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 Long Term Study

General
Study Status	Ongoing
Application Number / Requirement Number	P160036 / PAS001
Date Original Protocol Accepted	11/29/2019
Date Current Protocol Accepted
Study Name	Hintermann Series H3 TAR Long Term Study
Device Name	Hintermann Series H3 Total Ankle Replacement System
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	Other Data Source
Comparison Group	Historical Control
Analysis Type	Analytical
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The objective of this single-center, single arm study is to determine the 10-year survivorship and effectiveness of total ankle arthroplasty using the H3 TAR System in comparison to historical literature controls for a legally marketed mobile bearing ankle.
Study Population	Primary Safety and Effectiveness Cohort from the PMA
Sample Size	All living subjects (n=298) from the Updated PSE cohort that were included in the PMA will continue to be followed until they reach the 10-year postoperative interval.
Key Study Endpoints	The primary effectiveness measurement for this study is a composite of the following parameters: AOFAS Score Survivorship (absence of removal/revisions to include polyethylene revision), Percentage of subjects with a serious device-related adverse event other than a revision or removal. The primary safety endpoint for this study is the evaluation of reoperations, revisions, or removals of the H3 device occurring within 10 years of surgery. Additional study endpoints are: 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.
Follow-up Visits and Length of Follow-up	10 years
Interim or Final Data Summary
Interim Results	All patients were enrolled at a single center outside of the United States with approximately 80% of surgeries performed by the same surgeon, which limits generalizeability of the study results to US patients and US clinical practice. Additional analyses are planned in the final report to assess the risk of revision.
Actual Number of Patients Enrolled	280 patients enrolled from the Primary Safety & Effectiveness cohort
Actual Number of Sites Enrolled	One (1) site
Patient Follow-up Rate	Not provided

Hintermann Series H3 TAR Long Term 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
5 year report	06/02/2024	06/03/2024	Overdue/Received
final report	03/03/2025

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