Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms (ARMEDIC)
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|ClinicalTrials.gov Identifier: NCT02797457|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : January 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Traumatic Amputation of Upper Limbs||Procedure: Bilateral allograft of the hands and forearms. Procedure: Prosthetic forehands||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||October 16, 2026|
|Estimated Study Completion Date :||October 16, 2026|
Bilateral allograft of the hands and forearms.
Procedure: Bilateral allograft of the hands and forearms.
Bilateral allograft of the hands and forearms.
Procedure: Prosthetic forehands
- Treatment cost [ Time Frame: 36 months ]Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797457
|Contact: Lionel BADET, M||4 72 11 91 91 ext +email@example.com|
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