A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter

NCT05174182 | Completed

• 1 other identifier: H-21028912
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osgood-Schlatter Disease; Apophysitis; Osteochondrosis; Tibia; Physeal Injury

Keywords

Adolescents; Sport; Physical activity; Knee; Load management; Strength training; Accelerometer; Ultrasound; Tibial tubercle; Handheld dynamometry; Handheld algometry; Usual Care

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)

Secondary Outcomes (19)

• Patient Acceptable Symptom State change from baseline

  5 months

• Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline

  5 months

• Frequency of Pain Flares

  5 months

• Pain Flare Intensity change from baseline

  5 months

• Hours of Sports Participation

  5 months

Other Outcomes (14)

• Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Pain' Subscale change from baseline

  5 months

• Level of pain/discomfort change from baseline

  5 months

• Level of sports participation compared to before knee pain

  5 months

Study Arms (2)

A novel treatment approach

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

A novel treatment approach OTHER

A novel treatment approach, as described before.

A novel treatment approach

Usual care OTHER

Usual care, as described before.

Usual care

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Tenderness on palpation of the tibial tuberosity or pain during resisted isometric knee extensions
• Insidious onset of pain or swelling of the tibial tuberosity for ≥6 weeks
• Provoked by at least 2 of the following positions or activities; prolonged sitting or kneeling, squatting, running, hopping/jumping, stair walking or during multidirectional sports
• Clinical diagnosis of Osgood Schlatter
• Markedly reduced sports participation OR severely affected by pain during sports participation

You may not qualify if:

• Other primary pathology or complaints from other structures of the knee
• Other injuries, complaints or illnesses that may cause disability, or specifically restricts levels of physical activity or sports participation
• Previous surgery in the lower extremities or lumbar spine
• Congenital deformities, device implants og cysts og tumors of the knee
• Participants not willing to cease concomitant treatment
• Participants and their parents not able to understand and communicate in written and verbal Danish

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Aalborg University: collaborator
• University College Copenhagen: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2610, Denmark

Location

Related Publications (1)

• Krommes K, Thorborg K, Clausen MB, Rathleff MS, Olesen JL, Kallemose T, Holmich P. Self-management including exercise, education and activity modification compared to usual care for adolescents with Osgood-Schlatter (the SOGOOD trial): protocol of a randomized controlled superiority trial. BMC Sports Sci Med Rehabil. 2024 Apr 20;16(1):89. doi: 10.1186/s13102-024-00870-0.

  PMID: 38643184 DERIVED

MeSH Terms

Conditions

Osteochondrosis; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Kasper Krommes

  Amager Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants: Participants are blinded to the actual contents of the two interventions before being allocated, and will remain blinded to the contents of the parallel intervention. They are also blinded to the superiority framework. Care provider: Therapists delivering an intervention will likewise be blinded to the contents of the parallel intervention, and to the superiority framework. Outcomes assessors: Staff collecting objective outcome data are blinded to group allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Coordinator

Model Details: The trial is a single-center pragmatic, double-blinded randomized controlled superiority trial, with a two-group parallel arm design and 1:1 group allocation ratio.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 30, 2021
• Study Start: January 1, 2022
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

DK (1)