FDA-Approved ankle replacement under the microscope: will it hold up?
NCT ID NCT04770870
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 94 people who received the FDA-approved H3 total ankle replacement for arthritis. Researchers will track serious device-related problems and how well the ankle works over 2 to 5 years. The goal is to confirm the device's safety and effectiveness in real-world use.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Hintermann Series H3 Total Ankle Replacement System (a device with metal and plastic parts to replace the ankle joint)
What this could lead to
If successful, this study could confirm that the H3 ankle replacement is a safe and effective option for people with severe ankle arthritis, helping them move with less pain.
What could go wrong
This is a post-approval study, not a new treatment test. It mainly tracks safety and device survival, so it won't prove a cure. Some patients may still need revision surgery or have complications.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Christus St Vincent
Alamogordo, New Mexico, 88310, United States
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Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
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Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
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Duke Orhtopaedics Arringdon
Morrisville, North Carolina, 27560, United States
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Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, 34233, United States
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Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, 91345, United States
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MUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina, 29425, United States
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Ortho Arkansas
Little Rock, Arkansas, 72204, United States
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Orthopaedic Associates
Evansville, Indiana, 47710, United States
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Paley Orthopedic & Spine Institute
West Palm Beach, Florida, 33407, United States
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Spring Branch Podiatry, PLLC
Houston, Texas, 77024, United States