Osgood Schlatter DiseaseOSGOODNCT02824172
Treatment of the Osgood Schlatter
A study testing cast immobilization group and complete sport rest. in people with Osgood Schlatter Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Osgood Schlatter Disease
- What is being tested?
- cast immobilization group and complete sport rest.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- Agreed to participate
- Agreement of the parents to participate
- Affiliation to national security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
Lyon, 69003
About this study
Official title: Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study
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.
Read more
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
- Conditions
- Osgood Schlatter Disease
- Being tested
- cast immobilization group, complete sport rest.
- Keywords
- Cast immobilization, Complete rest, Osgood Schlatter
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cast immobilization groupOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Cast immobilization | Experimental | 36 patients in the experimental cast immobilization Receives: Other: cast immobilization group |
| complete sport rest | Active comparator | 36 patients in the complete sport rest group Receives: Other: complete sport rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restarting a sporting activity
Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment.
Measured: 12 weeks after intervention
Secondary outcomes (23)
Anterior tibial tuberosity pain
Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
Measured: Inclusion visit Day 0
Anterior tibial tuberosity pain
Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
Measured: follow-up visit week 4
Anterior tibial tuberosity pain
Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
Measured: follow-up visit week 8
Anterior tibial tuberosity pain
Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
Measured: follow-up visit week 12
Pain killer consumption
Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
Measured: follow-up visit week 4
Pain killer consumption
Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
Measured: follow-up visit week 8
Quality of life assessment
Quality of life will be assessed using the SF-12 auto questionnaire
Measured: inclusion visit Day 0
Quality of life assessment
Quality of life will be assessed using the SF-12 auto questionnaire
Measured: follow-up visit week 12
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
Measured: follow-up visit month 6
Activity level assessment
Activity level will be assessed using the Tegner scale
Measured: inclusion visit Day 0
Activity level assessment
Activity level will be assessed using the Tegner scale
Measured: follow-up visit week 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
Measured: follow-up visit month 6
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)
Measured: follow-up visit week 4
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.
Measured: follow-up visit week 12
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
Measured: inclusion visit Day 0
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
Measured: follow-up visit week 4
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
Measured: follow-up visit week 8
Patella size
The patella size will be measure on the lateral radiograph using the Caton and Deschamp index
Measured: inclusion visit Day 0
Patella size
The patella size will be measure on the lateral radiograph using the Caton and Deschamp index
Measured: follow-up visit week 8
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.
Measured: follow-up visit week 12
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
Measured: follow visit week 8
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
Measured: follow visit month 6
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.
Measured: follow visit month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osgood Schlatter DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Francois LUCCIANI, MD, Principal investigator, Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824172
- Sponsor's protocol ID
- 69HCL16_0404
- Acronym
- OSGOOD
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02824172
- Acronym / sponsor ID
- OSGOOD / 69HCL16_0404
- Conditions
- Osgood Schlatter Disease
- Keywords
- Cast immobilization, Complete rest, Osgood Schlatter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast immobilization | Experimental | Other: cast immobilization group36 patients in the experimental cast immobilization |
| complete sport rest | Active comparator | Other: complete sport rest.36 patients in the complete sport rest group |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cast immobilization groupPatients 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. | Other | Cast immobilization |
| complete 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 . | Other | complete sport rest |
Primary outcome
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.
23 secondary outcomes
Anterior tibial tuberosity pain
Time frame: Inclusion visit Day 0
Anterior tibial tuberosity pain
Time frame: follow-up visit week 4
Anterior tibial tuberosity pain
Time frame: follow-up visit week 8
Anterior tibial tuberosity pain
Time frame: follow-up visit week 12
Pain killer consumption
Time frame: follow-up visit week 4
Pain killer consumption
Time frame: follow-up visit week 8
Quality of life assessment
Time frame: inclusion visit Day 0
Quality of life assessment
Time frame: follow-up visit week 12
Quality of life assessment
Time frame: follow-up visit month 6
Activity level assessment
Time frame: inclusion visit Day 0
Activity level assessment
Time frame: follow-up visit week 12
Activity level assessment
Time frame: follow-up visit month 6
complete sport rest compliance assessment
Time frame: follow-up visit week 4
painfulness due to immobilization cast
Time frame: follow-up visit week 12
Quadricipital shortness
Time frame: inclusion visit Day 0
Quadricipital shortness
Time frame: follow-up visit week 4
Quadricipital shortness
Time frame: follow-up visit week 8
Patella size
Time frame: inclusion visit Day 0
Patella size
Time frame: follow-up visit week 8
Radiographic evolution of Osgood Schlatter disease
Time frame: follow-up visit week 12
Potential return to sport activity
Time frame: follow visit week 8
Return to sport activity at the initial level
Time frame: follow visit month 6
alternative options during the study
Time frame: follow visit month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publicationDuperron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Francois LUCCIANI, MD principal investigator
Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cast immobilization group and complete sport rest. in people with Osgood Schlatter Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restarting a sporting activity (time frame: 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.