Osgood-Schlatter DiseaseNCT05789095
Rate of Torque Development in Adolescents With Osgood-Schlatter
An observational study of Osgood-Schlatter Disease, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Osgood-Schlatter is a growth-related condition involving multiple different types of tissue in the tendon-bone interface at the tibial tubercle. Osgood-Schlatter affects one in ten adolescents causing persistent pain and reduced ability to maintain physical activities. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Osgood-Schlatter Disease
- What is being tested?
- Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2023to 30 Apr 2023
- 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents aged 9-16 residing in the uptake area of Copenhagen University Hospital, Amager-Hviodvre (1.8m total residents), who is made aware of the study be either 1) being referred to the orthopedic department for Osgood-Schlatter, 2) sees adverts and local sports clubs, or 3) sees the online advert on the research unit webpage
Who may be able to join
- Patients must be 9-16 years of age
- Presence of pain for 12 weeks or more
- Pain at tibial tubercle during loading activities
- Palpable pain at the tibial tuberosity
Who cannot join
- Previous knee or hip surgery
- Other main diagnose of anterior knee pain (patellofemoral pain, Sinding-Larsen Johansson disease, Jumpers knee, etc.)
- Hip and/or back pain interfering with activities of daily living or physical activities
- Suspicion of other main diagnose such as meniscal tears and or ligamental tears
- Unable to communicate verbally or orally in Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rate of Torque Development in Adolescents With Osgood-Schlatter: A Cross-sectional Case-control Study
Osgood-Schlatter is a growth-related condition involving multiple different types of tissue in the tendon-bone interface at the tibial tubercle. Osgood-Schlatter affects one in ten adolescents causing persistent pain and reduced ability to maintain physical activities. Changes in rate of torque development is associated with decreased neuromuscular functioning and pain chronicity, thereby affecting athletic performances and general physical activities. However, changes in rate of torque development has not been investigate in patients with Osgood-Schlatter and could help characterize the condition and guide management.
The aim of the study is to investigate early and peak rate of torque development during maximal voluntary isometric knee extension and knee flexion in adolescents with Osgood-Schlatter, compared to a matched group of asymptomatic adolescents (controls), in a cross-sectional study.
The study will include 13 adolescent participants with Osgood-Schlatter and a group of 13 pain free controls matched on sex, age, and sports participation on the group level. Testing will include rate of torque measurements of knee extension and flexion for each limb with a fixated handheld dynamometer during a single test-session lasting approximately two hours. The examiner responsible for strength-testing will be blinded to case-status. Along with anthropometric data, participants will perform the anterior knee pain provocation test to assess pain-response to sustained knee loading, a countermovement jump test to assess power and jump height, and provide patient-reported measures of condition severity, pain, disability, and quality of life. Data collection will start March 2023 and is expected to finish by May 2023.
- Conditions
- Osgood-Schlatter Disease
- Being tested
- Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)
- Keywords
- Adolescents, Rate of torque development, Osgood-Schlatter, Neuromuscular, Inhibition
- Medical subject headings
- Osteochondrosis, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)Other
Participants and their parents/guardian receives information about the test procedures. Written informed consent is obtained before clinical examination and testing.
Clinical testing is performed, anthropometric values are obtained and patient reported outcome measure is filled out, before the tests are performed. Cases will receive treatment for their condition and controls a movie ticket as compensation.
| Study group | Role | What they receive |
|---|---|---|
| Case-group | 13 adolescents, 9-16 years, with Osgood-Schlatter Disease. Receives: Other: Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz) | |
| Control-group | 13 healthy adolescents, 9-16 years, without any knee pain, matched on age, sex and type of sport on the group-level. Receives: Other: Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee extension
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee extension
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Peak rate of torque development (Nm/s/kg) during maximal isometric knee extension
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Time to peak force, during maximal isometric knee extension
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee flexion
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee flexion
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Peak rate of torque development (Nm/s/kg) during maximal isometric knee flexion
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
Measured: Day 1
Secondary outcomes (1)
Pain during strength testing (NRS 10)
Numerical Pain Rating scale, 0-10 with 0 being no pain and 10 being worst imaginable.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start28 Feb 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osgood-Schlatter DiseaseStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasper Krommes, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789095
- Sponsor's protocol ID
- H-20072873
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be published either along the primary peer-reviewed journal publication if this will be available, otherwise to a public repository with a permanent Digital Object Identifier (DOI), for example, zenodo, figshare or similar.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Torque Development in Adolescents With Osgood-Schlatter: A Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT05789095
- Acronym / sponsor ID
- H-20072873
- Conditions
- Osgood-Schlatter Disease
- Keywords
- Adolescents, Rate of torque development, Osgood-Schlatter, Neuromuscular, Inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 29 Mar 2023 (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.
