Amputation; Traumatic, Arm: Forearm, at Elbow Level, Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow, Amputation; Traumatic, Hand, Amputation; Traumatic, Hand, Both
Conditions
Keywords
amputation, hand, forearm, arm, traumatic, transplantation
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Michigan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allograft survival | Transplant through end of study (5 years) | Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunosuppression requirements | Transplant through end of study (5 years) | immunosuppression will be documented throughout study |
| Allograft rejection | Transplant through end of study (5 years) | 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 |
| Allograft Function | Transplant through end of study (5 years) | Outcomes questionnaires will be completed by patient at post-transplant 3, 6, 12 months, and every year thereafter up to 5 years |
| Quality of life | Transplant through end of study (5 years) | SF-36 survey results will be collected before transplant and at various time points post transplant |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost and utilization information | Transplant through end of study (5 years) | cost and utilization of service will be tracked |
Countries
United States
Outcome results
None listed