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Clinical Trials/NCT02797457
NCT02797457
Recruiting
Not Applicable

Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

Hospices Civils de Lyon11 sites in 1 country40 target enrollmentOctober 16, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bilateral Traumatic Amputation of Upper Limbs
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
11
Primary Endpoint
Treatment cost
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2018
End Date
October 16, 2031
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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%

Outcomes

Primary Outcomes

Treatment cost

Time Frame: 36 months

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

Study Sites (11)

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