Overview

This trial is active, not recruiting.

Condition amputation
Treatment hand allograft
Sponsor Hospices Civils de Lyon
Start date January 2000
End date October 2020
Trial size 7 participants
Trial identifier NCT02800434, 99-176

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
hand allograft

Primary Outcomes

Measure
fMRI for evaluation of brain plasticity after transplant
time frame: 1 year

Secondary Outcomes

Measure
Rejection
time frame: Every 6 months following graft up to 5 years
Adverse events
time frame: 5 years

Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

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

Additional Information

Official title Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
Principal investigator Lionel BADET
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.