Bilateral allograft of the hands and forearms.
ProcedureBilateral allograft of the hands and forearms.
NCT Number: NCT02797457
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale, Berck, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
common to the 2 groups of patients (allograft group and protheses group):
Transplant eligibility criteria (for allograft group)
Exclusion criteria
Bilateral allograft of the hands and forearms.
Prosthetic forehands
Time frame: 36 months
Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
Acronym: ARMEDIC
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