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Hand Transplantation: Functional and Quality of Life Outcomes

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University of Michigan

Status

Withdrawn

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT02331355
HUM00078607

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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