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Can a side approach to ankle replacement stand the test of a decade?

NCT ID NCT07732153

Disease control Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

Ankle arthritis can make walking painful. This study checks whether a specific type of ankle replacement, done through a side incision, still works well after at least 10 years. Researchers will measure how many implants survive and how patients feel and function long-term.

What this could mean

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

Active substance
total ankle replacement surgery using a lateral transfibular approach with a Zimmer TM prosthesis
What this could lead to
If successful, this could confirm that a newer surgical approach for ankle replacement provides lasting relief and mobility for people with ankle arthritis.
What could go wrong
This is a small, single-center study with no comparison group, so results may not apply to all patients or other surgical techniques.

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

61 people

The number who actually took part.

Started

Jun 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 affected by end-stage ankle osteoarthritis treated with total ankle replacement via a transfibular approach between April 2013 and April 2016 at the Galeazzi Orthopedic Institute in Milan. Follow-up visit data will be collected for the period from January 2013 to April 2026.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Adult patients who underwent total ankle replacement at the IRCCS Galeazzi-Sant'Ambrogio Hospital (formerly Galeazzi Orthopedic Institute) between April 2013 and April 2016 via a transfibular lateral approach with a Zimmer TM prosthesis implant and a minimum follow-up of 10 years Exclusion Criteria: * Revision joint replacements * Previous tibiotalar arthrodesis * Inability to retrieve follow-up data.

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As listed by the trial registrant

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

Total ankle arthroplasty surviviorship

Contacts and locations

Locations

  • IRCCS Ospedale Galeazzi Sant'Ambrogio

    Milan, 20100, Italy