The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices.
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to the face and upper extremity areas of individuals who have suffered injury to those areas. Upper extremity constitutes the part of the body including arm, forearm and hand. This procedure is called combined craniomaxillofacial and upper extremity allotransplantation or "combined face and upper extremity transplant". This study will also collect data on how patients do during and after having a combined face and upper extremity transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits. Participants are invited to take part in this research study who have suffered severe injury to the face and upper extremity and previous surgeries to repair the injury have not restored function, appearance, and sensation. Participants must have attempted a trial of prosthetics (artificial upper extremity), if at all possible.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
NYU Langone Health
New York, New York, United States
RECRUITINGChange in function of the transplanted facial segment
This will be measured using electromyogram (EMG)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using nerve conduction studies (NCS)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using computerized tomography angiogram (CTA)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using magnetic resonance imaging (MRI)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using vision exams
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using pathology samples to check for rejection
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using electromyogram (EMG)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in function of the upper extremity transplant
This will be measured using nerve conduction studies (NCS)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using computerized tomography angiogram (CTA)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using magnetic resonance imaging (MRI)
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in appearance of the transplanted facial segment
This will be measured using photography
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in appearance of the upper extremity transplant
This will be measured using photography
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5