ClinicalTrials.gg
CompletedNCT02824172OSGOODUpdated Dec 19, 2025

Treatment of the Osgood Schlatter

An interventional study of cast immobilization group and complete sport rest. in Osgood Schlatter Disease, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 9 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2015, registered Jun 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
9 Years to 15 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Osgood Schlatter Disease

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Keywords

  • Cast immobilization
  • Complete rest
  • Osgood Schlatter
03

In context

Osteochondrosis

16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.

This study's enrollment of 72 is above the median of 51 across 13 interventional studies indexed under Osteochondrosis.

Browse Osteochondrosis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Cast immobilization

    36 patients in the experimental cast immobilization

    Other: cast immobilization group

  • Active comparator
    complete sport rest

    36 patients in the complete sport rest group

    Other: complete sport rest.

Interventions

  • Othercast immobilization group

    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.

  • Othercomplete sport rest.

    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 .

06

What researchers measure

Primary outcomes

  1. Restarting a sporting activity

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

    Time frame: 12 weeks after intervention

Secondary outcomes

  1. Anterior tibial tuberosity pain

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

    Time frame: Inclusion visit Day 0

  2. Anterior tibial tuberosity pain

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

    Time frame: follow-up visit week 4

  3. Anterior tibial tuberosity pain

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

    Time frame: follow-up visit week 8

  4. Anterior tibial tuberosity pain

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

    Time frame: follow-up visit week 12

  5. Pain killer consumption

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

    Time frame: follow-up visit week 4

  6. Pain killer consumption

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

    Time frame: follow-up visit week 8

  7. Quality of life assessment

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

    Time frame: inclusion visit Day 0

  8. Quality of life assessment

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

    Time frame: follow-up visit week 12

  9. Quality of life assessment

    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

    Time frame: follow-up visit month 6

  10. Activity level assessment

    Activity level will be assessed using the Tegner scale

    Time frame: inclusion visit Day 0

  11. Activity level assessment

    Activity level will be assessed using the Tegner scale

    Time frame: follow-up visit week 12

  12. Activity level assessment

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

    Time frame: follow-up visit month 6

  13. complete sport rest compliance assessment

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

    Time frame: follow-up visit week 4

  14. painfulness due to immobilization cast

    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.

    Time frame: follow-up visit week 12

  15. Quadricipital shortness

    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

    Time frame: inclusion visit Day 0

  16. Quadricipital shortness

    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

    Time frame: follow-up visit week 4

  17. Quadricipital shortness

    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

    Time frame: follow-up visit week 8

  18. Patella size

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

    Time frame: inclusion visit Day 0

  19. Patella size

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

    Time frame: follow-up visit week 8

  20. Radiographic evolution of Osgood Schlatter disease

    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.

    Time frame: follow-up visit week 12

  21. Potential return to sport activity

    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

    Time frame: follow visit week 8

  22. Return to sport activity at the initial level

    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

    Time frame: follow visit month 6

  23. alternative options during the study

    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.

    Time frame: follow visit month 6

07

Study locations

1 site
  • Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
    Lyon, 69003, France
08

References and documents

Publications

  • Duperron L., Haquin A., Berthiller J., Chotel F., Pialat J-B., Luciani J-F. Étude d'une cohorte de 30 patients immobilisés avec une résine cruro-malléolaire pour une maladie d'Osgood-Schlatter. Science & Sports. 2016;31(6):323-335. doi:10.1016/j.scispo.2016.04.014.
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2015 to primary completion in Dec 2016, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2016
First posted
Jul 6, 2016
StartActual
Sep 2015
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Dec 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02824172
Responsible party
Sponsor
First posted
Jul 6, 2016
Start date
Sep 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 19, 2025

Study contacts

Jean-Francois LUCCIANI, MD
principal investigator · Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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