Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Condition(s) studied
Investigational drug(s) / intervention(s)
Hintermann Series H3 Total Ankle Replacement System: Intervention will include receiving the FDA approved Hintermann Series H3 Total Ankle Replacement System, to include a tibial component, a polyethylene inlay, and a talar component.
Study summary
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.
Eligibility
Primary outcome measure(s)
- Primary Safety Measurement — 5-years
The Primary Safety Measurement for this study is the percentage of patient subjects with a serious device-related adverse event, other than a revision or removal within 2 years. - Primary Effectiveness Measurement — 5-years
The co-primary effectiveness measurements for this study are the American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more, the survivorship (absence of removal/revisions of metal components) within 5 years post-surgery, and the percentage of subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Ortho Arkansas | Little Rock | Arkansas | |
| Los Angeles Institute of Foot and Ankle Surgery | Mission Hills | California | |
| Florida Orthopedic Foot & Ankle Center | Sarasota | Florida | |
| Paley Orthopedic & Spine Institute | West Palm Beach | Florida | |
| Orthopaedic Associates | Evansville | Indiana | |
| Department of Orthopedic Surgery, Johns Hopkins Outpatient Center | Baltimore | Maryland | |
| Christus St Vincent | Alamogordo | New Mexico | |
| Duke Orhtopaedics Arringdon | Morrisville | North Carolina | |
| Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma | Oklahoma City | Oklahoma | |
| MUSC Department of Orthopaedics/Foot and Anke Services | Charleston | South Carolina | |
| Spring Branch Podiatry, PLLC | Houston | Texas |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04770870 on ClinicalTrials.gov ↗ ← All trials in the USA