Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

June 24, 2024 updated by: DT MedTech, LLC

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 The H3 TAR device has not been withdrawn from marketing for any reason.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

Enrollment (Estimated)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: In House Clinical Research Associate
  • Phone Number: 202.742.3869
  • Email: pwlasiuk@mcra.com

Study Contact Backup

Study Locations

  • United States
    • California
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Los Angeles Institute of Foot and Ankle Surgery
        • Principal Investigator:
          • Armen Hagopjanian, DPM
        • Contact:
    • Florida
      • Sarasota, Florida, United States, 34233
        • Recruiting
        • Florida Orthopedic Foot & Ankle Center
        • Principal Investigator:
          • James Cottom, MD
        • Contact:
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Paley Orthopedic & Spine Institute
        • Contact:
        • Principal Investigator:
          • Bradley Lamm, DPM
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Recruiting
        • Orthopaedic Associates
        • Contact:
        • Principal Investigator:
          • Charles A. Sisovsky, DPM
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
        • Principal Investigator:
          • James Ficke, MD
        • Contact:
    • New Mexico
      • Alamogordo, New Mexico, United States, 88310
        • Recruiting
        • New Mexico Bone and Joint Institute
        • Contact:
        • Principal Investigator:
          • John J Anderson, DPM
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Duke Orhtopaedics Arringdon
        • Principal Investigator:
          • James Nunley, MD
        • Sub-Investigator:
          • Mark Easley, MD
        • Sub-Investigator:
          • Samuel Adams, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Terminated
        • Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • MUSC Department of Orthopaedics/Foot and Anke Services
        • Principal Investigator:
          • Christopher Gross, MD
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77024
        • Recruiting
        • Spring Branch Podiatry, PLLC
        • Contact:
        • Principal Investigator:
          • Randal Beckman, DPM

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.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment Arm
All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Measurement
Time Frame: 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.
5-years
Primary Effectiveness Measurement
Time Frame: 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.
5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DT MedTech, LLC

Investigators

  • Study Chair: Melanie Tuznik, DT MedTech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAS 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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