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Clinical Trials in the USA / NCT04770870
Active, not recruiting Not applicable

Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

NCT04770870 · tracked via the Priya Life Science USA tracker
Sponsor
DT MedTech, LLC
Phase
Not applicable
Started
2022-02-01
Last updated
2026-06-22

Condition(s) studied

Osteoarthritis AnklePost-Traumatic Osteoarthritis of AnkleOsteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)

Investigational drug(s) / intervention(s)

Hintermann Series H3 Total Ankle Replacement System

Hintermann Series H3 Total Ankle Replacement System: Intervention will include receiving the FDA approved Hintermann Series H3 Total Ankle Replacement System, to include a tibial component, a polyethylene inlay, and a talar component.

Study 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), 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Ortho Arkansas Little Rock Arkansas
Los Angeles Institute of Foot and Ankle Surgery Mission Hills California
Florida Orthopedic Foot & Ankle Center Sarasota Florida
Paley Orthopedic & Spine Institute West Palm Beach Florida
Orthopaedic Associates Evansville Indiana
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center Baltimore Maryland
Christus St Vincent Alamogordo New Mexico
Duke Orhtopaedics Arringdon Morrisville North Carolina
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma Oklahoma City Oklahoma
MUSC Department of Orthopaedics/Foot and Anke Services Charleston South Carolina
Spring Branch Podiatry, PLLC Houston Texas
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04770870 on ClinicalTrials.gov ↗ ← All trials in the USA