Function Following Thumb MP Fusion and IP Fusion

Osteoarthritis Clinical Trial

Official title:

Function Following Thumb MP Fusion and IP Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661281
• Other study ID #: 17-01281
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 24, 2019

Study information

• Verified date: February 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to determine function following simulated thumb metacarpophalangeal (MP) and thumb interphalangeal (IP) joint fusion. The investigators want to determine the functional limitation created by MP and IP joint fusion. 20-30 volunteers will be fitted for custom molded orthoplast splints immobilizing either the MP or IP joint. The volunteers will then be taken through multiple tests including lateral pinch strength, tip pinch, grip strength, grooved pegboard test time, and Jebson Taylor test. Each patient will be tested without a splint, with their MP joint immobilized and with their IP joint immobilized. The results of this study can be used for patient education before surgery in order to help them make informed decisions as well as manage expectations. It can also serve as a decision aid in pinch restoration in the context of ulnar nerve palsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 24, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient is a healthy volunteer

• Patient is willing and able to review and sign a study informed consent form

Exclusion Criteria:

• Any subject who does not want to voluntarily participate.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Diagnostic Test:
• Jebsen Taylor Hand function test
consists of seven test items, which are felt to represent various hand activities. These test items include: writing a short sentence; turning over 365 inch cards; picking up small objects and placing in a container; stacking checkers; simulated eating; moving empty large cans; and moving weighted large cans.
• Pinch strength
Measured in every splint position using a standard dynamometer
• Grooved pegboard test
Time will be measured and compared between control, MP splint and IP splint

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jebsen Taylor hand function test	This consists of seven test items, which are felt to represent various hand activities. Each activity will be timed.	1 Month