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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
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Allograft
Bilateral allograft of the hands and forearms.
Procedure: Bilateral allograft of the hands and forearms.
Bilateral allograft of the hands and forearms.

Prostheses
Prosthetic forehands
Procedure: Prosthetic forehands
Prosthetic forehands




Primary Outcome Measures :
  1. Treatment cost [ Time Frame: 36 months ]
    Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Mono amputated patients
  • Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%

Information from the National Library of Medicine

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


Contacts
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Contact: Lionel BADET, M 4 72 11 91 91 ext +33 lionel.badet@chu-lyon.fr

Locations
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France
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale Not yet recruiting
Berck, France, 62600
Contact: Frédéric CHARLATE, MD         
Principal Investigator: Frédéric CHARLATE, MD         
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies Not yet recruiting
Bruges, France, 33520
Contact: Rémi KLOTZ, MD         
Principal Investigator: Rémi KLOTZ, MD         
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy Not yet recruiting
Clamart, France, 92140
Contact: Eric LAPEYRE, MD         
Principal Investigator: Eric LAPEYRE, MD         
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir Not yet recruiting
Hellemmes, France, 59260
Contact: Hervé DELAHAYE, MD         
Principal Investigator: Hervé DELAHAYE, MD         
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues Not yet recruiting
Lyon, France, 69005
Contact: Isabelle LAROYENNE, MD         
Principal Investigator: Isabelle LAROYENNE, MD         
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon Recruiting
Lyon, France, 69427
Contact: Lionel BADET, MD         
Principal Investigator: Lionel BADET, MD         
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari Not yet recruiting
Miribel, France, 01700
Contact: Michel GUILLOT, MD         
Principal Investigator: Michel GUILLOT, MD         
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation Not yet recruiting
Nancy, France, 54042
Contact: Jean PAYSANT, MD         
Principal Investigator: Jean PAYSANT, MD         
Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape Not yet recruiting
Ploemeur, France, 56275
Contact: Pierre VERSCHOORE, MD         
Principal Investigator: Pierre VERSCHOORE, MD         
Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon Not yet recruiting
Saint-Genis-Laval, France, 69230
Contact: Gilles RODE, MD         
Principal Investigator: Gilles RODE, MD         
Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné Not yet recruiting
Valenton, France, 94460
Contact: Florence GUILLOU, MD         
Principal Investigator: Florence GUILLOU, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02797457     History of Changes
Other Study ID Numbers: 69HCL15_0084
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Bilateral amputation of the forearms
Bilateral allograft
Prosthetic forehands
Medical economic evaluation

Additional relevant MeSH terms:
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Amputation, Traumatic
Wounds and Injuries