Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)NCT04313621
Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status
An observational study of Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson), run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)
- How many people
- 1,218 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Apr 2021to 22 Apr 2021
- How long will I take part?
- 1 Day
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sample size will be of convenience with no pre-determined cut-off for smallest or largest sample of interest, rather, the final sample of respondents will be based on however many have been designated the diagnostic codes and responds to the survey.
Who may be able to join
- All patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (Severs, Sinding-Larsen Johansson, Osgood Schlatter) in the years 1977-2020 in Denmark will be eligible to participate.
Who cannot join
- Diseased participants will be censored
Trial locations and contacts
1 site in 1 country.
About this study
Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. We are therefore conducting a national cross-sectional study based on data from the Danish National Patient Registry. In this protocol we describe, as detailed as possible, the planned methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical and mental health
SF-12 (Short-form 12 item) health survey
Measured: Baseline
Secondary outcomes (6)
Sleep: problems and duration
Measured: Baseline
Self-reported level of satisfaction with participation in physical activity and sports
Tegner activity scale (0-10, 10 being no physical activity) and individual specific specific questions
Measured: Baseline
Knee pain
Evaluated on at 0-100 numerical pain rating scale pertaining (0 being no pain) to the knee or other body parts, and worst pain last week or the last month
Measured: Baseline
KOOS subscales
Knee injury and Osteoarthritis Outcome Score (KOOS) and its 5 subscale each scoring 0-100, with 100 being the no problems.
Measured: Baseline
Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel
Measured: Baseline
PAS-2
Physical activtiy scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start8 Apr 2021
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,218 participants (actual)
- Target duration
- 1 Day
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
- NCT04313621
- Sponsor's protocol ID
- 123456789
- Status last verified
- Feb 2023
- First submitted
- 17 Mar 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full dataset, excluding all personal identifiers, will be posted alongside the pre-print when the results have been disseminated.
Publications
Krommes K, Bjerre A, Thorborg K, Nielsen MF, Holmich P. Long-Term Knee Health in Adults with a History of Adolescent Osgood-Schlatter: A National Cohort Study of Patients in Secondary Care in Denmark 1977-2020. Sports Med. 2025 Jul;55(7):1769-1781. doi: 10.1007/s40279-025-02214-5. Epub 2025 May 29.
PubMed 40439870
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status
- ClinicalTrials.gov ID
- NCT04313621
- Acronym / sponsor ID
- 123456789
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,218 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 18 Mar 2020 (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.
Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. We are therefore conducting a national cross-sectional study based on data from the Danish National Patient Registry. In this protocol we describe, as detailed as possible, the planned methods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sample size will be of convenience with no pre-determined cut-off for smallest or largest sample of interest, rather, the final sample of respondents will be based on however many have been designated the diagnostic codes and responds to the survey.
Key inclusion criteria (1 listed)
- All patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (Severs, Sinding-Larsen Johansson, Osgood Schlatter) in the years 1977-2020 in Denmark will be eligible to participate.
Key exclusion criteria (1 listed)
- Diseased participants will be censored
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
Physical and mental health
Time frame: Baseline
SF-12 (Short-form 12 item) health survey
6 secondary outcomes
Sleep: problems and duration
Time frame: Baseline
Self-reported level of satisfaction with participation in physical activity and sports
Time frame: Baseline
Knee pain
Time frame: Baseline
KOOS subscales
Time frame: Baseline
Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel
Time frame: Baseline
PAS-2
Time frame: Baseline
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 1 Mar 2023.
- Derived from this study: PubMed 40439870Krommes K, Bjerre A, Thorborg K, Nielsen MF, Holmich P. Long-Term Knee Health in Adults with a History of Adolescent Osgood-Schlatter: A National Cohort Study of Patients in Secondary Care in Denmark 1977-2020. Sports Med. 2025 Jul;55(7):1769-1781. doi: 10.1007/s40279-025-02214-5. Epub 2025 May 29.
- Individual participant dataSharing planned: Yes. The full dataset, excluding all personal identifiers, will be posted alongside the pre-print when the results have been disseminated.
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 Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson), 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 1 inclusion and 1 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 1 Mar 2023. 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?
Physical and mental health (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313621, which also lists 1 linked publication.
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 1 Mar 2023.