Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

Last updated: May 7, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Bilateral allograft of the hands and forearms.

Prosthetic forehands

Clinical Study ID

NCT02797457
69HCL15_0084
  • Ages 18-60
  • All Genders

Study 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 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, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.

The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.

A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.

Eligibility Criteria

Inclusion

Inclusion Criteria: Inclusion criteria common to the 2 groups of patients (allograft group and prothesesgroup):

  • 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 psychologicalmaturity, 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

Exclusion Criteria:

  • Mono amputated patients
  • Malignant tumor or previous history of malignant tumor for which the risk ofrecurrence at 5 years is greater than 5%

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Bilateral allograft of the hands and forearms.
Phase:
Study Start date:
October 16, 2018
Estimated Completion Date:
October 16, 2031

Connect with a study center

  • Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale

    Berck, 62600
    France

    Active - Recruiting

  • Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies

    Bruges, 33520
    France

    Active - Recruiting

  • Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy

    Clamart, 92140
    France

    Active - Recruiting

  • Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir

    Hellemmes, 59260
    France

    Site Not Available

  • Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir

    Lille, 59260
    France

    Active - Recruiting

  • Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues

    Lyon, 69005
    France

    Active - Recruiting

  • Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon

    Lyon, 69427
    France

    Active - Recruiting

  • Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari

    Miribel, 01700
    France

    Active - Recruiting

  • Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation

    Nancy, 54042
    France

    Active - Recruiting

  • Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape

    Ploemeur, 56275
    France

    Active - Recruiting

  • Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon

    Saint-Genis-Laval, 69230
    France

    Active - Recruiting

  • Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné

    Valenton, 94460
    France

    Active - Recruiting

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