Post-Approval Studies (PAS) Database

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

General
Study Status	Delayed
Application Number / Requirement Number	P160036 / PAS002
Date Original Protocol Accepted	11/29/2019
Date Current Protocol Accepted	10/15/2021
Study Name	Hintermann Series H3 TAR Performance Study
Device Name	Hintermann Series H3 Total Ankle Replacement System
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 Objectives	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	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
Key Study Endpoints	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
Interim or Final Data Summary
Actual Number of Patients Enrolled	101 subjects enrolled (signed informed consent and began screening)
Actual Number of Sites Enrolled	11

Hintermann Series H3 TAR Performance Study Reporting Schedule

Reporting 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	06/02/2023	On Time
amended report	05/23/2024	05/23/2024	On Time
5 year report	06/02/2024	06/03/2024	Overdue/Received
66 month report	12/02/2024
6 year report	06/02/2025

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background