Clinical trials: Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle
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…
- Conditions
- Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Trial name
- NCT04770870
- Testing
- Hintermann Series H3 Total Ankle Replacement System
- Where
- 11 sites in United States
- Volunteers
- 94 people
- Sponsor
- DT MedTech, LLC
Ankle Osteoarthritis, Post-Traumatic Osteoarthritis of Ankle
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…
- Conditions
- Ankle Osteoarthritis, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Trial name
- NCT06514196
- Testing
- Hintermann Series H3 Total Ankle Replacement System
- Where
- Switzerland
- Volunteers
- 298 people
- Sponsor
- DT MedTech, LLC
Osteoarthritis
ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
- Trial name
- NCT02480868
- Testing
- ARTEBONE
- Where
- 5 sites in Finland, Poland
- Volunteers
- 34 people
- Sponsor
- BBS-Bioactive Bone Substitutes Oy