The primary objective of this study is to evaluate the 5-year (60-month) allograft survival rate of upper extremity vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol.
Competent to provide informed consent, as determined through structured clinical assessment by qualified study personnel, and able to demonstrate adequate psychosocial support, including caregiver or other support-person assistance as needed, to facilitate postoperative recovery, adherence to immunosuppressive therapy, and long-term study follow-up.
Willingness to undergo comprehensive psychosocial evaluation and ongoing monitoring by the multidisciplinary team.
Demonstrated motivation for transplantation and understanding of the investigational nature of upper extremity VCA, including its risks, potential benefits, alternatives, and long-term commitments.
Evidence of psychological stability and adaptive coping, with attention to prior trauma, grief, and body-image disturbances; stable treatment for conditions such as depression, anxiety, or post-traumatic stress disorder is acceptable when documented and appropriately managed.
Anatomical or surgical factors that render transplantation unsafe or technically unfeasible (e.g., prohibitive vascular disease, prior surgeries precluding adequate anastomoses) in the judgment of the surgical team.
Positive Human Immunodeficiency Virus (HIV) serology (unless future evidence and institutional policy support inclusion under tightly controlled conditions).
Active or inadequately treated serious infection, including tuberculosis, hepatitis B or C with uncontrolled viremia, or syphilis.
Active malignancy.
Single group
Upper Extremity Vascularized Composite Allotransplantation (VCA)
Procedure/SurgeryUpper Extremity VCA, performed to treat severe facial defects. This procedure will be performed by qualified surgeons in accordance with standard institutional surgical practices.
Number of participants with Allograft Survival at 60 months
Allograft survival is defined as the continued presence of the transplanted upper extremity tissue with evidence of adequate vascular perfusion assessed as clinical evaluation by the surgical team. Survival is a binary categorical variable (Success/Failure). Failure is defined as total graft loss necessitating surgical removal (explantation).
Mean Active Range of Motion
Measured in degrees for the transplanted joint (the elbow (in some occasions), the wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints).
Muscle strength assessed using Clinical Motor Grading (MRC Scale)
Medical Research Council (MRC) Scale is a standardized 0-to-5 manual muscle testing system used by clinicians to grade muscle strength and motor power. Motor strength was graded on a scale from M0 to M5, where M0 indicates no visible muscle contraction and M5 indicates normal muscle strength against full resistance
Mean Grip Strength
Quantified in kilograms (kg) using a calibrated hand dynamometer
Mean Pinch Strength
Quantified in kilograms (kg) using a calibrated pinch gauge
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Yale University
Lead sponsor
Wake Forest University Health Sciences
Collaborator
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