Patellofemoral DisorderPOCUSNCT05880277
Diagnostic POCUS of Patellar Tendinopathy in Female Athletes
A study testing POCUS in people with Patellofemoral Disorder, run by Youngstown State University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Disorder
- What is being tested?
- POCUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-25 yr. old female student-athletes who participate in jump-centric activities
Who cannot join
- anyone who does not fit the inclusion criteria (18-25 yr old female student-athletes who participate in jump-centric activities
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Youngstown State University
Youngstown, Ohio, 44555
Morgan C Bagley, PhD, 330-941-3650, mcbagley@ysu.edu
Matthew Campbell, PhD, 330-941-2576, mjcampbell05@ysu.edu
About this study
Official title: 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
Read the 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.
- Conditions
- Patellofemoral Disorder
- Being tested
- POCUS
- Keywords
- POCUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUSDiagnostic test
Point of Care Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Jumping | Experimental | Female jumping collegiate athletes Receives: Diagnostic Test: POCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of patellar tendons in jumping athletes
% of participants with hyperechoic or hypoechoic changes
Measured: 2 years
KOOS
% of participants with hyperechoic or hypoechoic changes in relation to the Knee Injury and Osteoarthritis Scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start17 Feb 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- female collegiate jumping athletes
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morgan Bagley, Youngstown State University
- Investigators
- Morgan C Bagley, PhD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880277
- Sponsor's protocol ID
- YoungstownSU
- Acronym
- POCUS
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Point of Care Ultrasound of Patellar Tendon in Female Collegiate Athletes
- ClinicalTrials.gov ID
- NCT05880277
- Acronym / sponsor ID
- POCUS / YoungstownSU
- Conditions
- Patellofemoral Disorder
- Keywords
- POCUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- female collegiate jumping athletes
| Arm | Type | Receives |
|---|---|---|
| Jumping | Experimental | Diagnostic Test: POCUSFemale jumping collegiate athletes |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-25 yr. old female student-athletes who participate in jump-centric activities
Key exclusion criteria (1 listed)
- anyone who does not fit the inclusion criteria (18-25 yr old female student-athletes who participate in jump-centric activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUSPoint of Care Ultrasound | Diagnostic test | Jumping |
Primary outcome
Changes of patellar tendons in jumping athletes
Time frame: 2 years
% of participants with hyperechoic or hypoechoic changes
KOOS
Time frame: 2 years
% of participants with hyperechoic or hypoechoic changes in relation to the Knee Injury and Osteoarthritis Scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan C Bagley, PhD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POCUS in people with Patellofemoral Disorder, run by Youngstown State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morgan C Bagley, PhD (330-941-3650, mcbagley@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of patellar tendons in jumping athletes (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.