Hand Transplantation: Functional and Quality of Life Outcomes

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

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.

Study Overview

• Status: Withdrawn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

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had traumatic hand transplantation below the elbow.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost and utilization information	cost and utilization of service will be tracked	Transplant through end of study (5 years)

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: amputation, hand, forearm, arm, traumatic, transplantation
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: HUM00078607