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)
Primary Safety Measurement — 5-years The Primary Safety Measurement for this study is the percentage of patient subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Primary Effectiveness Measurement — 5-years The co-primary effectiveness measurements for this study are the American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more, the survivorship (absence of removal/revisions of metal components) within 5 years post-surgery, and the percentage of subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Trial sites (11)
Facility
City
Region
Status
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.
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