Human Upper Extremity Allotransplantation: F/U Protocol

May 5, 2023 updated by: Johns Hopkins University

Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University School of Medicine
        • Principal Investigator:
          • Jaimie Shores, MD
        • Contact:
        • Sub-Investigator:
          • Damon S Cooney, MD, PhD
        • Sub-Investigator:
          • Richard J Redett, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Men and women who have previously received unilateral or bilateral upper limb transplants.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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
Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
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
Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
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
Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
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
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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)
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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)
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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)
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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)
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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)
Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
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.
Time Frame: Annually for 5 years post-enrollment (±90 days)
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
Time Frame: Annually for 5 years (±90 days)
For immune monitoring, to screen for donor specific antibodies.
Annually for 5 years (±90 days)
Perform Skin Biopsy
Time Frame: Annually for 5 years (±90 days)
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
Time Frame: Annually for 5 years (±90 days)
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
Time Frame: Annually for 5 years (±90 days)
To help assess progression of nerve regeneration distal to the site of transplanted nerve coaptation.
Annually for 5 years (±90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Jaimie Shores, M.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2031

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00068053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pooled patient data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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