WithdrawnNot Applicable

Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Belgium, France, Italy0

Plain-language summary

In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis. The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty * Patient receiving CE marked medical devices and planned to be operated in compliance with their respective Instructions for Use * Patient aged between 40 and 75 years old Exclusion Criteria: * Patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle * Patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint) * Patient with ankle deformity \> 20° (weight bearing X-rays) * Patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture) * Patient with neuropathy or with a history of diabetes mellitus for more than 15 years * Patient with avascular necrosis of the talus \>25% * Patient already included in the study for the other ankle

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm

Timeframe: after 5 years of follow-up

Trial details

NCT IDNCT02025946

SponsorIntegra LifeSciences Services

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-01

View on ClinicalTrials.gov More Arthritis trials