Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Description

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.

Conditions

Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)

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Study Overview

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Study Details

Study overview

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.

Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System

Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Condition
Osteoarthritis Ankle
Intervention / Treatment

-

Contacts and Locations

Mission Hills

Los Angeles Institute of Foot and Ankle Surgery, Mission Hills, California, United States, 91345

Sarasota

Florida Orthopedic Foot & Ankle Center, Sarasota, Florida, United States, 34233

West Palm Beach

Paley Orthopedic & Spine Institute, West Palm Beach, Florida, United States, 33407

Evansville

Orthopaedic Associates, Evansville, Indiana, United States, 47710

Baltimore

Department of Orthopedic Surgery, Johns Hopkins Outpatient Center, Baltimore, Maryland, United States, 21287

Alamogordo

New Mexico Bone and Joint Institute, Alamogordo, New Mexico, United States, 88310

Morrisville

Duke Orhtopaedics Arringdon, Morrisville, North Carolina, United States, 27560

Oklahoma City

Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma, Oklahoma City, Oklahoma, United States, 73104

Charleston

MUSC Department of Orthopaedics/Foot and Anke Services, Charleston, South Carolina, United States, 29425

Houston

Spring Branch Podiatry, PLLC, Houston, Texas, United States, 77024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

DT MedTech, LLC,

Study Record Dates

2029-04