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

Hvidovre University Hospital

Status: Completed

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

Treatments: Other: A novel treatment approach; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05174182

H-21028912

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

A novel treatment approach

Experimental group

Description:

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.

Treatment:

Other: A novel treatment approach

Usual care

Active Comparator group

Description:

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).

Treatment:

Other: Usual care