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Recruiting NCT03400345

Human Upper Extremity Allotransplantation: F/U Protocol

— Observational Amputation, Traumatic Wounds and Injury Hand Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Amputation, Traumatic, Wounds and Injury, Hand Injuries. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol

Overview

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.

Primary outcome measures

  • 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))]
  • 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))]
  • 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))]
  • Michigan Hand Outcomes Questionnaire [Time frame: 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))]
  • Brief Pain Inventory (Short Form) (BPISF) [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 [Time frame: 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))]
  • Psychological Measures assessed by Affect Balance Scale (ABS) [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) [Time frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
Secondary outcome measures (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. [Time frame: 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)]
  • Perform Skin Biopsy [Time frame: Annually for 5 years (±90 days)]
  • Use CT Angiography [Time frame: Annually for 5 years (±90 days)]
  • Magnetic Resonance (MR) Neurography [Time frame: Annually for 5 years (±90 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Johns Hopkins University School of Medicine — Baltimore

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. PMID 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. PMID 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. PMID 28654973

Identifiers

NCT: NCT03400345 · NA_00068053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