Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases

September 8, 2025 updated by: Hospices Civils de Lyon

The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.

The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.

The objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

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
      • Lyon, France, 69003
        • Service d'Urologie et Chirurgie de la Transplantion

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • double amputated patients
  • minimum of 3 months and maximum of 3 years interval between amputation and graft
  • adult aged 20 to 40 years
  • psychological maturity
  • written informed consent

Exclusion Criteria:

  • mono amputated patients
  • previous history of malignant tumor in remission for less than 5 years,
  • malignant tumor
  • previous psychiatric history
  • American Society of Anesthesiology (ASA) score >2
  • New York Heart Association (NYHA) >1
  • nenal insufficiency
  • severe hypertension

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hand allograft
Procedure: hand allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI for evaluation of brain plasticity after transplant
Time Frame: 1 year
Evaluation of brain plasticity after transplant
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 5 years
5 years
Rejection
Time Frame: Every 6 months following graft up to 5 years
Every 6 months following graft up to 5 years

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Lionel BADET, Hospices Civils de Lyon - Service d'Urologie et Chirurgie de la Transplantion

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)

January 1, 2000

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 15, 2016

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 99-176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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