Evaluation of hand and forearm transplants for double amputees
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
This study tests if hand and forearm transplants can help double amputees live more independently and improve their quality of life compared to using prosthetics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 11 sites (Berck and 10 other locations) |
| Trial ID | NCT02797457 on ClinicalTrials.gov |
What this trial studies
This study evaluates the medical economics of bilateral allografts of hands and forearms in patients who have undergone double traumatic amputations. It aims to assess the feasibility and functional outcomes of hand transplants compared to prosthetic solutions, focusing on the autonomy and quality of life of the patients. The study includes adult participants aged 18 to 60 years who have been amputated for at least three months and meet specific health criteria. The research is conducted at multiple rehabilitation centers in France.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 who have experienced double amputations of the forearms and meet the specific health criteria for transplantation.
Not a fit: Patients who have only one arm amputated or those with a history of malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and autonomy for patients with bilateral upper limb amputations.
How similar studies have performed: Previous studies have shown promising functional results from hand transplants, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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%
Where this trial is running
Berck and 10 other locations
- Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale — Berck, France (Recruiting)
- Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies — Bruges, France (Recruiting)
- Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy — Clamart, France (Recruiting)
- Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir — Lille, France (Recruiting)
- Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues — Lyon, France (Recruiting)
- Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon — Lyon, France (Recruiting)
- Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari — Miribel, France (Recruiting)
- Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation — Nancy, France (Recruiting)
- Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape — Ploemeur, France (Recruiting)
- Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon — Saint-Genis-Laval, France (Recruiting)
- Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné — Valenton, France (Recruiting)
Study contacts
- Study coordinator: Lionel BADET, M
- Email: lionel.badet@chu-lyon.fr
- Phone: 4 72 11 91 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.