Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI (NCT04144946) | Clinical Trial Compass
UnknownNot Applicable
Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
Denmark45 participantsStarted 2019-10-18
Plain-language summary
This project will investigate patellar tendon tissue (transmission electron microscopy of structure and protein analyses) coupled with magnetic resonance imaging (1.5T and 7T) from persons with i) chronic patellar tendinopathy (CT), ii) the earliest possible signs and symptoms of patellar tendinopathy (ET), and iii) symptom free controls (CTRL)(matched for age and physical activity/sports participation).
The investigators hypothesize that 7T MRI will be able to detect more subtle changes in early tendinopathy as compared to 3T MRI, thereby taking advantage of the increased spatial resolution that can be obtained in MRI with higher field strength. Further the investigator hypothesise that alterations in the tissue will be more pronounced in the CT group compared to ET and healthy controls.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Common for all groups
* Sports active individuals.
* Age \[18-45\] years old.
* BMI \[18.5-30\]
ET - group
* Symptom onset within 90 days at inclusion
* Clinical signs of patellar tendinopathy.
* Activity related pain in the patellar tendon.
* Palpation pain in the proximal part of the patellar tendon.
* At least one of the following three changes on the ultrasound scanning:
* Thickening of the AP diameter on the symptomatic side.
* Increased Power Doppler signal on the symptomatic side.
* Hypoechogenic area corresponding to the symptomatic area of the tendon.
CT - group,
* Symptom onset \>90 days ago
* Clinical signs of patellar tendinopathy.
* Activity related pain in the patellar tendon.
* Palpation pain in the proximal part of the patellar tendon.
* At least one of the following three changes on the ultrasound scanning:
* Thickening of the AP diameter on the symptomatic side.
* Increased Power Doppler signal on the symptomatic side.
* Hypoechogenic area corresponding to the symptomatic area of the tendon.
CTRL - group - Similar activity level as the two patient groups.
Exclusion Criteria:
Common for all groups
* Previous surgery in the knee on the ipsilateral side.
* Previous corticosteroid injection in the patellar tendon on the ipsilateral side.
* Smoking
* Known arthritis
* Known diabetes
* Known hypercholesterolemia
* Previous injections in the ipsilateral tendon.
* MRI contraindications
* Ferromagnetic objects
* Pregna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans