Hand TransplantNCT01618682
Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants
An observational study of Hand Transplant and Hand Replant, run by Christine M. Kleinert Institute for Hand and Microsurgery at 1 site in United States.
Trial summary
The investigators hope to gain insights into the functional organization of the human cerebral cortex in response to upper limb amputation and surgical interventions including hand replantation and hand transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hand Transplant, Hand Replant
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2019
- 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: Subjects will be patients who have undergone hand transplant or replant procedures at Kleinert Kutz and Associates or who are on the hand transplant registry.
Who may be able to join
- between 18-70 yrs old
- undergone successful allogeneic transplantation of one or both hands OR undergone successful reattachment of one or both hands OR will have experienced surgical repair of one or more severed nerves (ulnar, medial, radial, digital in the upper limb
- must speak English
Who cannot join
- younger than 18 years or older than 70 years
- not undergone a replant or transplant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Christine M. Kleinert Insitute of Hand and Microsurgery
Louisville, Kentucky, 40202
Christina L Kaufman, PhD, 502-562-0390, ckaufman@cmki.org
Millicent L Horn, BS, 502-562-0307, mhorn@cmki.org
About this study
The investigators hope to gain insights into the functional organization of the human cerebral cortex in response to upper limb amputation and surgical interventions including hand replantation and hand transplantation.
- Conditions
- Hand Transplant, Hand Replant
- Keywords
- hand transplant, hand replant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hand Transplant Patients | These will be subjects who have undergone a hand transplant. | |
| Hand Replant Patients | These will be patients who have undergone a hand replant procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Biomicroscopy
We will scan the cross section of the medial nerve at the pisiform bone level to determine the level of CTS with Ultrasound Biomicroscopy machine. This device is not approved for clinical decisions, only used for research purposes.
Measured: Up to 12 months
Secondary outcomes (3)
Grip Strength
Measured: Up to 12 months
Pinch Strength
Measured: Up to 12 months
DASH Questionnaire
Subjects will complete the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand TransplantStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Christina L Kaufman, PhD, Principal investigator, Christine M. Kleinert Institute for Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618682
- Sponsor's protocol ID
- 11.0616
- Status last verified
- Jan 2018
- First submitted
- 11 Jun 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants
- ClinicalTrials.gov ID
- NCT01618682
- Acronym / sponsor ID
- 11.0616
- Conditions
- Hand Transplant, Hand Replant
- Keywords
- hand transplant, hand replant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia
- Study start
- Mar 2012
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 13 Jun 2012 (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.
The investigators hope to gain insights into the functional organization of the human cerebral cortex in response to upper limb amputation and surgical interventions including hand replantation and hand transplantation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Transplant Patients | – | –These will be subjects who have undergone a hand transplant. |
| Hand Replant Patients | – | –These will be patients who have undergone a hand replant procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be patients who have undergone hand transplant or replant procedures at Kleinert Kutz and Associates or who are on the hand transplant registry.
Key inclusion criteria (3 listed)
- between 18-70 yrs old
- undergone successful allogeneic transplantation of one or both hands OR undergone successful reattachment of one or both hands OR will have experienced surgical repair of one or more severed nerves (ulnar, medial, radial, digital in the upper limb
- must speak English
Key exclusion criteria (2 listed)
- younger than 18 years or older than 70 years
- not undergone a replant or transplant
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
Ultrasound Biomicroscopy
Time frame: Up to 12 months
We will scan the cross section of the medial nerve at the pisiform bone level to determine the level of CTS with Ultrasound Biomicroscopy machine. This device is not approved for clinical decisions, only used for research purposes.
3 secondary outcomes
Grip Strength
Time frame: Up to 12 months
Pinch Strength
Time frame: Up to 12 months
DASH Questionnaire
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Christina L Kaufman, PhD principal investigator
Christine M. Kleinert Institute for Hand and Microsurgery
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 Hand Transplant and Hand Replant, run by Christine M. Kleinert Institute for Hand and Microsurgery 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina L Kaufman, PhD (502-562-0390, ckaufman@cmki.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Biomicroscopy (time frame: Up to 12 months). 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 25 Jan 2018.