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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04144946
Other study ID # BBH-148
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2019
Est. completion date October 2021

Study information

Verified date March 2021
Source Bispebjerg Hospital
Contact Nikolaj Malmgaard-Clausen, MD
Phone +4538635069
Email nikolaj.moelkjaer.malmgaard-clausen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Tendon tissue plays an essential role in transmitting contractile forces to bone to produce movement and is therefore uniquely designed to withstand considerable loads (up to ~8 times body weight) during human locomotion. Yet, repetitive use often results in overuse injuries such as tendinopathies, which is a common clinical condition characterized by pain during activity, localized tenderness upon palpation, swelling of the tendon and impaired performance. Tendinopathy is a sizeable problem in both elite and recreational athletes. In fact, the incidence of tendon injuries has been estimated to be as high as 30-50% of all sports injuries, and 50% of elite endurance runners, and 6% of sedentary people will at some point experience a tendon injury. Moreover, the symptoms and reduction in performance may be quite protracted and last for years. To date the ability to detect the early onset of the disease, and thus to prevent it from becoming chronic and debilitating, remains an enigma and the investigators wish to bridge this gap in knowledge by studying patellar tendon tissue samples coupled with magnetic resonance imaging (3T and 7T)


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 - Pregnancy - Lactation ET - group - Previous injuries in the patellar tendon on the ipsilateral side. - Started systematized treatment. CTRL - group - Previous injuries in the patellar tendon on the ipsilateral side.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Institute of Sports Medicine Copenhagen Copenhagen NV

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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 International Physical Activity Questionnaire (IPAQ) IPAQ categorical scores (High, moderate or low activity level) will be reported, to characterise participants activity level 0 months, observational cros sectional study.
Secondary Body Mass Index BMI 0 months, observational cross sectional study.
Secondary Questionnaires - weekly activity level (time consumption) hours/week spend on leisure time activities loading the legs. 0 months, observational cross sectional study.
Secondary Questionnaires - Numerical Rating Scale (NRS) - Pain range 0-10, 10 being the highest possible pain level and 0 being no pain. 0 months, observational cross sectional study.
Secondary VISA-P Standardised score of functional capability, in patient with patellar tendinopathy. Total score will be reported; scale (0-100). 100=full functional capacity 0=poor functional capacity. 0 months, observational cross sectional study.
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