Human Upper Extremity Allotransplantation: F/U Protocol

Study Overview
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Brief Summary
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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.

Official Title
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Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol

Conditions
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Amputation, Traumatic, Wounds and Injury, Hand Injuries

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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 | Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | Annually for 5 years (±90 days) | 
| Use CT Angiography | To delineate the outline and architecture of vasculature and blood flow patterns in the limb. | 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. | Annually for 5 years (±90 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand Transplant, composite tissue allograft (CTA), Vascularized Composite Allotransplantation (VCA), Amputation, Upper Limb, Immunosuppression