Status:
ACTIVE_NOT_RECRUITING
Post- Approval Hintermann Series H® Study 1
Lead Sponsor:
DT MedTech, LLC
Conditions:
Ankle Osteoarthritis
Post-Traumatic Osteoarthritis of Ankle
Eligibility:
All Genders
21+ years
Brief 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 saf...
Detailed Description
The Hintermann Series H3® (H3) prosthesis is a mobile bearing total ankle replacement (TAR) indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoa...
Eligibility Criteria
Inclusion
- Skeletally mature
- Primary diagnosis of osteoarthritis, post-traumatic arthritis or rheumatoid arthritis
- Primary total ankle replacement
- Unilateral or the first ankle implanted if bilateral and the surgery dates for both sides are at least 6 months apart
- Implanted with the correct device without screws (for investigational arm),
- 3rd generation Hintermann Series H3 Total Ankle Replacement;
- Poor pre-operative American Orthopaedic Foot and Ankle Society Hindfoot Score (\< 60 points)
- Implanted in 2013 or earlier). Note that all subjects implanted in 2013 or earlier were included regardless of whether they were revised prior to the 2 year endpoint.
- Gave informed consent (unless IRB/Ethics Committee waived this requirement)
Exclusion
- Prior TAR or arthrodesis at the involved ankle joint
Key Trial Info
Start Date :
June 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 20 2025
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT06514196
Start Date
June 18 2020
End Date
January 20 2025
Last Update
July 23 2024
Active Locations (1)
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1
Kantonsspital Baselland
Bruderholz, Switzerland, CH-4101