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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P210034 / PAS001 |
| Date Original Protocol Accepted |
03/29/2022
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| Date Current Protocol Accepted |
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| Study Name |
Extended Follow-up of the Premarket Cohort
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| Device Name |
Agili-C
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| Clinical Trial Number(s) |
NCT03299959
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| 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.
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| Study Population |
Patients with joint surface lesions of the knee
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| 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.
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| 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.
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| Follow-up Visits and Length of Follow-up |
60 months (5 years) post-implant
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
251 subjects (167 investigational and 84 control)
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| Actual Number of Sites Enrolled |
26 sites (11 US and 15 OUS)
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| Patient Follow-up Rate |
At 60 months, the total follow-up rate was 83.7 %
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| Final Safety Findings |
When comparing the safety results from baseline up through the end of study at 60 months, the group differences are all reflecting a favorable safety profile for the Agili-C implant and its related procedure. Throughout the course of the study, there was no evidence of any increase in treatment-emergent events, serious events, or device-related/procedure-related events for Agili-C compared to the SSOC control and the rate of injection use, overall failure, and conversion to total knee arthroplasty were all lower for Agili-C.
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| Final Effect Findings |
Primary Endpoint: Agili-C was demonstrated to be superior over the SSOC control in change from baseline to 60 months in the average KOOS Overall Score (posterior probability of superiority = 1.000). The robustness of this outcome was confirmed through observed and change from baseline KOOS Overall Score over time. On both assessments, Agili-C outperformed the SSOC control at each timepoint, and the LB of the 95% confidence interval of between group differences at each timepoint did not contain zero, demonstrating statistical significance.
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| Study Strengths & Weaknesses |
The study described the longer-term effectiveness and safety performance of the Agili-C for the treatment of an ICRS grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3). The population consisted of continued follow-up of the original IDE study subjects. No new subjects were enrolled. Subjects and evaluators remained blinded. Subjects were informed of their treatment after the last evaluation. The follow-up rates at the longer timepoints were slightly lower than those that would be excepted for ongoing follow-up during the course of an IDE and for filing a PMA (83.7% compared to 85%), they are reasonable rates for a post-approval study collecting data out to 6 years post-op.
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| Recommendations for Labeling Changes |
There are no new safety or efficacy findings that alter the conclusions that led to PMA approval, or would require addition to labeling. The sponsor has been instructed to submit a modified package insert containing the updated timecourse distributions of AEs and clinical and radiographic outcome out to 60 months post-op.
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