Treatment of the Osgood Schlatter

Study Overview
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Brief Summary
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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

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

Conditions
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Osgood Schlatter Disease

Intervention / Treatment
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* Other: cast immobilization group
* Other: complete sport rest.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cast immobilization<br>36 patients in the experimental cast immobilization | Other: cast immobilization group<br>* 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.<br>|
| Active Comparator: complete sport rest<br>36 patients in the complete sport rest group | Other: complete sport rest.<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restarting a sporting activity | Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment. | 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior tibial tuberosity pain | Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation | Inclusion visit Day 0 | 
| Anterior tibial tuberosity pain | Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation | 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 | 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 | follow-up visit week 12 | 
| Pain killer consumption | Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups | follow-up visit week 4 | 
| Pain killer consumption | Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups | follow-up visit week 8 | 
| Quality of life assessment | Quality of life will be assessed using the SF-12 auto questionnaire | inclusion visit Day 0 | 
| Quality of life assessment | Quality of life will be assessed using the SF-12 auto questionnaire | 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 | follow-up visit month 6 | 
| Activity level assessment | Activity level will be assessed using the Tegner scale | inclusion visit Day 0 | 
| Activity level assessment | Activity level will be assessed using the Tegner scale | 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 | 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) | 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. | 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 | 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 | 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 | follow-up visit week 8 | 
| Patella size | The patella size will be measure on the lateral radiograph using the Caton and Deschamp index | inclusion visit Day 0 | 
| Patella size | The patella size will be measure on the lateral radiograph using the Caton and Deschamp index | 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. | 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 | 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 | 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. | follow visit month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cast immobilization, Complete rest, Osgood Schlatter