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A 3D-Printed bone replica could save the ankle joint

NCT ID NCT05364606

Symptom relief Sponsor: Paragon 28 Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Avascular necrosis of the talus happens when the ankle bone loses its blood supply and collapses. Researchers are testing a custom-made implant shaped like the patient's own talus to replace the damaged bone. The study follows 50 adults for five years to see whether the implant reduces pain and lowers the chance of needing another operation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a custom-made implant that replaces the damaged ankle bone
What this could lead to
If it works, people with a dying ankle bone could avoid fusion or amputation and keep a working joint.
What could go wrong
The implant may loosen, wear down, or fail to relieve pain, and some participants may still need more surgery. The study follows only 50 people, so results may not apply to everyone.

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

About 50 people

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

Started

Jul 2022

Expected to finish

Nov 2033

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

Patients with Avascular Necrosis of the Ankle Joint.

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: 1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol; 2. Avascular necrosis of the ankle joint; 3. Age 21 years old or older; 4. Subject has good general health; and 5. Subject signs a written informed consent form (ICF) prior to the surgical procedure. Exclusion Criteria: 1. Presence of any contraindication identified in the device Instructions for Use; 2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions); 3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure; 4. For female subjects, pregnancy; 5. Active systemic disease, such as AIDS, HIV, or active infection; 6. Active infection or the skin is compromised at the surgical site; and 7. Systemic disease that would affect the subject's welfare; 8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results; 9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up. 10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient. 11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.

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Conditions

The condition(s) this trial relates to.

avascular necrosis osteonecrosis

As listed by the trial registrant

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

Avascular necrosis of the talus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fort Wayne Orthopedics

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mercy Institute for Foot & Ankle Reconstruction

    RECRUITING

    Baltimore, Maryland, 21202, United States

  • Sutter Health Santa Rosa

    RECRUITING

    Santa Rosa, California, 95403, United States

  • UT Physicians Orthopedics - Pearland

    RECRUITING

    Pearland, Texas, 77584, United States

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