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

Not Applicable

Completed

• Conditions: Amputation
• Interventions: Procedure: hand allograft

• Registration Number: NCT02800434
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hand allograft	hand allograft	-

Primary Outcome Measures

Name	Time	Method
fMRI for evaluation of brain plasticity after transplant	1 year	Evaluation of brain plasticity after transplant

Secondary Outcome Measures

Name	Time	Method
Adverse events	5 years
Rejection	Every 6 months following graft up to 5 years

Trial Locations

Locations (1)

Service d'Urologie et Chirurgie de la Transplantion; 🇫🇷 Lyon, France