Analgesic Amputation for Algodystrophy: Feedback From a Case Series

NCT07364266 | Active Not Recruiting

• 1 other identifier: 29BRC25.0239 - AMPUTALGO
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Algoneurodystrophy; Amputation

Outcome Measures

Primary Outcomes (1)

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

  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.

  2010 to 2025

Secondary Outcomes (1)

• Assess the time interval between amputation and return to a physical or leisure activity, in order to better understand the medium-term functional impact after amputation for algodystrophy.

  2010 to 2025

Study Arms (1)

amputation for algodystrophy

A population of patients who underwent lower- or upper-limb amputation for post-traumatic algodystrophy, managed at Brest University Hospital (CHRU de Brest) between 2010 and 2025. \*\*Inclusion criteria:\*\* * Adult patients at the time of amputation; * Post-traumatic algodystrophy diagnosed clinically and confirmed by imaging if necessary, according to the \*\*Budapest criteria\*\*; * Amputation performed for analgesic purposes after failure of conventional medical and rehabilitation treatments; * Postoperative follow-up performed at \*\*CHRU de Brest\*\*, with available data on prosthetic fitting and postoperative activities; * Complete medical record accessible via the hospital electronic medical record.

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

Interventions

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

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.

amputation for algodystrophy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study concerns a population of patients who underwent lower- or upper-limb amputation for post-traumatic algodystrophy, managed at CHRU de Brest between 2010 and 2025. This rare and specific indication relies on a multidisciplinary medical decision after a prolonged pathway in a pain center, justifying rigorous and homogeneous population selection.

You may qualify if:

• Adult patients at the time of amputation; Post-traumatic algodystrophy diagnosed clinically and confirmed by imaging if necessary, according to the Budapest criteria; Amputation performed for analgesic purposes, after failure of conventional medical and rehabilitation treatments; Postoperative follow-up carried out at CHRU de Brest, with available data on prosthetic fitting and postoperative activities; Complete medical record accessible via the hospital electronic medical record.

You may not qualify if:

• Patients amputated for another cause (vascular, tumor, infectious, etc.); Patients not followed after amputation or immediately lost to follow-up after surgery; Incomplete medical records regarding the main variables of interest (dates of amputation, prosthetic fitting, functional follow-up).

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Chu Brest

Brest, 29200, France

Location

CHU de Brest

Brest, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 23, 2026
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (2)