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OpenTrials
Completed

NCT Number: NCT02800434

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

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

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Key information

Conditions

Amputation

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Urologie et Chirurgie de la Transplantion

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hand allograft

Procedure

Primary outcomes

  1. fMRI for evaluation of brain plasticity after transplant

    Time frame: 1 year

    Evaluation of brain plasticity after transplant

Secondary outcomes

  1. Rejection

    Time frame: Every 6 months following graft up to 5 years

  2. Adverse events

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2000
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2016
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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