Osgood-Schlatter is a growth-related condition involving multiple different types of tissue in the tendon-bone interface at the tibial tubercle. Osgood-Schlatter affects one in ten adolescents causing persistent pain and reduced ability to maintain physical activities. Changes in rate of torque development is associated with decreased neuromuscular functioning and pain chronicity, thereby affecting athletic performances and general physical activities. However, changes in rate of torque development has not been investigate in patients with Osgood-Schlatter and could help characterize the condition and guide management.
The aim of the study is to investigate early and peak rate of torque development during maximal voluntary isometric knee extension and knee flexion in adolescents with Osgood-Schlatter, compared to a matched group of asymptomatic adolescents (controls), in a cross-sectional study.
The study will include 13 adolescent participants with Osgood-Schlatter and a group of 13 pain free controls matched on sex, age, and sports participation on the group level. Testing will include rate of torque measurements of knee extension and flexion for each limb with a fixated handheld dynamometer during a single test-session lasting approximately two hours. The examiner responsible for strength-testing will be blinded to case-status. Along with anthropometric data, participants will perform the anterior knee pain provocation test to assess pain-response to sustained knee loading, a countermovement jump test to assess power and jump height, and provide patient-reported measures of condition severity, pain, disability, and quality of life. Data collection will start March 2023 and is expected to finish by May 2023.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case-group | – | Other: Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)13 adolescents, 9-16 years, with Osgood-Schlatter Disease. |
| Control-group | – | Other: Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)13 healthy adolescents, 9-16 years, without any knee pain, matched on age, sex and type of sport on the group-level. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents aged 9-16 residing in the uptake area of Copenhagen University Hospital, Amager-Hviodvre (1.8m total residents), who is made aware of the study be either 1) being referred to the orthopedic department for Osgood-Schlatter, 2) sees adverts and local sports clubs, or 3) sees the online advert on the research unit webpage
Key inclusion criteria (4 listed)
- Patients must be 9-16 years of age
- Presence of pain for 12 weeks or more
- Pain at tibial tubercle during loading activities
- Palpable pain at the tibial tuberosity
Key exclusion criteria (5 listed)
- Previous knee or hip surgery
- Other main diagnose of anterior knee pain (patellofemoral pain, Sinding-Larsen Johansson disease, Jumpers knee, etc.)
- Hip and/or back pain interfering with activities of daily living or physical activities
- Suspicion of other main diagnose such as meniscal tears and or ligamental tears
- Unable to communicate verbally or orally in Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate of torque development testing of knee flexors and knee extensors using a fixated handheld dynamometer (MicroFet 2, Hoggan, Scientific L.L.C., Salt Lake City, USA), sampling rate of 100hz)Participants and their parents/guardian receives information about the test procedures. Written informed consent is obtained before clinical examination and testing. Clinical testing is performed, anthropometric values are obtained and patient reported outcome measure is filled out, before the tests are performed. Cases will receive treatment for their condition and controls a movie ticket as compensation. | Other | Case-group, Control-group |
Primary outcome
Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee extension
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee extension
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Peak rate of torque development (Nm/s/kg) during maximal isometric knee extension
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Time to peak force, during maximal isometric knee extension
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 60 degrees of knee flexion during a 5 second maximal exertion.
Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee flexion
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
Rate of torque development (Nm/s/kg) at 0-100 ms during maximal isometric knee flexion
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
Peak rate of torque development (Nm/s/kg) during maximal isometric knee flexion
Time frame: Day 1
Test performed seated on an examination bed with a belt-fixated handheld dynamometer (MicroFet 2, Hoggan Scientific, USA) at 20 degrees of knee flexion during a 5 second maximal exertion.
1 secondary outcome
Pain during strength testing (NRS 10)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. The dataset will be published either along the primary peer-reviewed journal publication if this will be available, otherwise to a public repository with a permanent Digital Object Identifier (DOI), for example, zenodo, figshare or similar.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osgood-Schlatter Disease, run by Hvidovre University 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of torque development (Nm/s/kg) at 0-200 ms during maximal isometric knee extension (time frame: Day 1). The study lists 7 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 9 Jan 2024.