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Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Sponsor: DT MedTech, LLC
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.
Official title: Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
232
Start Date
2022-02-01
Completion Date
2029-04
Last Updated
2024-06-25
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (10)
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, United States
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States
Paley Orthopedic & Spine Institute
West Palm Beach, Florida, United States
Orthopaedic Associates
Evansville, Indiana, United States
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
New Mexico Bone and Joint Institute
Alamogordo, New Mexico, United States
Duke Orhtopaedics Arringdon
Morrisville, North Carolina, United States
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma, United States
MUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina, United States
Spring Branch Podiatry, PLLC
Houston, Texas, United States