BridgeMD
New treatment option for Bilateral Traumatic Amputation of Upper Limbs
Official title Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
ClinicalTrials.gov ID: NCT02797457
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
You likely can't join if
- Mono amputated patients
- Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
See the full eligibility 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
- 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
- Mono amputated patients
- Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
The study team makes the final eligibility decision.
Where it's taking place
- Berck, France
- Bruges, France
- Clamart, France
- Lille, France
- Lyon, France
- Miribel, France
- Nancy, France
- Ploemeur, France
- Saint-Genis-Laval, France
- Valenton, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berck, France; Bruges, France; Clamart, France; Lille, France; Lyon, France; Miribel, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.