Transplanting both arms in patients with bilateral amputations
Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
This study tests if transplanting both arms can help people with double arm amputations regain function and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (LYON cedex 03) |
| Trial ID | NCT02508831 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the outcomes of double upper limb allografts in patients with bilateral amputations of the upper limbs. It focuses on providing functional benefits by comparing the results of arm and forearm transplants within the same patient. The study aims to address the significant limitations in autonomy faced by these patients and improve their quality of life through surgical intervention. The approach involves careful selection of candidates and monitoring of post-transplant outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with bilateral upper limb amputations, particularly those with at least one amputation level above the elbow.
Not a fit: Patients with tumor-related amputations or those who have not experienced a failure of current prosthetic options may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the independence and quality of life for patients with bilateral upper limb amputations.
How similar studies have performed: While there have been studies on upper limb transplants, this specific approach of double upper limb allograft is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women * Bilateral amputation of upper limb regardless of the nature of the injury (crush, tearing, cutting, infectious such as purpura fulminans...) except for tumor diseases * Lesion level: * The non-transplant patients-free immunosuppressive therapy: bilateral amputation of upper limb with at least one lesion level above the elbow. Higher amputation level is fixed to the upper 1/4 of the arm to allow for a recovery of active flexion of the elbow against gravity. * For organ transplant patients (other than hand or upper extremity: ex liver, kidney) and already under bi - or tri-therapy immunosuppressive : bilateral amputation of upper limb with at least one lesion level above the elbow. The top level of amputation may be above the upper 1/4 of the arm especially if body image disorders dominate the complaint of the patient. * Period since amputation of at least 6 months * Failure of all currently available (including the prosthetic) support modalities * Psychological maturity: absence of serious disorder of the personality or chronic disorders of mood reported by psychiatrists of the team using tests for the assessment of personality, committed and voluntary patients * Signature of the free and informed consent form Exclusion Criteria: * Mono-amputee patient * Patients with brachial plexus lesions * Patients with vascular disorders likely result in thrombosis * Active smoking patients * Patients in an emergency medical situation * Antecedent of malignant tumor in remission for less than 5 years * Patients with malignant tumor * Patients with a American Society of Anesthesiology (ASA) score \> 3 * Patients with glomerular filtration \< 60 ml/min * Patients with severe hypertension : Systolic Blood Pressure (SBP) \> 140 mmHg and Diastolic Blood Pressure (DBP) \> 90 mmHg
Where this trial is running
LYON cedex 03
- Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation — LYON cedex 03, France (Recruiting)
Study contacts
- Study coordinator: Lionel BADET, MD, PhD
- Email: lionel.badet@chu-lyon.fr
- Phone: +33 4 721 105 87
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.