An interventional study of A novel treatment approach and Usual care in Osgood-Schlatter Disease, Apophysitis and Osteochondrosis; Tibia, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment
The most common growth-related injury is Osgood Schlatter, which affects up to 1 in 5 physically active adolescents. It can cause long-term pain and potential discontinuation of sports and physical activity, with sequela well into adulthood. No effective conservative treatments have been documented, and clinical practice is characterized by a wealth of conflicting advice and modalities. A novel treatment approach has shown promising results in a small single-cohort study. Therefore, this study aims to compare this novel treatment with usual care in 10-16-year-old adolescents with Osgood Schlatter.
This single-center pragmatic, double-blinded, randomized, controlled superiority trial, will have a two-group parallel arm design. Participants will undergo 3 months of treatment, followed by 2 months of self-management with self-reported knee function (KOOS-child 'Sport/rec') at 5 months as the primary endpoint.
This trial comparing a novel treatment with usual care for adolescents with Osgood Schlatter could result in an evidence-based treatment ready for implementation in clinical practice, benefitting patients outcomes and clinicians.
16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.
This study's enrollment of 130 is above the median of 51 across 13 interventional studies indexed under Osteochondrosis.
Browse Osteochondrosis studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
The experimental intervention were first comprised and tested in a large cohort of 10-14-year-old adolescents with a similar condition (patellofemoral pain) and was associated with a successful outcome after 12 weeks. Afterwards, the intervention was changed slightly to target adolescents with Osgood Schlatter and then pilot-tested in a cohort of 51 participants. In this cohort, most participants needed more time to progress through exercises and sport, and the investigators have therefore piloted extending the intervention further in the clinic, with more success on these aspects. The experimental intervention will contain an active approach with self-management of load and progressive exercise therapy throughout the treatment course, delivered through 4 one-on-one visits lasting approximately 20 minutes (at months 0, 1, 2, 3) with a physiotherapist and an accompanying leaflet with written and illustrated exercise description, and advice and information.
Other: A novel treatment approach
The investigators have performed a step-wise mixed-methods sub-study to investigate current standard of care in the most common settings in Denmark (Sports Physiotherapists mainly from private primary practice, and Orthopedic Surgeons caring for these patients, invited from all public secondary care orthopedic departments in Denmark). Results were then combined with reports from patients seen in the clinic (n=34) who were questioned in detail on what modalities and advice they had previously received. The results were mostly compatible with the recent international survey of clinicians treating Osgood-Schlatter. With the findings from this process the investigators have developed a patient-aimed leaflet, which will contain vignettes and elaborations of the multimodal approaches included in the standardized usual care package, which will be implemented through four visits (at months 0, 1, 2, 3) with a physiotherapist (mirroring the plan of care of the experimental group).
Other: Usual care
A novel treatment approach, as described before.
Usual care, as described before.
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline
The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)
Patient Acceptable Symptom State change from baseline
The question pertaining to Patient Acceptable Symptom State (PASS) are designed in collaboration with patient representatives. The recall period will be one week, and the outlook period a 'few months' as in previous applications in musculoskeletal conditions with fluctuating symptoms: "If you consider your knee pain during the past week, and how it affects your ability to do activities of daily living (for example participating in school, in sports, and socially), would you consider your current symptom state acceptable for the next few months?". The proportions of yes/no in each group will be captured
Time frame: 5 months
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline
The scale contains 6 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 5 months
Frequency of Pain Flares
Weekly average of pain flares over a 4-week period leading up to the 5 months visit. Pain flares are defined as episodes of of 4 or more on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Time frame: 5 months
Pain Flare Intensity change from baseline
Pain intensity as defined as the highest rating of pain on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Time frame: 5 months
Hours of Sports Participation
The level of participation in sports will be captured through weekly monitoring. Participants will be asked if they have been participating in sports in the preceding week, and for how many hours. A 4-week average leading up to the 5 month visit will be calculated
Time frame: 5 months
Hours of Physical Activity
Minutes of Moderate to Vigorous Physical Activity (MVPA) will be captured using waterproof 3 axis 12 Hz accelerometers (SENS®, Copenhagen, Denmark) applied once to the participants thigh during the enrollment visit using an adhesive patch. A 4-week average leading up to the 5 month visit will be calculated According to WHO recommendations a daily minimum of 60 min of MVPA is needed to stay healthy for 5-17 year olds.Thus being at either under or above this cutoff during a 4-week average leading up to the 5 month visit will be assessed, in addition to a continuous comparison between the two groups of minutes of MVPA during the same time period.
Time frame: 5 months
Satisfaction with extent of sports participation change from baseline
Participants will also be asked during clinical visits if they are satisfied with the current extent of their sports participation (Yes/No questions).
Time frame: 5 months
Tendinosis signs change from baseline
Involvement of the tendon is common in patients with Osgood Schlatter. Signs of tendinosis will be assess through ultrasound scanning by evaluating either the tendon as thickened or with hyperemia through color-doppler mode.
Time frame: 5 months
Infrapatellar bursitis signs change from baseline
In Osgood-Schlatter patients, associated signs of bursitis have shown to be prognostic of a worse outcome. Signs of tendinosis will be assess through ultrasound scanning by evaluating either the infrapatellar bursa as thickened or with hyperemia through color-doppler mode.
Time frame: 5 months
Flaviis composite severity score change from baseline
In Osgood-Schlatter patients, gradings of severity have shown to be prognostic of a worse outcome. Severity will be graded according to the ad modum Flaviis 1-4 grading, or as 'normal'.
