Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Last updated: June 24, 2024
Sponsor: DT MedTech, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Osteoarthritis

Treatment

Hintermann Series H3 Total Ankle Replacement System

Clinical Study ID

NCT04770870
PAS 002
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Each potential subject must be an appropriate candidate for mobile bearing TAR byhaving: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritissecondary 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

Exclusion Criteria:

  • Skeletal immaturity

  • Bone stock inadequate to support the device including:

  • Severe osteoporotic or osteopenic condition or other conditions resulting inpoor 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 structuresincluding:

  • Hindfoot or forefoot malalignment precluding plantigrade foot

  • Significant malalignment of the knee joint

  • Insufficient ligament support that cannot be repaired with soft tissuestabilization (syndesmosis disruption)

  • Charcot joint or peripheral neuropathy that may lead to Charcot joint of theaffected ankle

  • Neuromuscular disease resulting in lack of normal muscle function about the affectedankle

  • 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 atsignificant risk, or may interfere significantly with the subject's participation inthe study

Study Design

Total Participants: 232
Treatment Group(s): 1
Primary Treatment: Hintermann Series H3 Total Ankle Replacement System
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
April 30, 2029

Study 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.

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.

Connect with a study center

  • Phoenix Foot and Ankle Institute

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Los Angeles Institute of Foot and Ankle Surgery

    Mission Hills, California 91345
    United States

    Active - Recruiting

  • Florida Orthopedic Foot & Ankle Center

    Sarasota, Florida 34233
    United States

    Active - Recruiting

  • Paley Orthopedic & Spine Institute

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Orthopaedic Associates

    Evansville, Indiana 47710
    United States

    Active - Recruiting

  • Department of Orthopedic Surgery, Johns Hopkins Outpatient Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • New Mexico Bone and Joint Institute

    Alamogordo, New Mexico 88310
    United States

    Active - Recruiting

  • Duke Orhtopaedics Arringdon

    Morrisville, North Carolina 27560
    United States

    Active - Recruiting

  • Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Terminated

  • MUSC Department of Orthopaedics/Foot and Anke Services

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Spring Branch Podiatry, PLLC

    Houston, Texas 77024
    United States

    Active - Recruiting

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