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Hand Transplantation: Functional and Quality of Life Outcomes

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ClinicalTrials.gov Identifier: NCT02331355
Recruitment Status : Withdrawn (unable to find appropriate candidates)
First Posted : January 6, 2015
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Kagan Ozer, University of Michigan

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.


Condition or disease
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

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: VCA (Hand Transplantation): Functional and Quality of Life Outcomes
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2020
Actual Study Completion Date : November 2020



Primary Outcome Measures :
  1. Allograft survival [ Time Frame: Transplant through end of study (5 years) ]
    Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5


Secondary Outcome Measures :
  1. Immunosuppression requirements [ Time Frame: Transplant through end of study (5 years) ]
    immunosuppression will be documented throughout study

  2. Allograft rejection [ Time Frame: Transplant through end of study (5 years) ]
    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

  3. Allograft Function [ Time Frame: Transplant through end of study (5 years) ]
    Outcomes questionnaires will be completed by patient at post-transplant 3, 6, 12 months, and every year thereafter up to 5 years

  4. Quality of life [ Time Frame: Transplant through end of study (5 years) ]
    SF-36 survey results will be collected before transplant and at various time points post transplant


Other Outcome Measures:
  1. Cost and utilization information [ Time Frame: Transplant through end of study (5 years) ]
    cost and utilization of service will be tracked



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had traumatic hand transplantation below the elbow.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331355


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Responsible Party: Kagan Ozer, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02331355    
Other Study ID Numbers: HUM00078607
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Keywords provided by Kagan Ozer, University of Michigan:
amputation, hand, forearm, arm, traumatic, transplantation
Additional relevant MeSH terms:
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Amputation, Traumatic
Wounds and Injuries