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ACTIVE NOT RECRUITING
NCT07364266

Analgesic Amputation for Algodystrophy: Feedback From a Case Series

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

Summary

What is the aim of the research? The study aims to describe the time interval between amputation for post-traumatic complex regional pain syndrome (CRPS) and functional prosthetic fitting of the amputated limb, within a series of patients managed in an expert center after failure of conventional treatments, in order to improve knowledge and medical practices in this field. What data are used? The data used in this study come from your medical record. They include administrative information (age, sex, date of hospitalization, department, length of stay), medical information (diagnoses, surgical procedures, operative and consultation reports), follow-up information (functional progress, return to activities, occurrence of complications), rehabilitation and prosthetic fitting information (dates of prosthesis fitting, whether it was accepted or not, functional rehabilitation), and information from pain centers if present in the hospital medical record. These data will be pseudonymized; that is, they will be coded and will not include your first or last name. They will be processed confidentially, only by authorized members of the research team, for exclusively scientific purposes. Who will receive the data? Authorized members of the research team who carry out the analyses will have access to the study data in coordination with the scientific lead. All these individuals are bound by professional secrecy and confidentiality. The results of the analyses will be published in scientific journals or presented at conferences. They will always be reported in aggregate form, so that it will be completely impossible to identify a study participant. How is the study conducted and how is your data security ensured? A computerized file containing only the data strictly necessary for the study will be created within Brest University Hospital (CHU de Brest). Your first and last names will not appear in this file. Only authorized members of the research team will be able to access the data. Access to the database will be secured by an individual password. Analyses will always be carried out confidentially. No individual data will be extracted from the database. The results of the study will help improve current knowledge and optimize the care of patients who may experience the same medical situation as the one you have experienced. Your health data collected as part of this research will be kept and archived for a maximum of 5 years after the end of the study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-09-01

Completion Date

2026-03-31

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

OTHER

describe the time interval between amputation for post-traumatic algodystrophy and functional prosthetic fitting of the amputated limb

Primary objective endpoint: time interval, expressed in days, between the date of the amputation surgery and the date of the first effective fitting of a functional prosthesis, as documented in the medical record or during follow-up consultations.

Locations (2)

Chu Brest

Brest, France

CHU de Brest

Brest, France