Informations générales (source: ClinicalTrials.gov)
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms (ARMEDIC)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
octobre 2018
octobre 2031
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLINIQUE L ERMITAGE DE CLAMART | Eric LAPEYRE, MD | Contact (sur clinicalTrials) | |||
| CTRE REEDUCATION FONCTIONNELLE EVRY | Renaud TAVERNIER, MD | Contact (sur clinicalTrials) | |||
| INSTITUT ROBERT MERLE D AUBIGNE | Florence GUILLOU, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues - 69005 - Lyon - France | Isabelle LAROYENNE, MD | Contact (sur clinicalTrials) | |||
| Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon - 69230 - Saint-Genis-Laval - France | Gilles RODE, MD | Contact (sur clinicalTrials) | |||
| Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon - 69427 - Lyon - France | Lionel BADET, MD | Contact (sur clinicalTrials) | |||
| Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies - 33520 - Bruges - France | Rémi KLOTZ, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale - 62600 - Berck - France | Frédéric CHARLATE, MD | Contact (sur clinicalTrials) | |||
| Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir - 59260 - Lille - France | Hervé DELAHAYE, MD | Contact (sur clinicalTrials) | |||
| Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape - 56275 - Ploemeur - France | Pierre VERSCHOORE, MD | Contact (sur clinicalTrials) | |||
| Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation - 54042 - Nancy - France | Jean PAYSANT, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
- Mono amputated patients
- Malignant tumor or previous history of malignant tumor for which the risk of
recurrence at 5 years is greater than 5%