Treatment of the Osgood Schlatter

Not Applicable

Completed

• Conditions: Osgood Schlatter Disease
• Interventions: Other: cast immobilization group; Other: complete sport rest.

• Registration Number: NCT02824172
• Lead Sponsor: Hospices Civils de Lyon

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cast immobilization	cast immobilization group	36 patients in the experimental cast immobilization
complete sport rest	complete sport rest.	36 patients in the complete sport rest group

Primary Outcome Measures

Name	Time	Method
Restarting a sporting activity	12 weeks after intervention	Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment	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
Anterior tibial tuberosity pain	follow-up visit week 12	Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
Radiographic evolution of Osgood Schlatter disease	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.
Activity level assessment	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
complete sport rest compliance assessment	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)
Potential return to sport activity	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
alternative options during the study	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.
Patella size	follow-up visit week 8	The patella size will be measure on the lateral radiograph using the Caton and Deschamp index
Return to sport activity at the initial level	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
Pain killer consumption	follow-up visit week 8	Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
painfulness due to immobilization cast	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.
Quadricipital shortness	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

Trial Locations

Locations (1)

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