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New ankle implant tracked for 10 years in 500 arthritis patients

NCT ID NCT03063593

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study follows 500 people who received the INFINITY total ankle replacement to see how well the implant holds up over 10 years. Participants have ankle arthritis from rheumatoid arthritis, injury, or wear-and-tear. Researchers will measure implant survival and changes in pain, function, and quality of life using questionnaires.

What this could mean

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

Active substance
INFINITY Total Ankle System (artificial ankle joint implant)
What this could lead to
If successful, this study could confirm that the INFINITY ankle replacement is a reliable long-term option for people with severe ankle arthritis, potentially improving pain and mobility for many years.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the implant is better than other treatments. Results depend on patient follow-up, and some implants may fail over time, requiring revision 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.

Participants

About 500 people

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

Started

Apr 2016

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.

Who is studied

Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System

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: Subjects to be included in the study must meet all of the following criteria: * Be 21 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 / witnessed verbal consent) Willing and able to attend the requested follow-up visits; * Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following 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 Degenerative arthritis Post-traumatic osteoarthritis

Contacts and locations

Locations

  • North Bristol NHS Trust Southmead Hospital

    Bristol, BS105NB, United Kingdom

  • North Tyneside General Hospital

    Newcastle upon Tyne, NE29 8NH, United Kingdom

  • Nottingham University Hospitals NHS Trust

    Nottingham, United Kingdom, NG5 1PB, United Kingdom

  • RJAH Orthopaedic Hospital

    Oswestry, Shropshire, SY10 7AG, United Kingdom

  • Royal Bournemouth Hosptial

    Bournemouth, Dorset, BH7 7DW, United Kingdom

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW, United Kingdom

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA, United Kingdom

  • Royal National Orthopaedic Hospital

    Middlesex, HA7 4LP, United Kingdom

  • Sheffield Teaching Hospital

    Sheffield, South Yorksire, S5 7AU, United Kingdom

  • Torbay Hospital

    Torquay, Devon, TQ2 7AA, United Kingdom

  • University Hairmyres Hospital

    Bothwell, Scotland, G71 8BB, United Kingdom

  • Wrightington Hospital

    Wigan, WN6 9EP, United Kingdom

More trials for these conditions

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