Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
NCT ID: NCT02800434
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2000-01-31
2021-12-10
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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hand allograft
hand allograft
Interventions
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hand allograft
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
40 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Lionel BADET
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon - Service d'Urologie et Chirurgie de la Transplantion
Locations
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Service d'Urologie et Chirurgie de la Transplantion
Lyon, , France
Countries
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References
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Petruzzo P, Gazarian A, Kanitakis J, Parmentier H, Guigal V, Guillot M, Vial C, Dubernard JM, Morelon E, Badet L. Outcomes after bilateral hand allotransplantation: a risk/benefit ratio analysis. Ann Surg. 2015 Jan;261(1):213-20. doi: 10.1097/SLA.0000000000000627.
Other Identifiers
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99-176
Identifier Type: -
Identifier Source: org_study_id
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