Function Following Thumb MP Fusion and IP Fusion

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03661281

Collaborator

(none)

Enrollment

Location

Arm

16.7

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Diagnostic Test: Jebsen Taylor Hand function test Diagnostic Test: Pinch strength Diagnostic Test: Grooved pegboard test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Function Following Thumb MP Fusion and IP Fusion

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

Jun 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Diagnostic Test: Pinch strength Measured in every splint position using a standard dynamometer Diagnostic Test: Grooved pegboard test Time will be measured and compared between control, MP splint and IP splint

Arm

Intervention/Treatment

Experimental: 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.

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.

Diagnostic Test: Pinch strength

Measured in every splint position using a standard dynamometer

Diagnostic Test: Grooved pegboard test

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

Outcome Measures

Primary Outcome Measures

Jebsen Taylor hand function test [1 Month]
This consists of seven test items, which are felt to represent various hand activities. Each activity will be timed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Eitan Melamed, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03661281

Other Study ID Numbers:

17-01281

First Posted:

Sep 7, 2018

Last Update Posted:

Feb 7, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Feb 7, 2020