Clinical trial NCT02508831: Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
Official title: Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bilateral Amputation of Upper Limb
Keywords: Bilateral amputation
upper limb
allograft
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Changes in functional recovery from baseline to 5 years after the transplant of upper limbs
timeFrame: Before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after a double transplant of upper limbs.
Secondary outcomes:
measure: Patients body image perception
timeFrame: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
measure: Patients' self-esteem
timeFrame: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
measure: Brain plasticity post-transplant
timeFrame: Before intervention, then 3, 6, 12, 18 and 24 months after the transplant.
measure: Acute rejection rate in post-transplant period
timeFrame: To be measured at 6 months, 1, 2, 3, 4 and 5 years after transplant
measure: Chronic rejection rate in post-transplant period
timeFrame: Throughout the five years of follow-up
measure: Walking analysis in posturography
timeFrame: To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation
Study officials:
References: