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Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery (Other)
Overall Status
Unknown status
CT.gov ID
NCT01618682
Collaborator
University of Missouri-Columbia (Other)
60
Enrollment
1
Location
84
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    Mar 1, 2019
    Anticipated Study Completion Date :
    Mar 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Ultrasound Biomicroscopy [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.

    Secondary Outcome Measures

    1. Grip Strength [Up to 12 months]

    2. Pinch Strength [Up to 12 months]

    3. DASH Questionnaire [Up to 12 months]

      Subjects will complete the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • younger than 18 years or older than 70 years

    • not undergone a replant or transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Christine M. Kleinert Insitute of Hand and Microsurgery Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • Christine M. Kleinert Institute for Hand and Microsurgery
    • University of Missouri-Columbia

    Investigators

    • Principal Investigator: Christina L Kaufman, PhD, Christine M. Kleinert Institute for Hand and Microsurgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christine M. Kleinert Institute for Hand and Microsurgery
    ClinicalTrials.gov Identifier:
    NCT01618682
    Other Study ID Numbers:
    • 11.0616
    First Posted:
    Jun 13, 2012
    Last Update Posted:
    Jan 25, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery
    hand transplant
    hand replant

    Study Results

    No Results Posted as of Jan 25, 2018