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

October 1, 2020 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • LYON cedex 03, France, 69437
        • Recruiting
        • Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral amputation of upper limb
Patients with bilateral amputation of upper limb will receive a double upper limb allograft
Procedure: Double upper limb allograft
Patients with bilateral amputation of upper limb will receive a double upper limb allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after a double transplant of upper limbs.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
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.
To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
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.
Before intervention, then 3, 6, 12, 18 and 24 months after the transplant.
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.
To be measured at 6 months, 1, 2, 3, 4 and 5 years after transplant
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.
Throughout the five years of follow-up
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.
To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2016

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL14_0199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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