AzTrials
AzTrials

Amputation, TraumaticNCT03400345

Human Upper Extremity Allotransplantation: F/U Protocol

An observational study of Amputation, Traumatic and Wounds and Injury, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
60 participants
Where
1 siteUnited States
Study dates
25 Jul 2017to 30 Jul 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jane Littleton, C.R.N.P contact

410-955-6875

jlittl38@jhmi.edu

TBD TBD contact

443-287-7848

United States1 site, 1 recruiting

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

    Carisa M Cooney, MPH, CCRP, 443-287-4629, ccooney3@jhmi.edu

    TBD TBD, 443-287-7848

    Recruiting

Other trials in United States

About this study

Official title: 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.

Keywords
Hand Transplant, composite tissue allograft (CTA), Vascularized Composite Allotransplantation (VCA), Amputation, Upper Limb, Immunosuppression
Medical subject headings
Amputation, Traumatic, Wounds and Injuries, Hand Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))

  2. 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.

    Measured: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))

  3. 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.

    Measured: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))

  4. 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

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

  5. 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.

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

  6. 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.

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

  7. 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.

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

  8. 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.

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

  9. 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.

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

  10. 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

    Measured: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))

Secondary outcomes (5)

  1. 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.

    Measured: Annually for 5 years post-enrollment (±90 days)

  2. Immunology- antibody testing by obtaining donor specific antibodies (DSA) by Luminex

    For immune monitoring, to screen for donor specific antibodies.

    Measured: Annually for 5 years (±90 days)

  3. Perform Skin Biopsy

    To diagnose and assess acute rejection, Graft versus Host Disease and for surveillance of chronic rejection

    Measured: Annually for 5 years (±90 days)

  4. Use CT Angiography

    To delineate the outline and architecture of vasculature and blood flow patterns in the limb.

    Measured: Annually for 5 years (±90 days)

  5. Magnetic Resonance (MR) Neurography

    To help assess progression of nerve regeneration distal to the site of transplanted nerve coaptation.

    Measured: Annually for 5 years (±90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start25 Jul 2017
  3. Primary completion30 Jul 2036 (estimated)
  4. Study completion30 Jul 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03400345
Sponsor's protocol ID
NA_00068053
Status last verified
May 2026
First submitted
13 Oct 2017
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pooled patient data will be shared.

Publications

  • Shores JT, Malek V, Lee WPA, Brandacher G. Outcomes after hand and upper extremity transplantation. J Mater Sci Mater Med. 2017 May;28(5):72. doi: 10.1007/s10856-017-5880-0. Epub 2017 Mar 30.

    PubMed 28361279

  • Shores JT, Brandacher G, Lee WPA. Hand and upper extremity transplantation: an update of outcomes in the worldwide experience. Plast Reconstr Surg. 2015 Feb;135(2):351e-360e. doi: 10.1097/PRS.0000000000000892.

    PubMed 25401735

  • Adler BL, Albayda J, Shores JT, Lee WPA, Brandacher G, Bingham CO 3rd. Erosive Rheumatoid Arthritis After Bilateral Hand Transplantation. Ann Intern Med. 2017 Aug 1;167(3):216-218. doi: 10.7326/L16-0588. Epub 2017 Jun 27. No abstract available.

    PubMed 28654973

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation, Traumatic and Wounds and Injury, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jane Littleton, C.R.N.P (410-955-6875, jlittl38@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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))). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03400345, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in