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Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI

Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04144946
Acronym
7TKnee
Enrollment
45
Registered
2019-10-30
Start date
2019-10-18
Completion date
2021-10-31
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patella; Tendinitis, Tendinopathy, Tendon Injuries

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.

Detailed 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)

Interventions

None listed

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans0 months, observational cross sectional study.Magnetic Resonance Imaging of the knee, used to measure cross sectional area (cm\^2)
Decay times from Magnetic Resonance Imaging knee scans0 months, observational cross sectional study.Magnetic Resonance Imaging of the knee used to calculate decay times (ms) in the tendon tissue.
Patellar tendon biopsies0 months, observational cross sectional study.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).

Secondary

MeasureTime frameDescription
Questionnaires - Numerical Rating Scale (NRS) - Pain0 months, observational cross sectional study.range 0-10, 10 being the highest possible pain level and 0 being no pain.
International Physical Activity Questionnaire (IPAQ)0 months, observational cros sectional study.IPAQ categorical scores (High, moderate or low activity level) will be reported, to characterise participants activity level
VISA-P0 months, observational cross sectional study.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.
Body Mass Index0 months, observational cross sectional study.BMI
Questionnaires - weekly activity level (time consumption)0 months, observational cross sectional study.hours/week spend on leisure time activities loading the legs.

Countries

Denmark

Contacts

Primary ContactNikolaj Malmgaard-Clausen, MD
nikolaj.moelkjaer.malmgaard-clausen@regionh.dk+4538635069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026