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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TAR Performance Descriptive Study

General
Study Status	Delayed
Application Number / Requirement Number	P160036 / PAS003
Date Original Protocol Accepted	09/20/2024
Date Current Protocol Accepted
Study Name	TAR Performance Descriptive Study
Device Name	Hintermann Series H3 Total Ankle Replacement System
General Study Protocol Parameters
Study Design	Prospective & Retrospective Study
Data Source	External Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	Objective: 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 with data supplementation from the UK National Joint Registry (UK NJR)
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	US Population: 94 subjects/ 10 Clinical Sites UK Population: 407 subjects / 45 Clinical Sites
Key Study Endpoints	Primary Endpoints for US population: • Survivorship (absence of revision to metal components only) • Survivorship (absence of revision to metal and polyethylene components) Additional Endpoints for US population: • American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more • Percentage of subjects with a serious device related adverse event, other than a revision or removal within 2 years • Incidence, occurrence, and types of serious device related adverse events • Nature, onset, duration, severity, relationship to the device, relationship to the operative procedure, and outcome of any adverse event • Visual Analog Scale (VAS) score • Subjects Satisfaction Surverys • SF-36 • Radiographs (loosening, osteolysis, implant migration, other findings) • Explant analysis UK population: • Survivorship (absence of revision to metal components only) • Survivorship (absence of revision to metal and polyethylene components)
Follow-up Visits and Length of Follow-up	5 years

TAR Performance Descriptive Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
66 month report	12/02/2024	12/03/2024	Overdue/Received
data analysis report	12/20/2024	12/20/2024	On Time
6 year report	06/02/2025	06/03/2025	Overdue/Received
78 month report	12/02/2025
7 year report	06/02/2026

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