NCT04144946|UnknownDMC
Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
7TKnee
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7TKnee
Sponsor study identifier
observational
45
1 country
1
Study Start
October 18, 2019
Actual (reported)Primary Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2019
Actual (reported)October 18, 2019
Actual (reported)October 30, 2019
Actual (reported)October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
Sports active individuals with no history of patellar tendinopathy.
Sports active individuals with clinical signs of early tendinopathy and debut of symptoms within 90 days.
Sports active individuals with clinical signs of tendinopathy and duration of symptoms \>90 days.
Sports active individuals
Institute of Sports Medicine Copenhagen
Copenhagen, NV, 2400, Denmark
Bilateral tendon biopsies
Michael Kjær, Professor
Institute of Sports Medicine, Copenhagen
First Submitted
October 18, 2019
First Posted
October 30, 2019
Study Start
October 18, 2019
Actual (reported)Primary Completion
October 2021
Estimated (date passed)Protein Turnover in Healthy and Overuse-diseased Tendon
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 25, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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