Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE January 2000
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
fMRI for evaluation of brain plasticity after transplant [ Time Frame: 1 year ]
Evaluation of brain plasticity after transplant
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Rejection [ Time Frame: Every 6 months following graft up to 5 years ]
  • Adverse events [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
Official Title  ICMJE Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amputation
Intervention  ICMJE Procedure: hand allograft
Study Arms  ICMJE Experimental: hand allograft
Intervention: Procedure: hand allograft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 14, 2016)
7
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800434
Other Study ID Numbers  ICMJE 99-176
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lionel BADET Hospices Civils de Lyon - Service d'Urologie et Chirurgie de la Transplantion
PRS Account Hospices Civils de Lyon
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP