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

NCT ID: NCT04144946

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2021-10-31

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)

Conditions

Tendon Injuries; Tendinopathy; Patella; Tendinitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy control group (CTRL)

Sports active individuals with no history of patellar tendinopathy.

No interventions assigned to this group

Early tendinopathy group (ET)

Sports active individuals with clinical signs of early tendinopathy and debut of symptoms within 90 days.

No interventions assigned to this group

Chronic tendinopathy group (CT)

Sports active individuals with clinical signs of tendinopathy and duration of symptoms \>90 days.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nikolaj Mølkjær Malmgaard-Clausen

Medical Doctor, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Kjær, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Sports Medicine, Copenhagen

Locations

Institute of Sports Medicine Copenhagen

Copenhagen, NV, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nikolaj Malmgaard-Clausen, MD

Role: CONTACT

nikolaj.moelkjaer.malmgaard-clausen@regionh.dk

+4538635069

Facility Contacts

Nikolaj M. Malmgaard-Clausen, MD

Role: primary

nmal0015@regionh.dk

+4538635069

Other Identifiers

BBH-148

Identifier Type: -

Identifier Source: org_study_id