Actively Recruiting
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Led by Hospices Civils de Lyon · Updated on 2024-05-08
40
Participants Needed
11
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Double amputation of both forearms
- For transplant group: at least 3 months since amputation
- For transplant group: no psychiatric history that contraindicates graft and psychological maturity confirmed by two psychiatrists
- For transplant group: no history of malignant tumor in remission for less than 5 years
- For transplant group: American Society of Anesthesiology (ASA) score of 2 or less
- For transplant group: New York Heart Association (NYHA) grade 1 or higher
- For transplant group: creatinine clearance of at least 60 ml/min/1.73m²
- For transplant group: no poorly controlled severe hypertension
You will not qualify if you...
- Patients with only one amputated limb
- Malignant tumor or history of malignant tumor with a risk of recurrence greater than 5% within 5 years
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
Berck, France, 62600
Actively Recruiting
2
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
Bruges, France, 33520
Actively Recruiting
3
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
Clamart, France, 92140
Actively Recruiting
4
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
Lille, France, 59260
Actively Recruiting
5
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
Lyon, France, 69005
Actively Recruiting
6
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France, 69427
Actively Recruiting
7
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
Miribel, France, 01700
Actively Recruiting
8
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
Nancy, France, 54042
Actively Recruiting
9
Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
Ploemeur, France, 56275
Actively Recruiting
10
Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon
Saint-Genis-Laval, France, 69230
Actively Recruiting
11
Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné
Valenton, France, 94460
Actively Recruiting
Research Team
L
Lionel BADET, M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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