Bilateral Amputation of Upper LimbDAMIENCT02508831
Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
A study testing Double upper limb allograft in people with Bilateral Amputation of Upper Limb, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bilateral Amputation of Upper Limb
- What is being tested?
- Double upper limb allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2016to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation
Lyon, 69437
Lionel BADET, MD, PhD, +33 4 721 105 87, lionel.badet@chu-lyon.fr
Marine DUPUIS, CRA, +33 4 788 612 25, marine.dupuis01@chu-lyon.fr
About this study
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.
Read more
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.
- Conditions
- Bilateral Amputation of Upper Limb
- Being tested
- Double upper limb allograft
- Keywords
- Bilateral amputation, upper limb, allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double upper limb allograftProcedure or surgery
Patients with bilateral amputation of upper limb will receive a double upper limb allograft
| Study group | Role | What they receive |
|---|---|---|
| Bilateral amputation of upper limb | Experimental | Patients with bilateral amputation of upper limb will receive a double upper limb allograft Receives: Procedure: Double upper limb allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional recovery from baseline to 5 years after the 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)
Measured: Before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after a double transplant of upper limbs.
Secondary outcomes (6)
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)
Measured: To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
Patients' self-esteem
The Rosenberg self-esteem scale will be used to evaluate patients amputated and then grafted.
Measured: 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.
Measured: 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.
Measured: 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:
- 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.
Measured: 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.
Measured: To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start7 Jul 2016
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Amputation of Upper LimbStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508831
- Sponsor's protocol ID
- 69HCL14_0199
- Acronym
- DAMIE
- Status last verified
- Oct 2020
- First submitted
- 21 Jul 2015
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
- ClinicalTrials.gov ID
- NCT02508831
- Acronym / sponsor ID
- DAMIE / 69HCL14_0199
- Conditions
- Bilateral Amputation of Upper Limb
- Keywords
- Bilateral amputation, upper limb, allograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral amputation of upper limb | Experimental | Procedure: Double upper limb allograftPatients with bilateral amputation of upper limb will receive a double upper limb allograft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double upper limb allograftPatients with bilateral amputation of upper limb will receive a double upper limb allograft | Procedure or surgery | Bilateral amputation of upper limb |
Primary outcome
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)
6 secondary outcomes
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
Patients' self-esteem
Time frame: 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.
Acute rejection rate in post-transplant period
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double upper limb allograft in people with Bilateral Amputation of Upper Limb, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel BADET, MD, PhD (+33 4 721 105 87, lionel.badet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.