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Completed

NCT Number: NCT02824172

Treatment of the Osgood Schlatter

The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases there is persistent residual pain in adulthood.

The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who continued his sports without restriction.

The possible consequences are numerous including the presence of a free bone fragment at the insertion of the tendon originally described by Osgood the establishment of a genu recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying sport.

The main two treatments are complete rest from sport activity or cast immobilization.

The main objective is to compare these two technics according to the proportion of full sporting recovering at 12 months

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Key information

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Boys and girls
  • From 9 to 15 years old
  • Coming to consult in the Sports' medicine ward
  • Patients diagnosed with Osgood-Schlatter disease defined by a swelling of the anterior tibial tuberosity (ATT) , pain on palpation of the ATT , pain with passive knee flexion , pain thwarted knee extension and soft rays in profile knee radiography according to the classification of Woolfrey and Chandler (types A -C
  • Unilateral or bilateral
  • Previously treated or not
  • Agreed to participate
  • Agreement of the parents to participate
  • Affiliation to national security

Exclusion criteria

  • Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
  • Local infection
  • Hypothermia <32°C
  • Need for implementation of arterial catheter only
  • Need for implementation of venous catheter only

Treatment and study plan

cast immobilization group

Other

Patients in this group will have their knee locked with a resin going from the ankle to the top of the thigh for 4 weeks, followed by 4 weeks without cast but with rehabilitation through physiotherapy.

complete sport rest.

Other

Patients included in this group will follow the current standard procedure for this disease that is to say complete sport rest during 8 weeks including rehabilitation through physiotherapy, following the exact same technic as the experimental group .

Primary outcomes

  1. Restarting a sporting activity

    Time frame: 12 weeks after intervention

    Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment.

Secondary outcomes

  1. Anterior tibial tuberosity pain

    Time frame: Inclusion visit Day 0

    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  2. Anterior tibial tuberosity pain

    Time frame: follow-up visit week 4

    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  3. Anterior tibial tuberosity pain

    Time frame: follow-up visit week 8

    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  4. Anterior tibial tuberosity pain

    Time frame: follow-up visit week 12

    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  5. Pain killer consumption

    Time frame: follow-up visit week 4

    Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups

  6. Pain killer consumption

    Time frame: follow-up visit week 8

    Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups

  7. Quality of life assessment

    Time frame: inclusion visit Day 0

    Quality of life will be assessed using the SF-12 auto questionnaire

  8. Quality of life assessment

    Time frame: follow-up visit week 12

    Quality of life will be assessed using the SF-12 auto questionnaire

  9. Quality of life assessment

    Time frame: follow-up visit month 6

    Quality of life will be assessed using the SF-12 auto questionnaire. As the standard follow-up visit are over, this questionnaire will be asked by phone

  10. Activity level assessment

    Time frame: inclusion visit Day 0

    Activity level will be assessed using the Tegner scale

  11. Activity level assessment

    Time frame: follow-up visit week 12

    Activity level will be assessed using the Tegner scale

  12. Activity level assessment

    Time frame: follow-up visit month 6

    Activity level will be assessed using the Tegner scale. As the standard follow-up visit are over, this scale will be asked by phone

  13. complete sport rest compliance assessment

    Time frame: follow-up visit week 4

    The complete sport rest compliance will be assessed using a visual analogic scale (0 to 10, 0 will be a complete rest compliance)

  14. painfulness due to immobilization cast

    Time frame: follow-up visit week 12

    The patient in the cast immobilization group will be asked what was the level his/her level of cast tolerance: bad, average, good or very good.

  15. Quadricipital shortness

    Time frame: inclusion visit Day 0

    The Quadricipital shortness will be evaluated thanks to the knee flexion angle will be measured using the modified Thomas test as well as hamstring muscles length measured using the popliteal angle

  16. Quadricipital shortness

    Time frame: follow-up visit week 4

    The Quadricipital shortness will be evaluated thanks to the knee flexion angle will be measured using the modified Thomas test as well as hamstring muscles length measured using the popliteal angle

  17. Quadricipital shortness

    Time frame: follow-up visit week 8

    The Quadricipital shortness will be evaluated thanks to the knee flexion angle will be measured using the modified Thomas test as well as hamstring muscles length measured using the popliteal angle

  18. Patella size

    Time frame: inclusion visit Day 0

    The patella size will be measure on the lateral radiograph using the Caton and Deschamp index

  19. Patella size

    Time frame: follow-up visit week 8

    The patella size will be measure on the lateral radiograph using the Caton and Deschamp index

  20. Radiographic evolution of Osgood Schlatter disease

    Time frame: follow-up visit week 12

    Both clinicians and radiologist will evaluate separately the evolution of Osgood Schlatter disease using a new classification. It is based on 3 parameters: anterior tibial tuberosity fragmentation, thickening of soft tissues and presence or not of an ossicle.

  21. Potential return to sport activity

    Time frame: follow visit week 8

    After a week of training, patients of each group will be evaluated and the clinician will consider the possibility of a potential return to sport activity the week 8 of follow-up

  22. Return to sport activity at the initial level

    Time frame: follow visit month 6

    Six months after the intervention, patients will be called to evaluate if they were able to return to a sport activity at the same level they were before the disease. This proportion will be compared in between both groups

  23. alternative options during the study

    Time frame: follow visit month 6

    Each patient will be ask during the phone interview at 6 months if the consulted another physicians or if they used an alternative to that proposed in our study.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study

Acronym: OSGOOD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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