Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

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 Overview

• Status: Unknown
• Conditions: Hand Transplant; Hand Replant

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Donna Stacy, RN, MSN; Phone Number: 502-562-0313; Email: dstacy@cmki.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength		Up to 12 months
Pinch Strength		Up to 12 months
DASH Questionnaire	Subjects will complete the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.	Up to 12 months

Collaborators and Investigators

• Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
• Collaborators: University of Missouri-Columbia
• Investigators: Principal Investigator: Christina L Kaufman, PhD, Christine M. Kleinert Institute for Hand and Microsurgery

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 13, 2012

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: hand transplant; hand replant
• Other Study ID Numbers: 11.0616