Patellar TendinopathyNCT06199583
Diagnostic Value of Shear-Wave Elastography for Patellar Tendinopathy
An observational study of Patellar Tendinopathy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the accuracy of shear-wave elastography (SWE) in diagnosing patellar tendinopathy in female volleyball and basketball players. In addition, we want to compare different parts of the patellar tendon and investigated the effects of different knee angles. Read more about this study
- Who is it for?
- Ages 17 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- Shear-wave elastography
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2020to 31 Dec 2020
- Phase
- Observational
- 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 17 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: female athletes between the ages of 17-35 playing professional basketball or volleyball.
Who may be able to join
- being a female athlete between the ages of 17-35 playing professional basketball or volleyball and agreeing to participate in the study
Who cannot join
- to have a history of partial or full-thickness patellar tendon tear,
- if they received an injection in or around the patellar tendon within the past 12 months,
- undergone patellar tendon graft repair for anterior cruciate ligament, had a ligament or meniscus operation within the past six months,
- have a chronic disease (such as diabetes, heart disease, or rheumatic disease),
- are actively using oral contraceptives,
- have an active infection in the knee or surrounding tissues
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Medicine Sports Medicine Department
Istanbul, 34450
About this study
Official title: Diagnostic Value of Shear-Wave Elastography for Patellar Tendinopathy in Female Volleyball and Basketball Athletes
To investigate the accuracy of shear-wave elastography (SWE) in diagnosing patellar tendinopathy in female volleyball and basketball players. In addition, we want to compare different parts of the patellar tendon and investigated the effects of different knee angles.
- Conditions
- Patellar Tendinopathy
- Being tested
- Shear-wave elastography
- Keywords
- Patellar tendinopathy, shear-wave elastography, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear-wave elastographyDiagnostic test
Ultrasound shear-wave elastography
| Study group | Role | What they receive |
|---|---|---|
| Patellar tendinopathy | Contains athletes with patellar tendinopathy Receives: Diagnostic Test: Shear-wave elastography | |
| Non-patellar tendinopathy | Contains athletes without patellar tendinopathy Receives: Diagnostic Test: Shear-wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear-wave elastography
Ultrasound shear-wave elastography
Measured: Through study completion, an average of 3 months
Ultrasound
Tendon thickness, hypoechoic region, power doppler
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start17 Aug 2020
- Primary completion1 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergen Devran, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199583
- Sponsor's protocol ID
- IstanbulU-SportsMedicine
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devran S, Gozubuyuk OB, Dincer S, Gunver MG, Bayraktar B. Diagnostic value of shear-wave elastography for patellar tendinopathy in female volleyball and basketball athletes: a cross sectional case control study. Phys Sportsmed. 2024 Oct;52(5):470-477. doi: 10.1080/00913847.2024.2308507. Epub 2024 Jan 23.
PubMed 38243396
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Shear-Wave Elastography for Patellar Tendinopathy in Female Volleyball and Basketball Athletes
- ClinicalTrials.gov ID
- NCT06199583
- Acronym / sponsor ID
- IstanbulU-SportsMedicine
- Conditions
- Patellar Tendinopathy
- Keywords
- Patellar tendinopathy, shear-wave elastography, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Jan 2024 (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.
To investigate the accuracy of shear-wave elastography (SWE) in diagnosing patellar tendinopathy in female volleyball and basketball players. In addition, we want to compare different parts of the patellar tendon and investigated the effects of different knee angles.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellar tendinopathy | – | Diagnostic Test: Shear-wave elastographyContains athletes with patellar tendinopathy |
| Non-patellar tendinopathy | – | Diagnostic Test: Shear-wave elastographyContains athletes without patellar tendinopathy |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- female athletes between the ages of 17-35 playing professional basketball or volleyball.
Key inclusion criteria (1 listed)
- being a female athlete between the ages of 17-35 playing professional basketball or volleyball and agreeing to participate in the study
Key exclusion criteria (6 listed)
- to have a history of partial or full-thickness patellar tendon tear,
- if they received an injection in or around the patellar tendon within the past 12 months,
- undergone patellar tendon graft repair for anterior cruciate ligament, had a ligament or meniscus operation within the past six months,
- have a chronic disease (such as diabetes, heart disease, or rheumatic disease),
- are actively using oral contraceptives,
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 |
|---|---|---|
| Shear-wave elastographyUltrasound shear-wave elastography | Diagnostic test | Non-patellar tendinopathy, Patellar tendinopathy |
Primary outcome
Shear-wave elastography
Time frame: Through study completion, an average of 3 months
Ultrasound shear-wave elastography
Ultrasound
Time frame: Through study completion, an average of 3 months
Tendon thickness, hypoechoic region, power doppler
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 38243396Devran S, Gozubuyuk OB, Dincer S, Gunver MG, Bayraktar B. Diagnostic value of shear-wave elastography for patellar tendinopathy in female volleyball and basketball athletes: a cross sectional case control study. Phys Sportsmed. 2024 Oct;52(5):470-477. doi: 10.1080/00913847.2024.2308507. Epub 2024 Jan 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Tendinopathy, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 10 Jan 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear-wave elastography (time frame: Through study completion, an average of 3 months). 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?
On the ClinicalTrials.gov record for NCT06199583, which also lists 1 linked publication.
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 10 Jan 2024.