NCT01618682

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

7 years

First QC Date

June 11, 2012

Last Update Submit

January 23, 2018

Conditions

Hand TransplantHand Replant

Keywords

hand transplanthand replant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Grip Strength

    Up to 12 months

  • Pinch Strength

    Up to 12 months

  • DASH Questionnaire

    Up to 12 months

Study Arms (2)

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 Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • younger than 18 years or older than 70 years
  • not undergone a replant or transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christine M. Kleinert Insitute of Hand and Microsurgery

Louisville, Kentucky, 40202, United States

RECRUITING

Study Officials

  • Christina L Kaufman, PhD

    Christine M. Kleinert Institute for Hand and Microsurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina L Kaufman, PhD

CONTACT

502-562-0390ckaufman@cmki.org

Donna Stacy, RN, MSN

CONTACT

502-562-0313dstacy@cmki.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(1)