Hand Transplantation: Functional and Quality of Life Outcomes

NCT02331355 | Withdrawn

• 1 other identifier: HUM00078607
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Immunosuppression requirements

  Transplant through end of study (5 years)

• Allograft rejection

  Transplant through end of study (5 years)

• Allograft Function

  Transplant through end of study (5 years)

• Quality of life

  Transplant through end of study (5 years)

Other Outcomes (1)

• Cost and utilization information

  Transplant through end of study (5 years)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had traumatic hand transplantation below the elbow.

You may qualify if:

• Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study.

You may not qualify if:

• Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 6, 2015
• Study Start: April 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

US (1)