Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

  • STATUS
    Recruiting
  • End date
    Oct 16, 2026
  • participants needed
    40
  • sponsor
    Hospices Civils de Lyon
Updated on 15 June 2021
Investigator
Lionel BADET, MD-PHD
Primary Contact
Service de R ducation et appareillage - Institut Robert Merle d'Aubign (9.7 mi away) Contact
+11 other location

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.

Details
Condition Bilateral Traumatic Amputation of Upper Limbs
Treatment Bilateral allograft of the hands and forearms., Prosthetic forehands
Clinical Study IdentifierNCT02797457
SponsorHospices Civils de Lyon
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

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/1.73m
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%
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