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
| Condition(s) | Bilateral Traumatic Amputation of Upper Limbs |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 tum |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | Hospices Civils de Lyon |
| Locations | Berck, France; Bruges, France; Clamart, France; Lille, France; Lyon, France; Lyon, France (+5 more sites) |
| Start date | 2018-10-16 |
| NCT ID | NCT02797457 |
| Official listing | https://clinicaltrials.gov/study/NCT02797457 |