If a child meets the eligibility requirements, he or she may be considered for the hand transplant study. Because there are risks associated with having a hand transplant, we want to make sure the patient and family understand and consider the risks versus the potential benefits. The study's principle investigator and research staff will discuss the risks in detail with each interested person who may qualify to enter the study. To be sure a hand transplant is the right option, each potential participant will go through the following screening process:
- psychiatric and social support evaluation, to ensure they are psychologically prepared for transplant
- meetings with the surgical and medical team members to ensure that transplant surgery is possible and safe
- meetings with physical and occupational therapists to evaluate the patient’s current function and to ensure the patient is prepared for follow-up care
- meeting with the multidisciplinary transplant team to ensure there are no potential complications for eventual immunosuppression therapy
During the evaluation the patient will undergo a number of tests. They may include:
- blood tests
- liver and kidney function tests
- tests for viruses
- coagulation studies, routine electrolytes and complete blood count
- x-rays of affected limbs to assess anatomy
- chest x-ray to see if the lungs are healthy
- an angiogram to assess the arteries
- MRI and CT scans to look closely at the structures of arms
- studies to assess existing upper arm function
Prior to the screening process, the patient will be asked to complete a consent form that will explain the research study and the risks associated with the screening. The patient will also be given the consent form for the transplantation procedure that will further explain the study, hand transplantation and its risk and benefits. After the initial screening is complete, our team will let you know if your child has been accepted into the study. Once a patient has been accepted and properly prepared, the family and medical team at Boston Children's will wait for a suitable donor to be found through an organ bank. In addition to blood type, other considerations like the age, sex, race and size of the donor will be taken into account when matching donor hands with a recipient. Adult recipients have waited as long as a few months up to a year; we expect, however, that children may wait longer because there are fewer donors.
Hand transplant requires two surgical teams, each made up of several specialists. The first team will recover the hands from the donor; the second will prepare the recipient and attach the donor hands when they are delivered. To do so, surgeons connect the donor hand’s bones to the patient's bones, then connect the blood vessels, tendons and nerves. The skin is then closed.
The surgery takes approximately 12 to 18 hours.
Prepare donor hand and recipient arm.
Bones connected with bone plates and screws
Tendons and muscles connected with sutures.
Microscope used to connect arteries, veins and nerves.
Skin flaps are sutured to close incisions.
After the hand transplant has been completed, there is still much work to be done. Proper recovery requires medication, physical therapy and other potential steps to ensure that life with the new hands is as healthy as possible.
The patient will stay in the hospital until both the hand surgery and medical transplant teams believe the patient has recovered enough to be discharged. Recovery time will vary from patient to patient and will involved an initial stay in the intensive care unit, followed by additional recovery time as an inpatient on the transplant floor.
In about two weeks' time most patients will be discharged from the hospital, but will come back to Boston Children's several times a week for follow-up care.
It's important to remember that every patient and every transplant is different. Many cases will require different recovery techniques, medications and follow-up care.
After going home from the hospital, hand transplant patients will need to return to Boston Children's for routine check-ups. At these appointments patients will have imaging tests to monitor their recovery and blood tests to see how well the immunosuppressant drugs are working. They will undergo procedures that assess sensation and movement in the hand and receive rehabilitative therapy to strengthen it. After transplant, rehabilitation visits will be scheduled three times a week for the first year (or longer if needed), and will be two to three hours long. Based upon our experience with solid organ transplants, clinic visits to monitor immunosuppression medications and the recovery process are expected to occur two times a week for approximately two months, then once a week for two months, then twice a month for two months, then once a month for six months, and finally every three months, or as needed.
As with any transplant, patients will need to take their immunosuppressant medications as long as they have their transplant.
In the event that a patient who lives far from Boston is chosen for the study, we may be able to coordinate his follow-up care through a local medical center or hospital; this would be determined on a case-to-case basis.