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The case of patients with amputation of forearm on one side and arm on the other is particularly interesting to study because in this situation of handicap greater than a double amputation in forearm. We should bring a functional benefit to the patient with the transplant of forearm and this situation allows to have the best possible control to compare the result of the transplant of arm to that of forearm because it is realized at the same patient.
Amputation of both arms deprives patients of an elbow what establishes a major factor of limitation of autonomy and makes patients totally dependent for the realization of the essential gestures of the current life requiring the prehension (dress, dressing, food, hygiene of the elimination). The various equipments are not always adaptable and usable. Psychologically, an amputation in arm is unanimously considered as an infringement very badly accepted of the physical integrity and establishes a major handicap factor of family, professional and social exclusion.
The results of this study should allow a better appreciation of indications and modalities of care of biamputed patients with at least one lesion level above the elbow.
This clinical research will determine the potential place of a reconstructive surgery as allograft in biamputed patients on the basis of functional results and assessment of disorders of the body schema perception.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral amputation of upper limb | Experimental | Patients with bilateral amputation of upper limb will receive a double upper limb allograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double upper limb allograft | Procedure | Patients with bilateral amputation of upper limb will receive a double upper limb allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in functional recovery from baseline to 5 years after the transplant of upper limbs | Functional results assessed by a multidimensional evaluation:
| Before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after a double transplant of upper limbs. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients body image perception | An auto-questionnaire based on 3 questions answered by level type Likert (not at all agree, disagree, neutral, agree, quite agree) • Questionnaire Fragebogen zum KorperBild 20 (FKB-20) | To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lionel BADET, MD, PhD | Contact | +33 4 721 105 87 | lionel.badet@chu-lyon.fr | |
| Marine DUPUIS, CRA | Contact | +33 4 788 612 25 | marine.dupuis01@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation | Recruiting | Lyon | 69437 | France |
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| Patients' self-esteem |
The Rosenberg self-esteem scale will be used to evaluate patients amputated and then grafted. |
| To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant |
| Brain plasticity post-transplant | The degree of reorganization of the primary motor cortex will be measured by the assessment of re-innervation and the integration of the graft to the body schema by cerebral functional MRI with psychological tests. | Before intervention, then 3, 6, 12, 18 and 24 months after the transplant. |
| Acute rejection rate in post-transplant period | To be appreciated by inflammatory signs (erythema) at the clinical examination. The diagnosis of acute rejection will be confirmed on the basis of histological results. | To be measured at 6 months, 1, 2, 3, 4 and 5 years after transplant |
| Chronic rejection rate in post-transplant period | To be approached by various exams:
| Throughout the five years of follow-up |
| Walking analysis in posturography | The walking analysis is a non-invasive examination which consist in recording the movements by a roptoelectronic device. This system captures the three-dimensional position of retro-reflective markers placed on the body. Once analyzed, this information allows getting data quantified on movements. | To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant |