Cure My Disease

Don't miss your cure!

 Log in / Sign up

FDA-Approved ankle replacement under the microscope: will it hold up?

NCT ID NCT04770870

Ongoing Disease control Sponsor: DT MedTech, LLC Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for OSTEOARTHRITIS OF ANKLE SECONDARY TO INFLAMMATORY ARTHRITIS (DISORDER) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

osteoarthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSTEOARTHRITIS OF ANKLE SECONDARY TO INFLAMMATORY ARTHRITIS (DISORDER) OSTEOARTHRITIS, ANKLE POST-TRAUMATIC OSTEOARTHRITIS OF ANKLE

Contacts and locations

Locations

  • Christus St Vincent

    Alamogordo, New Mexico, 88310, United States

  • Department of Orthopedic Surgery, Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287, United States

  • Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • Duke Orhtopaedics Arringdon

    Morrisville, North Carolina, 27560, United States

  • Florida Orthopedic Foot & Ankle Center

    Sarasota, Florida, 34233, United States

  • Los Angeles Institute of Foot and Ankle Surgery

    Mission Hills, California, 91345, United States

  • MUSC Department of Orthopaedics/Foot and Anke Services

    Charleston, South Carolina, 29425, United States

  • Ortho Arkansas

    Little Rock, Arkansas, 72204, United States

  • Orthopaedic Associates

    Evansville, Indiana, 47710, United States

  • Paley Orthopedic & Spine Institute

    West Palm Beach, Florida, 33407, United States

  • Spring Branch Podiatry, PLLC

    Houston, Texas, 77024, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.