Osgood-Schlatter DiseaseNCT03589001
24 Month Follow-up of Patients With Osgood Schlatter (OSD)
An observational study of Osgood-Schlatter Disease and Apophysitis, run by Aalborg University at 1 site in Denmark.
Trial summary
Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Osgood-Schlatter Disease, Apophysitis
- What is being tested?
- Activity modification
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jul 2018to 28 Feb 2019
- 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescents aged 10-14 years old diagnosed with Osgood Schlatter
Who may be able to join
- 10-14 years of age
- Pain at tibial tuberosity during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
- Pain during palpation of tibial tuberosity
- Knee pain for 6 weeks or more
Who cannot join
- Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
- Previous surgery
- Pain from the hip or back that interferes with activities of daily living.
- Habitual patella luxations
- Clinical suspicion of meniscal lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Investigation of Osgood Schlatter With 24 Month Follow-up
Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case.
Read the detailed description
This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood schlatter. Participants are followed for two years.
- Conditions
- Osgood-Schlatter Disease, Apophysitis
- Being tested
- Activity modification
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity modificationOther
Activity modification, exercises and gradual return to sport
| Study group | Role | What they receive |
|---|---|---|
| OSD | 51 adolescents with Osgood Schlatter who participated in an activity modification intervention. Receives: Other: Activity modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current knee pain
Participants self-report if they still have knee pain
Measured: 24 months
Secondary outcomes (9)
Pain intensity
Worst pain in the previous week measured on a visual analogue scale (VAS) from 'no pain' to 'worst imaginable pain'
Measured: 24 months
Pain frequency
Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never)
Measured: 24 months
Duration of being pain-free
Those who no longer have knee pain will be asked how long since their knee pain resoved
Measured: 24 months
Medical attention
Participants will be asked to report if they sought medical attention outside of the intervention
Measured: 24 months
Use of pain killers
Participants will be asked if they use painkillers to manage their knee pain (y/n). If yes, they will be asked how often.
Measured: 24months
knee injury and osteoarthritis outcomes score (KOOS) sport and activity subscale
knee injury and osteoarthritis outcomes score (KOOS) subscale sport and activity. Minimum 0 points, maximum 100points, with 100 points being the best possible score.
Measured: 24 months
Sports participation
Participants will report if they participate in sport. If yes how often and how much/week. They will also report if they have reduced sports participation due to knee pain.
Measured: 24 months
Health Related quality of life
Health related quality of life assessed by EQ 5D 3L Y (EuroQol, 5 dimensions, 3 levels for youth). Minimum 0, maximum 1, with higher values indicating higher quality of life.
Measured: 24 months
Sleep
Participants will be asked if they find it hard to sleep because of their knee pain (not at all, some nights, most nights).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start10 Jul 2018
- Primary completion1 Dec 2018
- Study completion28 Feb 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinead Holden, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589001
- Sponsor's protocol ID
- N-20140100-5
- Status last verified
- Jul 2019
- First submitted
- 3 Jul 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request, inline with Data Protection procedures
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation of Osgood Schlatter With 24 Month Follow-up
- ClinicalTrials.gov ID
- NCT03589001
- Acronym / sponsor ID
- N-20140100-5
- Conditions
- Osgood-Schlatter Disease, Apophysitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 17 Jul 2018 (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 common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case.
Detailed description
This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood schlatter. Participants are followed for two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSD | – | Other: Activity modification51 adolescents with Osgood Schlatter who participated in an activity modification intervention. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescents aged 10-14 years old diagnosed with Osgood Schlatter
Key inclusion criteria (4 listed)
- 10-14 years of age
- Pain at tibial tuberosity during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
- Pain during palpation of tibial tuberosity
- Knee pain for 6 weeks or more
Key exclusion criteria (5 listed)
- Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
- Previous surgery
- Pain from the hip or back that interferes with activities of daily living.
- Habitual patella luxations
- Clinical suspicion of meniscal lesion
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 |
|---|---|---|
| Activity modificationActivity modification, exercises and gradual return to sport | Other | OSD |
Primary outcome
Current knee pain
Time frame: 24 months
Participants self-report if they still have knee pain
9 secondary outcomes
Pain intensity
Time frame: 24 months
Pain frequency
Time frame: 24 months
Duration of being pain-free
Time frame: 24 months
Medical attention
Time frame: 24 months
Use of pain killers
Time frame: 24months
knee injury and osteoarthritis outcomes score (KOOS) sport and activity subscale
Time frame: 24 months
Sports participation
Time frame: 24 months
Health Related quality of life
Time frame: 24 months
Sleep
Time frame: 24 months
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 2 Jul 2019.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon reasonable request, inline with Data Protection procedures
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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 and Apophysitis, run by Aalborg University 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 2 Jul 2019. 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?
Current knee pain (time frame: 24 months). 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 2 Jul 2019.