Clinical Research Directory
Browse clinical research sites, groups, and studies.
2 clinical studies listed.
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Tundra lists 2 Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT06514196
Post- Approval Hintermann Series H® Study 1
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.
Gender: All
Ages: 21 Years - Any
Updated: 2024-07-23
NCT04770870
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
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.
Gender: All
Ages: 21 Years - Any
Updated: 2024-06-25
9 states