NCT05880277

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

May 3, 2023

Last Update Submit

May 18, 2023

Conditions

Patellofemoral Disorder

Keywords

POCUS

Outcome Measures

Primary Outcomes (2)

  • Changes of patellar tendons in jumping athletes

    % of participants with hyperechoic or hypoechoic changes

    2 years

  • KOOS

    % of participants with hyperechoic or hypoechoic changes in relation to the Knee Injury and Osteoarthritis Scores

    2 years

Study Arms (1)

Jumping

EXPERIMENTAL

Female jumping collegiate athletes

Diagnostic Test: POCUS

Interventions

POCUSDIAGNOSTIC_TEST

Point of Care Ultrasound

Jumping

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

RECRUITING

Study Officials

  • Morgan C Bagley, PhD

    Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan C Bagley, PhD

CONTACT

330-941-3650mcbagley@ysu.edu

Matthew Campbell, PhD

CONTACT

3309412576mjcampbell05@ysu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Team physician will exam images but will be blinded from participant. Will only see participant number.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: female collegiate jumping athletes
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 30, 2023

Study Start

February 17, 2023

Primary Completion

May 15, 2024

Study Completion

May 15, 2025

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)