Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT03400345

Conditions

Amputation, Traumatic

Wounds and Injury

Hand Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Amputation, Traumatic

Wounds and Injury

Hand Injuries

Study ID

NCT03400345

Start date

Jul 25, 2017

Status verified date

May, 2026

Completion date

Jul 30, 2036

Anticipated

Primary completion date

Jul 30, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.
  • Completes the protocol informed consent form.
  • Consents to sample collection and storage (biopsies).
  • USA citizen or equivalent.
  • Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Exclusion Criteria:

  • Candidate has not received an upper extremity allotransplant.
  • Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

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)) ]
  • QOL assessed for Hand Function by Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [ Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days)) ]
  • QOL assessed by Lawton Instrumental Activities of Daily Living (ADL/IADL) Questionnaire [ Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Michigan Hand Outcomes Questionnaire [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Short Musculoskeletal Function Assessment (SMFA) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Brief Pain Inventory (Short Form) (BPISF) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Quality of life assessed for Psychological Measures by Brief Symptom Inventory [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Psychological Measures by Satisfaction with Life Scale (SWLS) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Psychological Measures assessed by Affect Balance Scale (ABS) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
  • Psychological Measures assessed by NEO Five-Factor Inventory (NEO-FFI) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]

Central Contacts and Locations

Central contacts

Jane Littleton, C.R.N.P

410-955-6875jlittl38@jhmi.edu

TBD TBD

443-287-7848

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Carisa M Cooney, MPH, CCRP

443-287-4629ccooney3@jhmi.edu

TBD TBD

443-287-7848

Principal Investigator:

Jaimie Shores, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Hand Transplant
  • composite tissue allograft (CTA)
  • Vascularized Composite Allotransplantation (VCA)
  • Amputation
  • Upper Limb
  • Immunosuppression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-11.