to 60 months
Confirmatory Secondary endpoints:
This trial will have one primary endpoint and 6 confirmatory secondary endpoints for labeling purposes. These will be tested sequentially, and Type I Error controlled hierarchically. Trial success will be declared if the primary endpoint has been met. Additional labeling claims will be made for confirmatory secondary endpoints met in sequence following success on the primary endpoint:
Change from baseline to 60 months in the average overall KOOS score (Pain, Symptoms, QOL, ADL & Sports)
Additional Secondary endpoints:
KOOS subscores, MRI defect fill %, IKDC, SF-12, Tegner, Lysolm, subgroup analyses.
|
| Follow-up Visits and Length of Follow-up |
60 months (5 years) post-implant
|
| Interim or Final Data Summary |
| Interim Results |
The overall adverse event rate was less for the Agili-C Group (68.3%) compared to the SSOC group (79.8%). The most common serious AEs in the Agili-C group were “increased transient or chronic pain in the operated joint, compared to baseline” (n=6, 3.6%), COVID-19 (n=5, 3.0%), contusion (n=4, 2.4%), and arthralgia and meniscus injury (n=3, 1.8%). One case of death, due to COVID-19 related respiratory insufficiency, was reported in the 2022 36-month PAS report (R001). No additional deaths have occurred since the previous report.
Agili-C continues to demonstrate superiority over SSOC in KOOS Overall Score at 48 months relative to SSOC, and also continues to demonstrate superiority over the SSOC control on all other efficacy endpoints.
|
| Actual Number of Patients Enrolled |
251
|
| Actual Number of Sites Enrolled |
22
|
| Patient Follow-up Rate |
83% at 36-month
79% at 48-month
76% at 60-month
|
