Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants
This study is currently recruiting participants.
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Christine M. Kleinert Institute for Hand and Microsurgery
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: January 30, 2013
Last verified: January 2013
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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:
| 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
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: Rebecca E Jones, BA 502-562-0307 rjones@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: | January 30, 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 May 21, 2013