Amputation; Traumatic, Arm, Upper, Between Shoulder and ElbowNCT02331355
Hand Transplantation: Functional and Quality of Life Outcomes
An observational study of Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow and Amputation; Traumatic, Hand, run by University of Michigan at 1 site in United States.
Trial summary
There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow, Amputation; Traumatic, Hand, Amputation; Traumatic, Hand, Both
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had traumatic hand transplantation below the elbow.
Who may be able to join
- Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study.
Who cannot join
- Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VCA (Hand Transplantation): Functional and Quality of Life Outcomes
There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. The Transplant Center would like to track the patient experience from pre-operative care through surgery and post-operative care.
Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; Surgical information ; Post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.
Read the detailed description
Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. The technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields.
Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.
Specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.
- Conditions
- Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow, Amputation; Traumatic, Hand, Amputation; Traumatic, Hand, Both, Amputation; Traumatic, Arm: Forearm, at Elbow Level, Amputation; Traumatic, Arm, Upper
- Keywords
- amputation, hand, forearm, arm, traumatic, transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Allograft survival
Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5
Measured: Transplant through end of study (5 years)
Secondary outcomes (4)
Immunosuppression requirements
immunosuppression will be documented throughout study
Measured: Transplant through end of study (5 years)
Allograft rejection
Skin and muscle biopsies will be performed days 14, then monthly in year 1, then yearly years 2-5. Donor specific antibody will also be measured at these timepoints
Measured: Transplant through end of study (5 years)
Allograft Function
Outcomes questionnaires will be completed by patient at post-transplant 3, 6, 12 months, and every year thereafter up to 5 years
Measured: Transplant through end of study (5 years)
Quality of life
SF-36 survey results will be collected before transplant and at various time points post transplant
Measured: Transplant through end of study (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startApr 2016
- Primary completionNov 2020
- Study completionNov 2020
Why it stopped: unable to find appropriate candidates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, Arm, Upper, Between Shoulder and ElbowStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kagan Ozer, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331355
- Sponsor's protocol ID
- HUM00078607
- Status last verified
- Nov 2020
- First submitted
- 2 Jan 2015
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VCA (Hand Transplantation): Functional and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT02331355
- Acronym / sponsor ID
- HUM00078607
- Conditions
- Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow, Amputation; Traumatic, Hand, Amputation; Traumatic, Hand, Both, Amputation; Traumatic, Arm: Forearm, at Elbow Level, Amputation; Traumatic, Arm, Upper
- Keywords
- amputation, hand, forearm, arm, traumatic, transplantation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unable to find appropriate candidates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. The Transplant Center would like to track the patient experience from pre-operative care through surgery and post-operative care.
Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; Surgical information ; Post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.
Detailed description
Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. The technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields.
Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.
Specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had traumatic hand transplantation below the elbow.
Key inclusion criteria (1 listed)
- Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study.
Key exclusion criteria (1 listed)
- Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Allograft survival
Time frame: Transplant through end of study (5 years)
Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5
4 secondary outcomes
Immunosuppression requirements
Time frame: Transplant through end of study (5 years)
Allograft rejection
Time frame: Transplant through end of study (5 years)
Allograft Function
Time frame: Transplant through end of study (5 years)
Quality of life
Time frame: Transplant through end of study (5 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow and Amputation; Traumatic, Hand, run by University of Michigan 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 16 Nov 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allograft survival (time frame: Transplant through end of study (5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.