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

NCT ID: NCT02800434

Last Updated: 2025-09-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2021-12-10

Brief Summary

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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

Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hand allograft

Group Type EXPERIMENTAL

hand allograft

Intervention Type PROCEDURE

Interventions

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hand allograft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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.

Reference Type BACKGROUND
PMID: 24646555 (View on PubMed)

Other Identifiers

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99-176

Identifier Type: -

Identifier Source: org_study_id

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