Status:
RECRUITING
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Lead Sponsor:
DT MedTech, LLC
Conditions:
Osteoarthritis Ankle
Post-Traumatic Osteoarthritis of Ankle
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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...
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
- Each potential subject must be an appropriate candidate for mobile bearing TAR by having: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease, as determined by the Principle Investigator.
- Willingness to participate in the study and follow-up visits
- Written informed consent, including authorization to release collected health data
Exclusion
- Skeletal immaturity
- Bone stock inadequate to support the device including:
- Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
- Avascular necrosis of the talus
- Active or prior deep infection in the ankle joint or adjacent bones
- Malalignment or severe deformity of involved or adjacent anatomic structures including:
- Hindfoot or forefoot malalignment precluding plantigrade foot
- Significant malalignment of the knee joint
- Insufficient ligament support that cannot be repaired with soft tissue stabilization (syndesmosis disruption)
- Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
- Neuromuscular disease resulting in lack of normal muscle function about the affected ankle
- Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
- Poor skin and soft tissue quality about the surgical site
- Immunosupressive therapy
- Prior ankle fusion or revision of total ankle replacement
- High demanding sport activities (e.g., contact sports, jumping)
- Suspected or documented metal allergy or intolerance
- Condition or situation which, in the Physician's opinion, puts the subject at significant risk, or may interfere significantly with the subject's participation in the study
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT04770870
Start Date
February 1 2022
End Date
April 1 2029
Last Update
June 25 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, United States, 91345
2
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States, 34233
3
Paley Orthopedic & Spine Institute
West Palm Beach, Florida, United States, 33407
4
Orthopaedic Associates
Evansville, Indiana, United States, 47710