Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

NCT04770870 | Active Not Recruiting FDA Device

• 1 other identifier: PAS 002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 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

Study Arms (1)

Treatment Arm

OTHER

All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.

Device: Hintermann Series H3 Total Ankle Replacement System

Interventions

Hintermann Series H3 Total Ankle Replacement System DEVICE

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.

Treatment Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DT MedTech, LLC: lead

Study Sites (11)

Ortho Arkansas

Little Rock, Arkansas, 72204, United States

Location

Los Angeles Institute of Foot and Ankle Surgery

Mission Hills, California, 91345, United States

Location

Florida Orthopedic Foot & Ankle Center

Sarasota, Florida, 34233, United States

Location

Paley Orthopedic & Spine Institute

West Palm Beach, Florida, 33407, United States

Location

Orthopaedic Associates

Evansville, Indiana, 47710, United States

Location

Department of Orthopedic Surgery, Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Christus St Vincent

Alamogordo, New Mexico, 88310, United States

Location

Duke Orhtopaedics Arringdon

Morrisville, North Carolina, 27560, United States

Location

Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

MUSC Department of Orthopaedics/Foot and Anke Services

Charleston, South Carolina, 29425, United States

Location

Spring Branch Podiatry, PLLC

Houston, Texas, 77024, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single arm post approval study of 94 US subjects up to 10 US study sites

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)