Function Following Thumb MP Fusion and IP Fusion

NCT ID: NCT03661281

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-06-24

Brief 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simulated Thumb Arthrodesis

Subjects will have their thumb immobilized in 2 prefabricated wrist splints to simulate 2 different fusion positions tested: one splint to simulate the MCP fusion and one to represent the IP fusion. Patients will complete hand function tests in each of the splints to evaluate hand function.

Group Type: EXPERIMENTAL

Jebsen Taylor Hand function test

Intervention Type: DIAGNOSTIC_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

Intervention Type: DIAGNOSTIC_TEST

Measured in every splint position using a standard dynamometer

Grooved pegboard test

Intervention Type: DIAGNOSTIC_TEST

Time will be measured and compared between control, MP splint and IP splint

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Pinch strength

Measured in every splint position using a standard dynamometer

Intervention Type: DIAGNOSTIC_TEST

Grooved pegboard test

Time will be measured and compared between control, MP splint and IP splint

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eitan Melamed, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01281

Identifier Type: -

Identifier Source: org_study_id