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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800434
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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


Condition or disease Intervention/treatment Phase
Amputation Procedure: hand allograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
Actual Study Start Date : January 2000
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: hand allograft Procedure: hand allograft



Primary Outcome Measures :
  1. fMRI for evaluation of brain plasticity after transplant [ Time Frame: 1 year ]
    Evaluation of brain plasticity after transplant


Secondary Outcome Measures :
  1. Rejection [ Time Frame: Every 6 months following graft up to 5 years ]
  2. Adverse events [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800434


Locations
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France
Service d'Urologie et Chirurgie de la Transplantion
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Lionel BADET Hospices Civils de Lyon - Service d'Urologie et Chirurgie de la Transplantion
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02800434    
Other Study ID Numbers: 99-176
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
allograft
hands
immunosuppression
fMRI