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

April 15, 2025 updated by: Institut Robert Merle d'aubigné
The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Valenton, France
        • Institut Robert Merle d'Aubigné

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient treated at the institut Rober Merle d'Aubigné

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with ATCT
Patient with tibiocalcaneal arthrodesis with talectomy amputation
Other: Questionnary
Data from theses patients will be collected in our personnal data base with ask of consent according to the law Then each patient alive will have questionnary to answer by phone or during a visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The possibility of walking without a prosthesis
Time Frame: Immediatly after inclusion
Yes / No
Immediatly after inclusion
Walking perimeter with prosthesis
Time Frame: Immediatly after inclusion
In meters
Immediatly after inclusion
Number of re-amputation since first amputation
Time Frame: Immediatly after inclusion
Immediatly after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Robert Merle d'aubigné

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

June 1, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00393-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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