Clinical trial NCT02824172: Treatment of the Osgood Schlatter
Official title: Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osgood Schlatter Disease
Keywords: Cast immobilization
Complete rest
Osgood Schlatter
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Restarting a sporting activity
timeFrame: 12 weeks after intervention
Secondary outcomes:
measure: Anterior tibial tuberosity pain
timeFrame: Inclusion visit Day 0
measure: Anterior tibial tuberosity pain
timeFrame: follow-up visit week 4
measure: Anterior tibial tuberosity pain
timeFrame: follow-up visit week 8
measure: Anterior tibial tuberosity pain
timeFrame: follow-up visit week 12
measure: Pain killer consumption
timeFrame: follow-up visit week 4
measure: Pain killer consumption
timeFrame: follow-up visit week 8
measure: Quality of life assessment
timeFrame: inclusion visit Day 0
measure: Quality of life assessment
timeFrame: follow-up visit week 12
measure: Quality of life assessment
timeFrame: follow-up visit month 6
measure: Activity level assessment
timeFrame: inclusion visit Day 0
measure: Activity level assessment
timeFrame: follow-up visit week 12
measure: Activity level assessment
timeFrame: follow-up visit month 6
measure: complete sport rest compliance assessment
timeFrame: follow-up visit week 4
measure: painfulness due to immobilization cast
timeFrame: follow-up visit week 12
measure: Quadricipital shortness
timeFrame: inclusion visit Day 0
measure: Quadricipital shortness
timeFrame: follow-up visit week 4
measure: Quadricipital shortness
timeFrame: follow-up visit week 8
measure: Patella size
timeFrame: inclusion visit Day 0
measure: Patella size
timeFrame: follow-up visit week 8
measure: Radiographic evolution of Osgood Schlatter disease
timeFrame: follow-up visit week 12
measure: Potential return to sport activity
timeFrame: follow visit week 8
measure: Return to sport activity at the initial level
timeFrame: follow visit month 6
measure: alternative options during the study
timeFrame: follow visit month 6
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
Study officials:
affiliation: Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon
name: Jean-Francois LUCCIANI, MD
role: PRINCIPAL_INVESTIGATOR
References: