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

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.

Study Overview

• Status: Recruiting
• Conditions: Bilateral Traumatic Amputation of Upper Limbs
• Intervention / Treatment: Procedure: Bilateral allograft of the hands and forearms.; Procedure: Prosthetic forehands

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lionel BADET, M; Phone Number: +33 4 72 11 91 91; Email: lionel.badet@chu-lyon.fr

Study Locations

• France
  • Berck, France, 62600
    • Recruiting
    • Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
    • Contact: Frédéric CHARLATE, MD
    • Principal Investigator: Frédéric CHARLATE, MD
  • Bruges, France, 33520
    • Recruiting
    • Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
    • Contact: Rémi KLOTZ, MD
    • Principal Investigator: Rémi KLOTZ, MD
  • Clamart, France, 92140
    • Recruiting
    • Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
    • Contact: Eric LAPEYRE, MD
    • Principal Investigator: Eric LAPEYRE, MD
  • Lille, France, 59260
    • Recruiting
    • Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
    • Contact: Hervé DELAHAYE, MD
    • Principal Investigator: Hervé DELAHAYE, MD
  • Lyon, France, 69005
    • Recruiting
    • Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
    • Contact: Isabelle LAROYENNE, MD
    • Principal Investigator: Isabelle LAROYENNE, MD
  • Lyon, France, 69427
    • Recruiting
    • Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
    • Contact: Lionel BADET, MD
  • Miribel, France, 01700
    • Recruiting
    • Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
    • Contact: Renaud TAVERNIER, MD
    • Principal Investigator: Renaud TAVERNIER, MD
  • Nancy, France, 54042
    • Recruiting
    • Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
    • Contact: Jean PAYSANT, MD
    • Principal Investigator: Jean PAYSANT, MD
  • Ploemeur, France, 56275
    • Recruiting
    • Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
    • Contact: Pierre VERSCHOORE, MD
    • Principal Investigator: Pierre VERSCHOORE, MD
  • Saint-Genis-Laval, France, 69230
    • Recruiting
    • Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon
    • Principal Investigator: Gilles RODE, MD
    • Contact: Gilles RODE, MD
  • Valenton, France, 94460
    • Recruiting
    • Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné
    • Contact: Florence GUILLOU, MD
    • Principal Investigator: Florence GUILLOU, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Allograft; Bilateral allograft of the hands and forearms.	Procedure: Bilateral allograft of the hands and forearms.; Bilateral allograft of the hands and forearms.
Other: Prostheses; Prosthetic forehands	Procedure: Prosthetic forehands; Prosthetic forehands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment cost	Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses	36 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Anticipated): October 16, 2026
• Study Completion (Anticipated): October 16, 2026

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Bilateral amputation of the forearms; Bilateral allograft; Prosthetic forehands; Medical economic evaluation
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 69HCL15_0084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No