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New ankle implant tracked for 10 years in arthritis patients

NCT ID NCT04594993

Disease control Sponsor: Stryker Trauma and Extremities 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study follows 200 adults with ankle arthritis who received the INFINITY ankle replacement. Researchers will check how long the implant lasts and monitor for any problems like loosening or cysts over 10 years. The goal is to see if this device works as well as other similar implants.

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.

Participants

200 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Nov 2035

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.

Who is studied

Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ with ADAPTIS™ Technology Total Ankle System

Ages

22 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: * Be over 22 years of age at the time of surgery; * Diagnosed with unilateral and/or bilateral ankle joint disease; * Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; * Willing and able to consent to participate (written, informed consent; * Willing and able to attend the requested follow-up visits; * A clinical decision has been made to use INFINITY™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment. Exclusion Criteria: * Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement; * Subjects requiring revision total ankle replacement of the ankle being considered for study

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Conditions

The condition(s) this trial relates to.

osteoarthritis rheumatoid arthritis

As listed by the trial registrant

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

Arthritis rheumatoid

Contacts and locations

Locations

  • Campbell Clinic

    Germantown, Tennessee, 38138, United States

  • Eisenhower Health / Desert Orthopedic Center

    Rancho Mirage, California, 92270-3221, United States

  • Erlanger Institute for Clinical Research

    Chattanooga, Tennessee, 37403, United States

  • Florida Joint Care Institute

    Trinity, Florida, 34655, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • OrthoArizona Foot and Ankle Institute

    Gilbert, Arizona, 85234, United States

  • Slocum Research & Education Foundation

    Eugene, Oregon, 97401, United States

  • Southern Oregon Orthopedics

    Medford, Oregon, 97504, United States

  • Steadman Philippon Research Institute

    Vail, Colorado, 81567, United States

  • University of Colorado Orthopedic Research Center

    Aurora, Colorado, 80045, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

More trials for these conditions

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