Diagnostic POCUS of Patellar Tendinopathy in Female Athletes (POCUS)

May 18, 2023 updated by: Morgan Bagley, Youngstown State University

Diagnostic Point of Care Ultrasound of Patellar Tendon in Female Collegiate Athletes

Purpose: The purpose of this study is to determine the clinical effectiveness of point-of-care diagnostic ultrasound in the assessment of patellar tendon pathologies

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will receive information about the study and informed consent will be provided. Participants will voluntarily agree to be a participant in the study. Participants will sign the informed consent, and complete the POCUS demographic information sheet, if they qualify then they will have both of their patellar tendons examined through the use of the Butterfly IQ diagnostic ultrasound. Following the examination, they will complete the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Knee Injury and Osteoarthritis Outcome Patellofemoral subscale (KOOS-PF) and then complete the study.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Youngstown, Ohio, United States, 44555
        • Recruiting
        • Youngstown State University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Omar Ross, DAT
        • Principal Investigator:
          • Morgan C Bagley, PhD
        • Sub-Investigator:
          • Chad Cochran, DO
        • Sub-Investigator:
          • Matthew Campbell, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-25 yr. old female student-athletes who participate in jump-centric activities

Exclusion Criteria:

  • anyone who does not fit the inclusion criteria (18-25 yr old female student-athletes who participate in jump-centric activities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jumping
Female jumping collegiate athletes
Diagnostic test: POCUS
Point of Care Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of patellar tendons in jumping athletes
Time Frame: 2 years
% of participants with hyperechoic or hypoechoic changes
2 years
KOOS
Time Frame: 2 years
% of participants with hyperechoic or hypoechoic changes in relation to the Knee Injury and Osteoarthritis Scores
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Youngstown State University

Investigators

  • Principal Investigator: Morgan C Bagley, PhD, Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YoungstownSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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