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NCT02800434 Clinical Trial

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

Amputation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02800434
Other study ID # 99-176
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2000
Est. completion date December 10, 2021

Study information
Verified date June 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date December 10, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• hand allograft

Locations
Country Name City State
France Service d'Urologie et Chirurgie de la Transplantion Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary fMRI for evaluation of brain plasticity after transplant Evaluation of brain plasticity after transplant 1 year
Secondary Rejection Every 6 months following graft up to 5 years
Secondary Adverse events 5 years
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