An observational study in Amputation, Traumatic, Wounds and Injury and Hand Injuries, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Johns Hopkins University · Observational
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.
Men and women who have previously received unilateral or bilateral upper limb transplants.
Exclusion Criteria:
Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test
Measures Grasp, Grip and Pinch Strength, Range of motion - Active \& Passive. During rehabilitation sessions in clinic using activities resembling everyday tasks such as pouring water, opening/closing zippers and buttons, lifting blocks of different weight. Carroll test contains 33 questions and is scored from 0-3, 0- can perform no part of test, 1- performs test partially, 2-completes test, but takes abnormally long time or has great difficulty, and 3- performs tests normally.
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
The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). 1 indicating no difficulty and 5 indicating unable perform the function.
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
Questionnaire to asses Physical and instrumental activities for daily living. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). The scale will vary along a range of levels of competence- without any help, with some help, or does he need someone for the activities.
Time frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
Michigan Hand Outcomes Questionnaire
Monitor function, pain, work performance, and aesthetics of hand(s). Responses from 1-5, 1 being very good and 5 being very poor
Time frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
Short Musculoskeletal Function Assessment (SMFA)
The SMFA consists of two sections: 34 questions covering the assessment of the patients function and 12 questions covering how bothered patients are by their symptoms. Each question is scored 1 for no problems/no difficulty/not bothered (depending on the question) to 5 for unable to do a task/symptoms all the time/being greatly bothered.
Time frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
Brief Pain Inventory (Short Form) (BPISF)
BPISF assesses the severity of pain and its impact on functioning. It is scored from 0 to 10, 0 indicating no pain, does not interfere to 10 indicating pain as bad as you can imagine, completely interferes.
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
Brief Symptom Inventory questionnaire evaluates psychological distress and psychiatric disorders. It consists of 53-item self-report inventory in which participants rate the extent to which they have been bothered. 5-point rating scale, 0 indicating not at all bothered to 4 extremely bothered.
Time frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
Psychological Measures by Satisfaction with Life Scale (SWLS)
SWLS is a measure of life satisfaction. Uses scale to rate from 1-7, Where 1 indicates Strongly disagree to 7 indicating strongly agree.
Time frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
Psychological Measures assessed by Affect Balance Scale (ABS)
ABS is a 10-item questionnaire that assess positive and negative affect as indicators of life satisfaction and/or well-being. Score range from 0-4. 0 indicating the feeling never affected to 4, where the feeling is affected always.
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)
NEO-FFI is used to examine personality traits. Questions consists of 60 items. Items are scored from Strongly disagree to Strongly agreed
Time frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
The efficacy of various immunosuppression regimens via ImmuKnow Assay/Cylex including immunomodulatory protocols (aka - Pittsburgh Protocol, Starzl Protocol), for maintenance of unilateral and bilateral upper extremity allotransplants.
For immune monitoring, to test cell mediated immunity. Value of ≤ 225 ng/mL indicates Low immune cell response, 226-524 ng/mL- Moderate Immune response, ≥525 ng/mL- High Immune cell Response.
Time frame: Annually for 5 years post-enrollment (±90 days)
Immunology- antibody testing by obtaining donor specific antibodies (DSA) by Luminex
For immune monitoring, to screen for donor specific antibodies.
Time frame: Annually for 5 years (±90 days)
Perform Skin Biopsy
To diagnose and assess acute rejection, Graft versus Host Disease and for surveillance of chronic rejection
Time frame: Annually for 5 years (±90 days)
Use CT Angiography
To delineate the outline and architecture of vasculature and blood flow patterns in the limb.
Time frame: Annually for 5 years (±90 days)
Magnetic Resonance (MR) Neurography
To help assess progression of nerve regeneration distal to the site of transplanted nerve coaptation.
Time frame: Annually for 5 years (±90 days)
Plan to share: No — Pooled patient data will be shared.
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