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Hand Transplantation: Functional and Quality of Life Outcomes

NCT ID: NCT02331355

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-11-30

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.

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

Keywords

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amputation, hand, forearm, arm, traumatic, transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kagan Ozer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00078607

Identifier Type: -

Identifier Source: org_study_id