Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
NCT ID: NCT02797457
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2018-10-16
2031-10-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Allograft
Bilateral allograft of the hands and forearms.
Bilateral allograft of the hands and forearms.
Bilateral allograft of the hands and forearms.
Prostheses
Prosthetic forehands
Prosthetic forehands
Prosthetic forehands
Interventions
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Bilateral allograft of the hands and forearms.
Bilateral allograft of the hands and forearms.
Prosthetic forehands
Prosthetic forehands
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
18 Years
60 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
Berck, , France
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
Bruges, , France
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
Clamart, , France
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
Lille, , France
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
Lyon, , France
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, , France
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
Miribel, , France
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
Nancy, , France
Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
Ploemeur, , France
Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon
Saint-Genis-Laval, , France
Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné
Valenton, , France
Countries
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Central Contacts
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Facility Contacts
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Frédéric CHARLATE, MD
Role: primary
Rémi KLOTZ, MD
Role: primary
Eric LAPEYRE, MD
Role: primary
Hervé DELAHAYE, MD
Role: primary
Isabelle LAROYENNE, MD
Role: primary
Lionel BADET, MD
Role: primary
Renaud TAVERNIER, MD
Role: primary
Jean PAYSANT, MD
Role: primary
Pierre VERSCHOORE, MD
Role: primary
Gilles RODE, MD
Role: primary
Florence GUILLOU, MD
Role: primary
Other Identifiers
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69HCL15_0084
Identifier Type: -
Identifier Source: org_study_id
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