Time frame: 5 months
Anterior Knee Pain Provocation test change from baseline
Adolescents will rate their pain from performing the Anterior Knee Pain Provocation test on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Time frame: 5 months
Pain during knee extension strength test change from baseline
Adolescents will rate pain experienced during a maximal isometric knee extension strength test on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Time frame: 5 months
Pressure-pain threshold at the tibial tubercle change from baseline
To evaluate local hyperalgesia specifically at the tibial tubercle, handheld algometry will be used to detect the pressure (kPa) needed to evoke pain (going from no pain to the slightest sensation of pain) on the tibial tubercle on both knees
Time frame: 5 months
Maximal isometric knee extension strength change from baseline
To evaluate the capacity of the quadriceps femoris muscle inserting at the site of pain, handheld dynamometry will be used to measure maximal isometric force generation which will be normalized to bodyweight and lever-length (Nm/kg).
Time frame: 5 months
Countermovement jump height change from baseline
As a measure of sports-specific skill, a countermovement jump will be performed to record jump height (cm), using high-speed video analysis via a smartphone app (My Jump 2).
Time frame: 5 months
Global rating of Change
To assess patient-assessed improvement or worsening, study personnel will ask participants to rate their perceived level of change from their first visit on a 7-point likert scale ranging from 'Much worse' to 'Much better'.
Time frame: 5 months
Patient-specific function scale change from baseline
Study personnel will ask participants to rate their problems with an important activity using the Patient-Specific Functional Scale. They are asked to name a single important activity of their own choosing. Participants then rate their functional limitation with activity on a 0 to 10 scale, where 0 corresponds to being unable to perform activity and 10 is being able to perform activity at same level as before knee pain.
Time frame: 5 months
Kinesiophobia change from baseline
To capture level of kinesiophobia, that is, the fear of pain due to movement or exercise, a type of fear-avoidance behavior, the patient-reported 17-item Tampa Scala of Kinesiophobia (TSK-17) will be used.
Time frame: 5 months
Self-rated health change from baseline
Self-rated health will be collected through the 0-100 VAS for general health.
Time frame: 5 months
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Pain' Subscale change from baseline
The scale contains 8 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 5 months
Level of pain/discomfort change from baseline
Using the EQ-D5-Y scale, participants are asked on a 3-point likert scale ranging from 1 (I have no pain or discomfort), to 3 (I have extreme pain or discomfort).
Time frame: 5 months
Level of sports participation compared to before knee pain
Participants are asked if they perform either 1) at a higher level than before onset of knee pain, 2) at the same level as before onset of knee pain, or 3) at a lower level than before onset of knee pain
Time frame: 5 months
Level of physical activity compared to before knee pain
Participants are asked if they are either 1) more physically active than before onset of knee pain, 2) just as physically active as before onset of knee pain, or 3) are less physically active as before onset of knee pain
Time frame: 5 months
Time to return to sport
For the subgroup of participants not being active in sports at baseline, the week in which they return to sports participation will be recorded and compared between groups.
Time frame: 5 months
Hyperemia of the tibial tubercle change from baseline
Hyperemia of the tibial tubercle will be assess through ultrasound scanning by evaluating hyperemia ad modum Öhberg 1-4 through color-doppler mode.
Time frame: 5 months
Palpation pain of the tibial tubecle
Known pain when palpating the tibial tubecle during clinical examination change from baseline
Time frame: 5 months
Pain during Countermovement Jump Test change from baseline
Adolescents will rate pain experienced during the CMJ test on the NPRS 0-10.
Time frame: 5 months
Countermovement jump power change from baseline
As a measure of power, a countermovement jump will be performed to record jump and power-production (watts), using high-speed video analysis via a smartphone app (My Jump 2).
Time frame: 5 months
Knee extensor flexibility change from baseline
Between-group change in knee flexion angle, assessed by smartphone-inclinometry during a modified Thomas Test will be compared.
Time frame: 5 months
Satisfaction with treatment
Participants are asked if they believe the treatment recieved have been succesful or not (Yes/No question)
Time frame: 5 months
Problems with usual activities change from baseline
Using the EQ-D5-Y scale, participants are asked on a 3-point likert scale ranging from 1 (I have no problems performing my usual activities), to 3 (I am unable to perform my usual activities).
Time frame: 5 months
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Symptoms' change from baseline
The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 5 months
Harms and adverse events
Potential harms and adverse events will be assesed through open-ended questioning during clinical visits in order to assess if further examination or treatment is warranted, and to classify events according to the severity on from Grade 1-5 Using the Common Terminology Criteria for Adverse Events (CTCAE) grading: 1. Mild: Asymptomatic or minor symptoms; clinical or diagnostic observations only; no intervention needed 2. Moderate: Minimal, local, or non-invasive intervention indicated 3. Severe: Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling 4. Life-threatening consequences (i.e., immediate risk of death); urgent intervention indicated 5. Death related to adverse event
Time frame: 5 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — To increase transparency and dissemination, all statistical code and fully anonymized dataset will be shared to a open-access repository (such as YODA, Zenodo or Figshare) with a digital objective identifier once all planned publications are accepted or published as pre-print. Publication-specific datasets will potentially be posted along with published manuscripts in line with journal policies. If full anonymity cannot be achieved by removing unique data and identifies, a synthetic dataset will be created which will mimic the original dataset by preserving the statistical properties and the relationships between variables.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: All statistical code and fully anonymized dataset will be shared to a open-access repository (such as YODA, Zenodo or Figshare) with a digital objective identifier once all planned publications are accepted or published as pre-print. Anticipated to be before december 1st 2025.
Access criteria: No criteria, as data will be open access once published.
Ran from Jan 2022 to primary completion in Mar 2024, 26 months.
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