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Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases (DAMIE)

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ClinicalTrials.gov Identifier: NCT02508831
Recruitment Status : Recruiting
First Posted : July 27, 2015
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE July 21, 2015
First Posted Date  ICMJE July 27, 2015
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE July 7, 2016
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
Changes in functional recovery from baseline to 5 years after the transplant of upper limbs [ Time Frame: Before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after a double transplant of upper limbs. ]
Functional results assessed by a multidimensional evaluation:
  • A general clinical assessment
  • An analytical assessment:
    • Articular : Total Active Motion (TAM) as a percentage of Total Passive Motion (TPM)
    • Muscle: manual muscle strength testing and quantitative by Jamar dynamometers
  • A sensory and proprioceptive balance: sensitivity on mapping of WINN-PARRY, with assessment of sensitivity of protection and discriminative touch mobile and static touch, Moving Two Points Distance, Static Two Points Distance (Weber test).
  • A functional balance based on: DASH test, Carroll test, balance of 400 points, tests of independence and Hand Transplantation Score System (HTSS)
  • Impact on quality of life: measured by the Medical Outcome Study Short Form-36 (MOS SF-36)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02508831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Patients body image perception [ Time Frame: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    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)
  • Patients' self-esteem [ Time Frame: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    The Rosenberg self-esteem scale will be used to evaluate patients amputated and then grafted.
  • Brain plasticity post-transplant [ Time Frame: Before intervention, then 3, 6, 12, 18 and 24 months after the 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.
  • Acute rejection rate in post-transplant period [ Time Frame: To be measured at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    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.
  • Chronic rejection rate in post-transplant period [ Time Frame: Throughout the five years of follow-up ]
    To be approached by various exams:
    • MRI
    • CT scan of segments transplanted
    • Micro-Doppler looking for intimal hypertrophy
    • An endovascular echography of vessels above the fold of the elbow
    • Capillaroscopy
    • Arteriography will be carried out at 5 years to better appreciate achieving vascular grafts
    • Histological study of the skin and deep tissues.
  • Walking analysis in posturography [ Time Frame: To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
  • Patients body image perception [ Time Frame: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    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)
  • Patients' self-esteem [ Time Frame: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    The Rosenberg self-esteem scale will be used to evaluate patients amputated and then grafted.
  • Brain plasticity post-transplant [ Time Frame: It will be measured before the intervention, and then to 1, 3, 6 months and 1 year after the 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.
  • Acute rejection rate in post-transplant period [ Time Frame: To be measured at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    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.
  • Chronic rejection rate in post-transplant period [ Time Frame: Throughout the five years of follow-up ]
    To be approached by various exams:
    • MRI
    • CT scan of segments transplanted
    • Micro-Doppler looking for intimal hypertrophy
    • An endovascular echography of vessels above the fold of the elbow
    • Capillaroscopy
    • Arteriography will be carried out at 5 years to better appreciate achieving vascular grafts
    • Histological study of the skin and deep tissues.
  • Walking analysis in posturography [ Time Frame: To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
Official Title  ICMJE Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bilateral Amputation of Upper Limb
Intervention  ICMJE Procedure: Double upper limb allograft
Patients with bilateral amputation of upper limb will receive a double upper limb allograft
Study Arms  ICMJE Experimental: Bilateral amputation of upper limb
Patients with bilateral amputation of upper limb will receive a double upper limb allograft
Intervention: Procedure: Double upper limb allograft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2015)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lionel BADET, MD, PhD +33 4 721 105 87 lionel.badet@chu-lyon.fr
Contact: Marine DUPUIS, CRA +33 4 788 612 25 marine.dupuis01@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02508831
Other Study ID Numbers  ICMJE 69HCL14_0199
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP