Novel Decision Aid for Carpal Tunnel Patients

NCT ID: NCT04693273

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-01-20

Brief Summary

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A questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for Carpal Tunnel Syndrome to help participants decide between two surgical options- Wide-Awake-Local-Anesthesia-no-Tourniquet (WALANT) and traditional open hand surgery. These patients will be asked to complete a pre-questionnaire knowledge test and a post-questionnaire knowledge test. the primary objective is to validate this questionnaire to be used by other orthopedic surgeons. This study will also reveal patient preference between these two surgical treatments for carpal tunnel syndrome.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Carpal Tunnel Release surgical patients

This is the group the investigators survey who are candidates for carpal tunnel release (CTR) surgery: patients should be 18 years or older, comprehend and read English, and patients who consent to do the survey.

Decision Aid for Surgical Modality Choice

Intervention Type OTHER

A novel decision aid that helps surgical patients choose between Wide-Awake carpal tunnel release and traditional tourniquet surgery. It involves an orientation-memory-concentration test to test if patients are cognitively capable of making decisions, then the decision aid table that has similarities and differences between the two modalities, and a few survey questions that help the investigators know what the patients prefer. Finally, patients finish the decision conflict test to see how confident these patients are about their preference.

Interventions

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Decision Aid for Surgical Modality Choice

A novel decision aid that helps surgical patients choose between Wide-Awake carpal tunnel release and traditional tourniquet surgery. It involves an orientation-memory-concentration test to test if patients are cognitively capable of making decisions, then the decision aid table that has similarities and differences between the two modalities, and a few survey questions that help the investigators know what the patients prefer. Finally, patients finish the decision conflict test to see how confident these patients are about their preference.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of older,
* CTS patients who are CTR candidates,
* Comprehend and understand English,
* Passed the Orientation-memory-concentration test done before the decision aid

Exclusion Criteria

* Younger than 18 years of age,
* Non-CTS patients,
* Not CTR candidates,
* Do not comprehend or read English,
* Failed the Orientation-memory-concentration test done before the decision aid
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Charles S Day

Professor & Executive Vice Chair of the Orthopaedic Service Line

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles S Day, M.D., M.B.A.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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13583

Identifier Type: -

Identifier Source: org_study_id

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