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Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

RecruitingNAAges 18 Years - 60 YearsAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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 sensitivity , 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. Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities,

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📋 Eligibility rules (as published)
Inclusion Criteria: Inclusion criteria common to the 2 groups of patients (allograft group and protheses group): * Adult aged 18 to 60 years * Double amputated of both forearms Transplant eligibility criteria (for allograft group) * Minimum interval between amputation and graft of three months (no maximal delay) * Absence of previous psychiatric history contraindicating the graft and psychological maturity, according to two psychiatrists who have evaluated the patient * No previous history of malignant tumor in remission for less than 5 years * American Society of Anesthesiology (ASA) score ≤ 2 * New York Heart Association (NYHA) grade ≥ 1 * Creatinine clearance ≥ 60 ml/min/1.73m² * Absence of badly controlled sever hypertension Exclusion Criteria: * Mono amputated patients * Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
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What it tests

  • Bilateral allograft of the hands and forearms.
  • Prosthetic forehands
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Where

11 sites
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
Berck, France
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
Bruges, France
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
Clamart, France
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
Lille, France
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
Lyon, France
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
Miribel, France
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
Nancy, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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