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RECRUITING
NCT04770870
NA

Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Sponsor: DT MedTech, LLC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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