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Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

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ClinicalTrials.gov Identifier: NCT01618682
Recruitment Status : Recruiting
First Posted : June 13, 2012
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery

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
Hand Transplant Hand Replant

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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Grip Strength [ Time Frame: Up to 12 months ]
  2. Pinch Strength [ Time Frame: Up to 12 months ]
  3. DASH Questionnaire [ Time Frame: Up to 12 months ]
    Subjects will complete the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618682


Contacts
Contact: Christina L Kaufman, PhD 502-562-0390 ckaufman@cmki.org
Contact: Donna Stacy, RN, MSN 502-562-0313 dstacy@cmki.org

Locations
United States, Kentucky
Christine M. Kleinert Insitute of Hand and Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Contact: Millicent L Horn, BS    502-562-0307    mhorn@cmki.org   
Principal Investigator: Christina L Kaufman, PhD         
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

Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01618682     History of Changes
Other Study ID Numbers: 11.0616
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
hand transplant
hand replant