Diagnostic POCUS of Patellar Tendinopathy in Female Athletes

Sponsor

Youngstown State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05880277

Collaborator

(none)

Enrollment

Location

Arm

26.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Disorder	Diagnostic Test: POCUS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

female collegiate jumping athletesfemale collegiate jumping athletes

Masking:

None (Open Label)

Masking Description:

Team physician will exam images but will be blinded from participant. Will only see participant number.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 17, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

May 15, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Jumping

Female jumping collegiate athletes

Diagnostic Test: POCUS

Point of Care Ultrasound

Outcome Measures

Primary Outcome Measures

Changes of patellar tendons in jumping athletes [2 years]
% of participants with hyperechoic or hypoechoic changes
KOOS [2 years]
% of participants with hyperechoic or hypoechoic changes in relation to the Knee Injury and Osteoarthritis Scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Youngstown State University	Youngstown	Ohio	United States	44555

Sponsors and Collaborators

Youngstown State University

Investigators

Principal Investigator: Morgan C Bagley, PhD, Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morgan Bagley, Assistant Professor, Youngstown State University

ClinicalTrials.gov Identifier:

NCT05880277

Other Study ID Numbers:

YoungstownSU

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Yes

Keywords provided by Morgan Bagley, Assistant Professor, Youngstown State University

POCUS

Study Results

No Results Posted as of May 30, 2023