NCT06199583

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 17, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 17, 2023

Last Update Submit

December 29, 2023

Conditions

Patellar Tendinopathy

Keywords

Patellar tendinopathyshear-wave elastographyultrasound

Outcome Measures

Primary Outcomes (2)

  • Shear-wave elastography

    Ultrasound shear-wave elastography

    Through study completion, an average of 3 months

  • Ultrasound

    Tendon thickness, hypoechoic region, power doppler

    Through study completion, an average of 3 months

Study Arms (2)

Patellar tendinopathy

Contains athletes with patellar tendinopathy

Diagnostic Test: Shear-wave elastography

Non-patellar tendinopathy

Contains athletes without patellar tendinopathy

Diagnostic Test: Shear-wave elastography

Interventions

Shear-wave elastographyDIAGNOSTIC_TEST

Ultrasound shear-wave elastography

Non-patellar tendinopathyPatellar tendinopathy

Eligibility Criteria

Age17 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

female athletes between the ages of 17-35 playing professional basketball or volleyball.

You may qualify if:

  • being a female athlete between the ages of 17-35 playing professional basketball or volleyball and agreeing to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Faculty of Medicine Sports Medicine Department

Istanbul, 34450, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sports Medicine Specialist

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 10, 2024

Study Start

August 17, 2020

Primary Completion

November 1, 2020

Study Completion

December 31, 2020

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)