Human Upper Extremity Allotransplantation: F/U Protocol

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03400345
Status
Recruiting

Conditions

  • Amputation, Traumatic
  • Hand Injuries
  • Wounds and Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.

Key Dates

Start date
Jul 25, 2017
Status verified
May 2026
Primary completion
Jul 30, 2036
Completion
Jul 30, 2036

Study Design

Enrollment
60 participants (estimated)

Primary Outcome Measure

Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test [ Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days)) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21287
Carisa M Cooney, MPH, CCRP
443-287-4629
TBD TBD
443-287-7848
Damon S Cooney, MD, PhD (SUB_INVESTIGATOR)
Jaimie Shores, MD (PRINCIPAL_INVESTIGATOR)
Richard J Redett, MD (SUB_INVESTIGATOR)

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