Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

DT MedTech

Status

Enrolling

Conditions

Post-Traumatic Osteoarthritis of Ankle

Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)

Osteoarthritis Ankle

Treatments

Device: Hintermann Series H3 Total Ankle Replacement System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04770870

PAS 002

Details and patient eligibility

About

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.

Full 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 osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.).

The present version (third generation) of the H3 TAR and the earlier generations of this total ankle system have been marketed (initially in 2003) under a license agreement in Europe, South Korea, Australia, and Canada and other countries outside the U.S. (OUS). The H3 TAR prosthesis has been used in over 20,000 procedures in the markets OUS. The H3 TAR device has not been withdrawn from marketing for any reason.

Enrollment

232 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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