Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- fMRI for evaluation of brain plasticity after transplant
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
fMRI for evaluation of brain plasticity after transplant
Time Frame: 1 year
Evaluation of brain plasticity after transplant
Secondary Outcomes
- Adverse events(5 years)
- Rejection(Every 6 months following graft up to 5 years)