Hand Transplantation: Functional and Quality of Life Outcomes

Study Overview
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Brief Summary
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There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. The Transplant Center would like to track the patient experience from pre-operative care through surgery and post-operative care. Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; Surgical information ; Post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.

Detailed Description
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Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. The technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields. Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments. Specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.

Official Title
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VCA (Hand Transplantation): Functional and Quality of Life Outcomes

Conditions
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Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow, Amputation; Traumatic, Hand, Amputation; Traumatic, Hand, Both, Amputation; Traumatic, Arm: Forearm, at Elbow Level, Amputation; Traumatic, Arm, Upper

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study. Exclusion Criteria: Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allograft survival | Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5 | Transplant through end of study (5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunosuppression requirements | immunosuppression will be documented throughout study | Transplant through end of study (5 years) | 
| Allograft rejection | Skin and muscle biopsies will be performed days 14, then monthly in year 1, then yearly years 2-5. Donor specific antibody will also be measured at these timepoints | Transplant through end of study (5 years) | 
| Allograft Function | Outcomes questionnaires will be completed by patient at post-transplant 3, 6, 12 months, and every year thereafter up to 5 years | Transplant through end of study (5 years) | 
| Quality of life | SF-36 survey results will be collected before transplant and at various time points post transplant | Transplant through end of study (5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputation, hand, forearm, arm, traumatic, transplantation