Traumatic Amputation of Arm Clinical Trial
Official title:
Vascularized Composite Allotransplantation of the Hand and Upper Extremity for the Restoration of Form and Function in Hand Amputees
The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary research effort with the goal of restoring form and function to unilateral or bilateral upper extremity amputees by vascularized composite allotransplantation of the hand/upper extremity (hand transplantation). Hand transplantation includes transferring upper extremities/hands from deceased human donors to patients with single or bilateral hand or arm amputation. The purpose of the trial is to study functional, psychological, and immunological outcomes of human upper extremity allotransplantation.
Hand transplantation is the surgical attachment of a hand and sometimes an arm from an organ
donor to a person who has previously suffered an amputation. It is similar to other organ
transplants, such as a heart, liver, or kidney, in that the tissue comes from a deceased
donor and therefore requires lifelong medications to prevent rejection. Hand transplantation
also requires extensive hand rehabilitation to regain function of the transplanted limb.
The primary focus of the study is to perform hand transplantation using a steroid-sparing
immunosuppression regimen, to closely follow outcomes for at least 2 years after the
transplant, and to utilize new methods for immune system and functional recovery. The number
and severity of side effects and the treatment provided will be analyzed in relation to the
standard immunosuppressive drugs used. Functional and clinical outcomes will be correlated
with data on quality of life.
After consultation with the study team and signing of the study consent forms, patients will
undergo a thorough screening phase, including imaging, laboratory tests, age-appropriate
screening, psychosocial evaluations, physical and occupational therapy (OT) screening, and
tissue typing. Patients will then be selected by a formal patient selection committee
meeting, based on results of screening procedures.
If found to be a good candidate for hand transplantation, the patient will be listed with the
United Network for Organ Sharing (UNOS) to wait for a compatible donor. Organ donors from the
surrounding region will be screened for compatibility in regards to blood type and tissue
type, as well as hand size, skin color, tone, and hair patterns. Once a matching donor is
located, the hand transplant team and participant will be notified.
After surgery the patient will stay in the intensive care unit for 1-3 days and then move to
a regular hospital room where they will stay for 1-2 weeks. Physical therapy will begin
within 2-3 days after surgery, and transplant staff will give daily information on the
anti-rejection medications. After discharge from the hospital, the patient will stay locally
for 3-6 months to monitor for signs of rejection and for extensive hand rehabilitation.
Housing will be provided during this period by the hospital. Functional, psychological and
immunological outcomes will then be closely followed for the life of the allograft.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01546675 -
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
|
N/A | |
| Completed |
NCT01551420 -
Home Study of an Advanced Upper Limb Prosthesis
|
N/A |