Bilateral Traumatic Amputation of Upper LimbsARMEDICNCT02797457
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
A study testing Bilateral allograft of the hands and forearms. and Prosthetic forehands in people with Bilateral Traumatic Amputation of Upper Limbs, run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities. The management of these patients is nearly exclusively through the use of prostheses. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bilateral Traumatic Amputation of Upper Limbs
- What is being tested?
- Bilateral allograft of the hands and forearms. and Prosthetic forehands
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Oct 2018to 16 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Inclusion criteria common to the 2 groups of patients (allograft group and protheses group):
- Adult aged 18 to 60 years
- Double amputated of both forearms
- Transplant eligibility criteria (for allograft group)
- Minimum interval between amputation and graft of three months (no maximal delay)
- Absence of previous psychiatric history contraindicating the graft and psychological maturity, according to two psychiatrists who have evaluated the patient
Show all 11Show fewer
- No previous history of malignant tumor in remission for less than 5 years
- American Society of Anesthesiology (ASA) score ≤ 2
- New York Heart Association (NYHA) grade ≥ 1
- Creatinine clearance ≥ 60 ml/min/1.73m²
- Absence of badly controlled sever hypertension
Who cannot join
- Mono amputated patients
- Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
Berck, 62600
Frédéric CHARLATE, MD
Frédéric CHARLATE, MD
- Recruiting
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
Bruges, 33520
Rémi KLOTZ, MD
Rémi KLOTZ, MD
- Recruiting
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
Clamart, 92140
Eric LAPEYRE, MD
Eric LAPEYRE, MD
- Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
Lille, 59260
Hervé DELAHAYE, MD
Hervé DELAHAYE, MD
- Recruiting
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
Lyon, 69005
Isabelle LAROYENNE, MD
Isabelle LAROYENNE, MD
- Recruiting
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69427
Lionel BADET, MD
Lionel BADET, MD
- Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
Miribel, 01700
Renaud TAVERNIER, MD
Renaud TAVERNIER, MD
- Recruiting
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54042
Jean PAYSANT, MD
Jean PAYSANT, MD
- Recruiting
Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
Ploemeur, 56275
Pierre VERSCHOORE, MD
Pierre VERSCHOORE, MD
- Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon
Saint-Genis-Laval, 69230
Gilles RODE, MD
Gilles RODE, MD
- Recruiting
Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné
Valenton, 94460
Florence GUILLOU, MD
Florence GUILLOU, MD
About this study
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.
The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.
Read more
Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.
The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.
A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.
- Being tested
- Bilateral allograft of the hands and forearms., Prosthetic forehands
- Keywords
- Bilateral amputation of the forearms, Bilateral allograft, Prosthetic forehands, Medical economic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral allograft of the hands and forearms.Procedure or surgery
Bilateral allograft of the hands and forearms.
Prosthetic forehandsProcedure or surgery
Prosthetic forehands
| Study group | Role | What they receive |
|---|---|---|
| Allograft | Other | Bilateral allograft of the hands and forearms. Receives: Procedure: Bilateral allograft of the hands and forearms. |
| Prostheses | Other | Prosthetic forehands Receives: Procedure: Prosthetic forehands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment cost
Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start16 Oct 2018
- Primary completion16 Oct 2031 (estimated)
- Study completion16 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Traumatic Amputation of Upper LimbsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT02797457
- Sponsor's protocol ID
- 69HCL15_0084
- Acronym
- ARMEDIC
- Status last verified
- May 2024
- First submitted
- 8 Jun 2016
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
- ClinicalTrials.gov ID
- NCT02797457
- Acronym / sponsor ID
- ARMEDIC / 69HCL15_0084
- Keywords
- Bilateral amputation of the forearms, Bilateral allograft, Prosthetic forehands, Medical economic evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 16 Oct 2031 (estimated)
- Study completion
- 16 Oct 2031 (estimated)
- First posted
- 13 Jun 2016 (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 double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.
The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.
Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.
The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.
A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allograft | Other | Procedure: Bilateral allograft of the hands and forearms.Bilateral allograft of the hands and forearms. |
| Prostheses | Other | Procedure: Prosthetic forehandsProsthetic forehands |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Inclusion criteria common to the 2 groups of patients (allograft group and protheses group):
- Adult aged 18 to 60 years
- Double amputated of both forearms
- Transplant eligibility criteria (for allograft group)
- Minimum interval between amputation and graft of three months (no maximal delay)
Key exclusion criteria (2 listed)
- Mono amputated patients
- Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
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 |
|---|---|---|
| Bilateral allograft of the hands and forearms.Bilateral allograft of the hands and forearms. | Procedure or surgery | Allograft |
| Prosthetic forehandsProsthetic forehands | Procedure or surgery | Prostheses |
Primary outcome
Treatment cost
Time frame: 36 months
Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral allograft of the hands and forearms. and Prosthetic forehands in people with Bilateral Traumatic Amputation of Upper Limbs, run by Hospices Civils de Lyon at 11 sites 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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lionel BADET, M (4 72 11 91 91 ext. +33, 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?
Treatment cost (time frame: 36 months). 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 8 May 2024.