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 range

18 Years – 100 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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))

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 range

18 Years – 100 Years

Sex

ALL

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))