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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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Hinternmann Series H3 TAR Long Term Study


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General
Study Status Progress Adequate
Application Number P160036 / PAS001
Date Current Protocol Accepted  
Study Name Hinternmann Series H3 TAR Long Term Study
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 Design Description 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 Description 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.
Data Collection 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


Hinternmann Series H3 TAR Long Term 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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