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Post- Approval Hintermann Series H® Study 1
Sponsor: DT MedTech, LLC
Summary
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361). This will be a Prospective, single-center, single arm study.
Official title: Post- Approval Study 1: Long Term Follow Up of the Hintermann Series H® Total Ankle Replacement System
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
298
Start Date
2020-06-18
Completion Date
2025-01-20
Last Updated
2024-07-23
Healthy Volunteers
No
Conditions
Interventions
Hintermann Series H3 Total Ankle Replacement System
The H3 includes a metal tibial component, a polyethylene sliding insert (PE inlay), and a metal talar component.
Locations (1)
Kantonsspital Baselland
Bruderholz, Switzerland