Tendon Injuries7TKneeNCT04144946
Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
An observational study of Tendon Injuries and Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
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)… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendon Injuries, Tendinopathy, Patella; Tendinitis
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Oct 2019to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sports active individuals
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine Copenhagen
Copenhagen, NV, 2400
Nikolaj M. Malmgaard-Clausen, MD, +4538635069, nmal0015@regionh.dk
About this study
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.
Read the 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
- Medical subject headings
- Tendon Injuries, Tendinopathy, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group (CTRL) | Sports active individuals with no history of patellar tendinopathy. | |
| Early tendinopathy group (ET) | Sports active individuals with clinical signs of early tendinopathy and debut of symptoms within 90 days. | |
| Chronic tendinopathy group (CT) | Sports active individuals with clinical signs of tendinopathy and duration of symptoms >90 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans
Magnetic Resonance Imaging of the knee, used to measure cross sectional area (cm^2)
Measured: 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.
Measured: 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).
Measured: 0 months, observational cross sectional study.
Secondary outcomes (5)
International Physical Activity Questionnaire (IPAQ)
IPAQ categorical scores (High, moderate or low activity level) will be reported, to characterise participants activity level
Measured: 0 months, observational cros sectional study.
Body Mass Index
BMI
Measured: 0 months, observational cross sectional study.
Questionnaires - weekly activity level (time consumption)
hours/week spend on leisure time activities loading the legs.
Measured: 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.
Measured: 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.
Measured: 0 months, observational cross sectional study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start18 Oct 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj Mølkjær Malmgaard-Clausen, Bispebjerg Hospital
- Investigators
- Michael Kjær, Professor, Principal investigator, Institute of Sports Medicine, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144946
- Sponsor's protocol ID
- BBH-148
- Acronym
- 7TKnee
- Status last verified
- Mar 2021
- First submitted
- 18 Oct 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
- ClinicalTrials.gov ID
- NCT04144946
- Acronym / sponsor ID
- 7TKnee / BBH-148
- Conditions
- Tendon Injuries, Tendinopathy, Patella; Tendinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group (CTRL) | – | –Sports active individuals with no history of patellar tendinopathy. |
| Early tendinopathy group (ET) | – | –Sports active individuals with clinical signs of early tendinopathy and debut of symptoms within 90 days. |
| Chronic tendinopathy group (CT) | – | –Sports active individuals with clinical signs of tendinopathy and duration of symptoms >90 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sports active individuals
Key inclusion criteria (23 listed)
- Common for all groups
- Sports active individuals.
- Age [18-45] years old.
- BMI [18.5-30]
- ET - group
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans
Time frame: 0 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 scans
Time frame: 0 months, observational cross sectional study.
Magnetic Resonance Imaging of the knee used to calculate decay times (ms) in the tendon tissue.
Patellar tendon biopsies
Time frame: 0 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).
5 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: 0 months, observational cros sectional study.
Body Mass Index
Time frame: 0 months, observational cross sectional study.
Questionnaires - weekly activity level (time consumption)
Time frame: 0 months, observational cross sectional study.
Questionnaires - Numerical Rating Scale (NRS) - Pain
Time frame: 0 months, observational cross sectional study.
VISA-P
Time frame: 0 months, observational cross sectional study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kjær, Professor principal investigator
Institute of Sports Medicine, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendon Injuries and Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolaj Malmgaard-Clausen, MD (+4538635069, nikolaj.moelkjaer.malmgaard-clausen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross sectional area (CSA) on Magnetic Resonance Imaging knee scans (time frame: 0 months, observational cross sectional study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.