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.
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 The H3 TAR device has not been withdrawn from marketing for any reason.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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
232
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.
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, United States
RECRUITINGFlorida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States
RECRUITINGPaley Orthopedic & Spine Institute
West Palm Beach, Florida, United States
RECRUITINGOrthopaedic Associates
Evansville, Indiana, United States
RECRUITINGDepartment of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
RECRUITINGNew Mexico Bone and Joint Institute
Alamogordo, New Mexico, United States
RECRUITINGDuke Orhtopaedics Arringdon
Morrisville, North Carolina, United States
RECRUITINGDept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma, United States
TERMINATEDMUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina, United States
RECRUITINGSpring Branch Podiatry, PLLC
Houston, Texas, United States
RECRUITINGPrimary 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.
Time frame: 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.
Time frame: 5-years
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