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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02800434
Enrollment
7
Registered
2016-06-15
Start date
2000-01-31
Completion date
2021-12-10
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation

Keywords

allograft, hands, immunosuppression, fMRI

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

Interventions

PROCEDUREhand allograft

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
fMRI for evaluation of brain plasticity after transplant1 yearEvaluation of brain plasticity after transplant

Secondary

MeasureTime frame
RejectionEvery 6 months following graft up to 5 years
Adverse events5 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026