Clinical trial NCT02331355: Hand Transplantation: Functional and Quality of Life Outcomes
Official title: VCA (Hand Transplantation): Functional and Quality of Life Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: 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
Keywords: amputation, hand, forearm, arm, traumatic, transplantation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had traumatic hand transplantation below the elbow.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Allograft survival
timeFrame: Transplant through end of study (5 years)
Secondary outcomes:
measure: Immunosuppression requirements
timeFrame: Transplant through end of study (5 years)
measure: Allograft rejection
timeFrame: Transplant through end of study (5 years)
measure: Allograft Function
timeFrame: Transplant through end of study (5 years)
measure: Quality of life
timeFrame: Transplant through end of study (5 years)
Other outcomes:
measure: Cost and utilization information
timeFrame: Transplant through end of study (5 years)
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: