search
Back to results

Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms (ARMEDIC)

Primary Purpose

Bilateral Traumatic Amputation of Upper Limbs

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bilateral allograft of the hands and forearms.
Prosthetic forehands
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Traumatic Amputation of Upper Limbs focused on measuring Bilateral amputation of the forearms, Bilateral allograft, Prosthetic forehands, Medical economic evaluation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation HopaleRecruiting
  • Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de GassiesRecruiting
  • Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées PercyRecruiting
  • Serice de Rééducation et Réadaptation fonctionnelles - Centre l'EspoirRecruiting
  • Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des MassuesRecruiting
  • Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de LyonRecruiting
  • Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans FerrariRecruiting
  • Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de RéadaptationRecruiting
  • Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de KerpapeRecruiting
  • Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de LyonRecruiting
  • Service de Rééducation et appareillage - Institut Robert Merle d'AubignéRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Allograft

Prostheses

Arm Description

Bilateral allograft of the hands and forearms.

Prosthetic forehands

Outcomes

Primary Outcome Measures

Treatment cost
Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses

Secondary Outcome Measures

Full Information

First Posted
June 8, 2016
Last Updated
April 18, 2023
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT02797457
Brief Title
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Acronym
ARMEDIC
Official Title
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
October 16, 2026 (Anticipated)
Study Completion Date
October 16, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Traumatic Amputation of Upper Limbs
Keywords
Bilateral amputation of the forearms, Bilateral allograft, Prosthetic forehands, Medical economic evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allograft
Arm Type
Other
Arm Description
Bilateral allograft of the hands and forearms.
Arm Title
Prostheses
Arm Type
Other
Arm Description
Prosthetic forehands
Intervention Type
Procedure
Intervention Name(s)
Bilateral allograft of the hands and forearms.
Intervention Description
Bilateral allograft of the hands and forearms.
Intervention Type
Procedure
Intervention Name(s)
Prosthetic forehands
Intervention Description
Prosthetic forehands
Primary Outcome Measure Information:
Title
Treatment cost
Description
Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lionel BADET, M
Phone
4 72 11 91 91
Ext
+33
Email
lionel.badet@chu-lyon.fr
Facility Information:
Facility Name
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
City
Berck
ZIP/Postal Code
62600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric CHARLATE, MD
First Name & Middle Initial & Last Name & Degree
Frédéric CHARLATE, MD
Facility Name
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
City
Bruges
ZIP/Postal Code
33520
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémi KLOTZ, MD
First Name & Middle Initial & Last Name & Degree
Rémi KLOTZ, MD
Facility Name
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LAPEYRE, MD
First Name & Middle Initial & Last Name & Degree
Eric LAPEYRE, MD
Facility Name
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
City
Lille
ZIP/Postal Code
59260
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé DELAHAYE, MD
First Name & Middle Initial & Last Name & Degree
Hervé DELAHAYE, MD
Facility Name
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
City
Lyon
ZIP/Postal Code
69005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle LAROYENNE, MD
First Name & Middle Initial & Last Name & Degree
Isabelle LAROYENNE, MD
Facility Name
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69427
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel BADET, MD
First Name & Middle Initial & Last Name & Degree
Lionel BADET, MD
Facility Name
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
City
Miribel
ZIP/Postal Code
01700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud TAVERNIER, MD
First Name & Middle Initial & Last Name & Degree
Renaud TAVERNIER, MD
Facility Name
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
City
Nancy
ZIP/Postal Code
54042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean PAYSANT, MD
First Name & Middle Initial & Last Name & Degree
Jean PAYSANT, MD
Facility Name
Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
City
Ploemeur
ZIP/Postal Code
56275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre VERSCHOORE, MD
First Name & Middle Initial & Last Name & Degree
Pierre VERSCHOORE, MD
Facility Name
Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles RODE, MD
First Name & Middle Initial & Last Name & Degree
Gilles RODE, MD
Facility Name
Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné
City
Valenton
ZIP/Postal Code
94460
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence GUILLOU, MD
First Name & Middle Initial & Last Name & Degree
Florence GUILLOU, MD

12. IPD Sharing Statement

Learn more about this trial

Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

We'll reach out to this number within 24 hrs