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New ankle implant tracked for 10 years: will it hold up?

NCT ID NCT02038140

Disease control Sponsor: Zimmer Biomet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study follows 120 adults who received the Zimmer Trabecular Metal Total Ankle implant to treat severe arthritis (degenerative, rheumatoid, or post-traumatic). Researchers will check how long the implant lasts, pain levels, and quality of life over 10 years. The goal is to see if this metal ankle replacement is a safe and effective long-term solution.

What this could mean

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

Active substance
Zimmer Trabecular Metal Total Ankle implant (a metal ankle replacement device)
What this could lead to
If successful, this could confirm that the Zimmer Trabecular Metal Total Ankle is a reliable long-term option for people with severe ankle arthritis, reducing pain and improving mobility.
What could go wrong
This is an observational follow-up study, not a controlled trial, so results may not prove the device is better than other options. Some patients may experience implant failure or complications requiring additional surgery.

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 120 people

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

Start date

Mar 2014

Expected to finish

Dec 2027

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

18 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: * The patient is \> 18 years of age * The patient is skeletally mature * The patient qualifies for primary or revision total ankle replacement based on physical exam and medical history including the following: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis. * The patient is willing and able to provide written informed consent * Patient is willing and able to cooperate in the required post-operative therapy * The patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the Informed Consent * The patient has participated in the Informed Consent process and has signed the Institutional Review Board/European Commission approved Informed Consent Exclusion Criteria: * The patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcohol or drug abuser, anticipated to be non-compliant. * The patient has one of the following compromising the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery. * The patient has a local/systemic infection that may affect the prosthetic joint * The patient has a previous history of infection in the affected joint * The patient is known to be pregnant * The patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, Charcot's disease) * The patient has a known sensitivity or allergic reaction to one or more of the implanted materials * The patient is unwilling or unable to give consent or to comply with the follow-up program

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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.

Degenerative arthritis Post traumatic arthritis Rheumatoid arthritis

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27705-4677, United States

  • Humanitas San Pio X

    Milan, Milano MI, 20159, Italy

  • Inselspital-Stiftung Universitatsspital Bern

    Bern, 3010, Switzerland

  • Klinikverbund St. Antonius und St. Josef GmbH

    Wuppertal, Germany

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Orthopaedic Associates of Grand Rapids REI

    Grand Rapids, Michigan, 49503, United States

  • Spital StS AG

    Thun, Switzerland

  • The Rothman Institute

    Philadelphia, Pennsylvania, 19107, United States

  • Turku University Hospital Finland

    Turku, Finland

  • UBC Providence Health Care Research Institute

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • University California Davis

    Sacramento, California, 95817, United States

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