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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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  
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.
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
Data Collection American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score at 2 years or later, Survivorship (absence of revision/removal of any metal component) at 5 years or later, Occurrence of an SADE other than a removal/revision within 2 years, . AOFAS Scores at time points other than 2 years, VAS Scores, Subject Satisfaction Surveys, SF-36
Follow-up Visits and Length of Follow-up Study participation will be 5 years


Hintermann Series H3 TAR Performance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 06/03/2020 06/03/2020 On Time
two year report 06/03/2021    
three year report 06/03/2022    
four year report 06/03/2023    
five 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

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