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

NCT ID NCT04770870

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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.