Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
7TKnee
1 other identifier
observational
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
1 active site
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
First Submitted
Initial submission to the registry
October 18, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedMarch 25, 2021
March 1, 2021
2 years
October 18, 2019
March 23, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans
Magnetic Resonance Imaging of the knee, used to measure cross sectional area (cm\^2)
0 months, observational cross sectional study.
Decay times from Magnetic Resonance Imaging knee scans
Magnetic Resonance Imaging of the knee used to calculate decay times (ms) in the tendon tissue.
0 months, observational cross sectional study.
Patellar tendon biopsies
Tendon biopsies obtained with bard magnum instrument approximately 10 mg. Used for quantitative mRNA measures expressed as relative values to the expression of a housekeeping gene with stable expression (AU).
0 months, observational cross sectional study.
Secondary Outcomes (5)
International Physical Activity Questionnaire (IPAQ)
0 months, observational cros sectional study.
Body Mass Index
0 months, observational cross sectional study.
Questionnaires - weekly activity level (time consumption)
0 months, observational cross sectional study.
Questionnaires - Numerical Rating Scale (NRS) - Pain
0 months, observational cross sectional study.
VISA-P
0 months, observational cross sectional study.
Study Arms (3)
Healthy control group (CTRL)
Sports active individuals with no history of patellar tendinopathy.
Early tendinopathy group (ET)
Sports active individuals with clinical signs of early tendinopathy and debut of symptoms within 90 days.
Chronic tendinopathy group (CT)
Sports active individuals with clinical signs of tendinopathy and duration of symptoms \>90 days.
Eligibility Criteria
Sports active individuals
You may qualify if:
- Common for all groups
- Sports active individuals.
- Age \[18-45\] years old.
- BMI \[18.5-30\]
- ET - group
- 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.
- +7 more criteria
You may not qualify if:
- 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
- Pregnancy
- Lactation
- ET - group
- Previous injuries in the patellar tendon on the ipsilateral side.
- Started systematized treatment.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine Copenhagen
Copenhagen, NV, 2400, Denmark
Biospecimen
Bilateral tendon biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Kjær, Professor
Institute of Sports Medicine, Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, PhD student
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 30, 2019
Study Start
October 18, 2019
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
March 25, 2021
Record last verified: 2021-03