Diagnostic POCUS of Patellar Tendinopathy in Female Athletes | NCT05880277

Studies
Diagnostic POCUS of Patellar Tendinopathy in Female Athletes

NCT05880277

Sponsor

Youngstown State University

Status

Unknown status

Last Update Posted

May 30, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Patellofemoral Disorder

Interventions

POCUS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2023Actual

Primary Completion Date

May 15, 2024Estimated

Completion Date

May 15, 2025Estimated

First Submitted Date

May 3, 2023

First Submission Date that Met QC Criteria

May 18, 2023

First Posted Date

May 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2023

Last Update Posted Date

May 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Morgan Bagley, Assistant Professor, Youngstown State UniversityPrincipal Investigator

Lead Sponsor

Youngstown State UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jumping	Experimental	Female jumping collegiate athletes	Diagnostic Test: POCUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
POCUS	Diagnostic Test	Point of Care Ultrasound	Jumping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Morgan C Bagley, PhD	Contact	330-941-3650		mcbagley@ysu.edu
Matthew Campbell, PhD	Contact	3309412576		mjcampbell05@ysu.edu

Overall Officials

Name	Affiliation	Role
Morgan C Bagley, PhD	Faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Youngstown State University	Recruiting	Youngstown	Ohio	44555	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

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

Who Masked

Not provided