RecruitingNAINTERVENTIONAL

Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

This study explores hand and forearm transplants for individuals who have lost both upper limbs due to injury. Losing both hands can greatly affect a person's independence and daily life, making it hard to do simple tasks. While artificial hands (prostheses) are common, some people find them limiting due to lack of feeling or precise movement. Hand transplants offer a chance to regain these abilities. Researchers want to compare transplants with prostheses, looking at how they impact quality of life, independence, and overall costs. The goal is to better understand which treatment option helps patients the most, allowing them to lead fuller, more integrated lives.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

16 Oct 2018

Estimated completion

16 Oct 2031

Bilateral Traumatic Amputation of Upper Limbs

What is this study about?

Imagine losing both your hands and lower arms; it makes everyday tasks really difficult and can deeply affect how you live your life. This is a rare and challenging situation, and currently, most people in this situation use artificial hands, called prostheses. While prostheses can be very helpful, some people find them limiting because they don't offer the sense of touch, the ability to make very exact movements, or simply don't feel like a natural part of their body.

For these individuals, a double transplant of hands and forearms could be a life-changing option. Special doctors in Lyon, France, have been performing these types of transplants since 2000, and their early results have shown that patients can regain a lot of their independence for daily activities. These good results have often lasted over time, with some patients even being able to return to work, which helps them feel more connected to society.

Because this is a major procedure, patients need to take special medicines to stop their body from rejecting the new hands. While these medicines can have side effects, the study shows that the number of complicated medical issues isn't higher than with other types of transplants. This new study aims to continue tracking these patients and also to compare the transplant option directly with using prostheses. They want to look at things like costs, how it affects a person's quality of life, how independent they become, and their overall satisfaction.

Key takeaways

This study compares hand transplants with artificial limbs (prostheses) for people who have lost both forearms.
It aims to understand which treatment leads to better quality of life and independence.
The study considers the costs involved and how well people adapt to each option.
Hand transplants can help regain touch and precise movements but require lifelong anti-rejection medicine.
Researchers want to provide clearer guidance for patients facing this challenging situation.

Who may be eligible?

To be part of this study, you would generally need to be an adult between 18 and 60 years old and have lost both your lower arms due to injury.

If you're considering a transplant, there are a few more things. Your amputation must have happened at least three months ago, but there's no upper limit on how long ago it was. You’ll need to have a couple of mental health experts check to make sure you're emotionally ready for such a big procedure. You also shouldn't have had certain types of cancer in the last five years, and your general health, including your heart and kidneys, would need to be in good shape. Unfortunately, if you've only lost one arm or have certain serious health conditions, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult between 18 and 60 years old?
Have you lost both your forearms due to an injury?
If considering a transplant, was your amputation at least three months ago?
Do you generally have good heart and kidney health?
Do you have no recent history of certain types of cancer?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the specific schedule of visits, assessments, or the exact duration of follow-up for participants in this economic evaluation. However, based on the nature of the study comparing transplants and prostheses, it's highly likely that participation would involve regular check-ups, potentially including physical exams, blood tests, and assessments of your daily activities and feelings of independence, quality of life, and satisfaction. For those who have received transplants, this would include ongoing monitoring related to their anti-rejection medication. The duration of your involvement could be several months to years, as the study aims to understand long-term outcomes and comparisons between the two groups.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For those in the transplant group, a main benefit is the potential to regain a sense of touch and more precise hand movements, leading to greater independence and improved quality of life. The main risk involves the lifelong anti-rejection medication, which can have side effects like increasing the risk of infections or other medical issues. For those using prostheses, the study may help evaluate and improve their current level of care. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale
Verified postcode
Berck, France· Recruiting
Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies
Verified postcode
Bruges, France· Recruiting
Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy
Verified postcode
Clamart, France· Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir
Verified postcode
Lille, France· Recruiting
Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues
Verified postcode
Lyon, France· Recruiting
Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari
Verified postcode
Miribel, France· Recruiting
Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation
Verified postcode
Nancy, France· Recruiting
Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape
Verified postcode
Ploemeur, France· Recruiting
Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon
Verified postcode
Saint-Genis-Laval, France· Recruiting
Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné
Verified postcode
Valenton, France· Recruiting

Common questions

What is a bilateral allograft?

It's a medical procedure where a person receives a transplant of both hands and forearms from a donor.

Why is this study being done?

This study aims to compare hand and forearm transplants to artificial limbs (prostheses) to see which option offers better quality of life, independence, and is more cost-effective for patients who have lost both their lower arms.

What are prostheses?

Prostheses are artificial devices, like artificial hands or arms, that replace a missing body part.

Do I have to take special medicines if I get a transplant?

Yes, if you receive a transplant, you would need to take special medicines for the rest of your life to prevent your body from rejecting the new hands and forearms.

Can I still participate if I only lost one arm?

No, this study is specifically for people who have lost both their forearms due to injury.

How to find out more

Lionel BADET, M

lionel.badet@chu-lyon.fr 4 72 11 91 91 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.