CompletedNot Applicable

Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support

France94 participantsStarted 2024-05-20

Plain-language summary

The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.

Who can participate

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: * Syme or Pirogoff or ATCT or arthrodesized Chopart type amputation * Age \> 18 years old, * First fitting or renewal of Syme type prosthesis delivered to IRMA between January 2008 and December 2018 Exclusion Criteria: * Refusal documented in the file that the data be used for scientific purposes, * Congenital etiology of the condition.

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

The possibility of walking without a prosthesis

Timeframe: Immediatly after inclusion

Walking perimeter with prosthesis

Timeframe: Immediatly after inclusion

Number of re-amputation since first amputation

Timeframe: Immediatly after inclusion

Trial details

NCT IDNCT06448260

SponsorInstitut Robert Merle d'aubigné

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Amputation, Surgical trials

Who can participate

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.