Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01618682
First received: June 11, 2012
Last updated: July 9, 2013
Last verified: January 2013
  Purpose

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
Hand Transplant
Hand Replant

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:

Primary Outcome Measures:
  • Ultrasound Biomicroscopy [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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:
  • Grip Strength [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Pinch Strength [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • DASH Questionnaire [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Subjects will complete the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618682

Contacts
Contact: Christina L Kaufman, PhD 502-562-0390 ckaufman@cmki.org
Contact: Brenda Blair, RN, MSN 502-562-0313 bblair@kleinertkutz.com

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: Ross D Gibson, BA    502-562-0307    rgibson@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
  More Information

No publications provided

Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01618682     History of Changes
Other Study ID Numbers: 11.0616
Study First Received: June 11, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014