Human Upper Extremity Allotransplantation: F/U Protocol

NCT03400345 | Recruiting DMC

• 1 other identifier: NA_00068053
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• 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.

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

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

  Annually for 5 years (±90 days)

• Perform Skin Biopsy

  Annually for 5 years (±90 days)

• Use CT Angiography

  Annually for 5 years (±90 days)

• Magnetic Resonance (MR) Neurography

  Annually for 5 years (±90 days)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 28361279 BACKGROUND

• 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.

  PMID: 25401735 BACKGROUND

• 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.

  PMID: 28654973 BACKGROUND

Related Links

• Human Upper Extremity Allotransplantation

MeSH Terms

Conditions

Amputation, Traumatic; Wounds and Injuries; Hand Injuries

Study Officials

• Jaimie Shores, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Littleton, C.R.N.P

CONTACT

410-955-6875; jlittl38@jhmi.edu

TBD TBD

CONTACT

443-287-7848

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: January 17, 2018
• Study Start: July 25, 2017
• Primary Completion (Estimated): July 30, 2036
• Study Completion (Estimated): July 30, 2036
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)