Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Osteoarthritis Ankle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04770870
• Other study ID #: PAS 002
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 2029

Study information

• Verified date: March 2024
• Source: DT MedTech, LLC
• Contact: Clinical Research Associate
• Phone: 3478223603
• Email: amckibbin[@]msquaredassociates.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The H3 TAR device has not been withdrawn from marketing for any reason.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	New Mexico Bone and Joint Institute	Alamogordo	New Mexico
United States	Department of Orthopedic Surgery, Johns Hopkins Outpatient Center	Baltimore	Maryland
United States	MUSC Department of Orthopaedics/Foot and Anke Services	Charleston	South Carolina
United States	Orthopaedic Associates	Evansville	Indiana
United States	Spring Branch Podiatry, PLLC	Houston	Texas
United States	Los Angeles Institute of Foot and Ankle Surgery	Mission Hills	California
United States	Duke Orhtopaedics Arringdon	Morrisville	North Carolina
United States	Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma	Oklahoma City	Oklahoma
United States	Florida Orthopedic Foot & Ankle Center	Sarasota	Florida
United States	Paley Orthopedic & Spine Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
DT MedTech, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Measurement	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	Primary Effectiveness Measurement	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