NCT05174182

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

A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	A novel treatment approach	A novel treatment approach, as described before.
OTHER	Usual care	Usual care, as described before.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-03-08
• Completion: 2024-03-08
• First posted: 2021-12-30
• Last updated: 2025-04-11

Locations

1 site across 1 country: Denmark