RecruitingNot Applicable

Human Upper Extremity Allotransplantation: F/U Protocol

United States60 participantsStarted 2017-07-25

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test

Timeframe: 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

Timeframe: 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

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

Michigan Hand Outcomes Questionnaire

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

Short Musculoskeletal Function Assessment (SMFA)

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

Brief Pain Inventory (Short Form) (BPISF)

Timeframe: 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

Trial details

NCT IDNCT03400345

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2036-07-30

Contact for this trial

Jane Littleton, C.R.N.P

410-955-6875 jlittl38@jhmi.edu

View on ClinicalTrials.gov More Amputation, Traumatic trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test

Timeframe: 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

Timeframe: 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

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

Michigan Hand Outcomes Questionnaire

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

Short Musculoskeletal Function Assessment (SMFA)

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

Brief Pain Inventory (Short Form) (BPISF)

Timeframe: 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