An observational study in Tendon Injuries, Tendinopathy and Patella; Tendinitis, sponsored by Bispebjerg Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by Bispebjerg Hospital · Observational
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.
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)
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's planned enrollment of 45 is below the median of 67 across 52 observational studies indexed under Tendinopathy.
Browse Tendinopathy studies →Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sports active individuals
Common for all groups
ET - group
At least one of the following three changes on the ultrasound scanning:
CT - group,
At least one of the following three changes on the ultrasound scanning:
CTRL - group - Similar activity level as the two patient groups.
Exclusion Criteria:
Common for all groups
MRI contraindications
ET - group
CTRL - group
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.
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans
Magnetic Resonance Imaging of the knee, used to measure cross sectional area (cm\^2)
Time frame: 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.
Time frame: 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).
Time frame: 0 months, observational cross sectional study.
International Physical Activity Questionnaire (IPAQ)
IPAQ categorical scores (High, moderate or low activity level) will be reported, to characterise participants activity level
Time frame: 0 months, observational cros sectional study.
Body Mass Index
BMI
Time frame: 0 months, observational cross sectional study.
Questionnaires - weekly activity level (time consumption)
hours/week spend on leisure time activities loading the legs.
Time frame: 0 months, observational cross sectional study.
Questionnaires - Numerical Rating Scale (NRS) - Pain
range 0-10, 10 being the highest possible pain level and 0 being no pain.
Time frame: 0 months, observational cross sectional study.
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.
Time frame: 0 months, observational cross sectional study.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Bispebjerg Hospital