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

Civil Hospices of Lyon

Status: Completed

Conditions: Amputation

Treatments: Procedure: hand allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT02800434

99-176

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

hand allograft

Experimental group

Treatment:

Procedure: hand allograft