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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Hintermann Series H3 TAR Performance Study


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General
Study Status Progress Adequate
Application Number P160036 / PAS002
Date Current Protocol Accepted 10/15/2021
Study Name Hintermann Series H3 TAR Performance Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this multi-center post-approval study is to meet the conditions of the PMA approval for the H3 TAR, to evaluate the trends in performance among implant sizes, and to assess the outcomes of the primary surgeon of the premarket study that supported PMA approval, compared to other surgeons that are less familiar with the device.
Design: Prospective, multicenter, single arm post approval study
Study Population Description Patients who have discussed options for management of a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.), and who have decided to undergo total ankle replacement, are candidates for this study.
Sample Size 232 Subjects/13 US clinical sites
Data Collection Safety:
Reoperation, revisions or removals of the H3 TAR device Incidence, occurrence, and types of serious device-related adverse events
Nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome of any adverse event
Effectiveness:
Survivorship (absence of removal/revisions to include polyethylene revision)
AOFAS Scores
VAS Scores
Subject Satisfaction Surveys
SF-36
PROMIS - Global Health
PROMIS – Emotional Distress-Anxiety
PROMIS – Emotional Distress-Depression
PROMIS – Pain Intensity
Radiographs:
Loosening
Osteolysis
Implant migration
Any other findings
Explant analysis:
Any explanted devices / device components will be returned and handled for analysis as described in Attachment G: Explant and Revision Protocol
Follow-up Visits and Length of Follow-up 5 years post procedure


Hintermann Series H3 TAR Performance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 06/03/2020 06/03/2020 On Time
2 year report 06/03/2021 06/04/2021 Overdue/Received
3 year report 06/03/2022 06/06/2022 Overdue/Received
4 year report 06/03/2023    
5 year report 06/02/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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