Status:
RECRUITING
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Bilateral Traumatic Amputation of Upper Limbs
Eligibility:
All Genders
18-60 years
Phase:
NA
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 eve...
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
- 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%
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02797457
Start Date
October 16 2018
End Date
October 16 2031
Last Update
May 8 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
Berck, France, 62600
2
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
Bruges, France, 33520
3
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
Clamart, France, 92140
4
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
Lille, France, 59260