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NCT Number: NCT02797457

Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale, Berck, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Bilateral allograft of the hands and forearms.

Procedure

Bilateral allograft of the hands and forearms.

Prosthetic forehands

Procedure

Prosthetic forehands

Primary outcomes

  1. Treatment cost

    Time frame: 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lionel BADET, M

CONTACT

[email protected]

4 72 11 91 91 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ARMEDIC

Important dates

Study start
2018
Primary completion
2031
Study completion
2031
First posted
Jun 13, 2016
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.