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NCT04770870 | RECRUITING | Osteoarthritis Ankle

Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Sponsor:

DT MedTech, LLC

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), 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.

Condition or disease

Osteoarthritis Ankle

Post-Traumatic Osteoarthritis of Ankle

Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)

Intervention/treatment

Hintermann Series H3 Total Ankle Replacement System

Phase

NA

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 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 The H3 TAR device has not been withdrawn from marketing for any reason.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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 232 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
Actual Study Start Date : 2022-02-01
Estimated Primary Completion Date : 2029-04
Estimated Study Completion Date : 2029-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Location Details

NCT04770870

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Los Angeles Institute of Foot and Ankle Surgery

Mission Hills, California, United States, 91345

RECRUITING

United States, Florida

Florida Orthopedic Foot & Ankle Center

Sarasota, Florida, United States, 34233

RECRUITING

United States, Florida

Paley Orthopedic & Spine Institute

West Palm Beach, Florida, United States, 33407

RECRUITING

United States, Indiana

Orthopaedic Associates

Evansville, Indiana, United States, 47710

RECRUITING

United States, Maryland

Department of Orthopedic Surgery, Johns Hopkins Outpatient Center

Baltimore, Maryland, United States, 21287

RECRUITING

United States, New Mexico

New Mexico Bone and Joint Institute

Alamogordo, New Mexico, United States, 88310

RECRUITING

United States, North Carolina

Duke Orhtopaedics Arringdon

Morrisville, North Carolina, United States, 27560

TERMINATED

United States, Oklahoma

Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

RECRUITING

United States, South Carolina

MUSC Department of Orthopaedics/Foot and Anke Services

Charleston, South Carolina, United States, 29425

RECRUITING

United States, Texas

Spring Branch Podiatry, PLLC

Houston, Texas, United States, 77024