Clinical Trial: Treatment of the Osgood Schlatter

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Hospices Civils de Lyon

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anterior tibial tuberosity pain [ Time Frame: Inclusion visit Day 0 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
  • Anterior tibial tuberosity pain [ Time Frame: follow-up visit week 4 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
  • Anterior tibial tuberosity pain [ Time Frame: follow-up visit week 8 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
  • Anterior tibial tuberosity pain [ Time Frame: follow-up visit week 12 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation
  • Pain killer consumption [ Time Frame: follow-up visit week 4 ]
    Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
  • Pain killer consumption [ Time Frame: follow-up visit week 8 ]
    Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
  • Quality of life assessment [ Time Frame: inclusion visit Day 0 ]
    Quality of life will be assessed using the SF-12 auto questionnaire
  • Quality of life assessment [ Time Frame: follow-up visit week 12 ]
    Quality of life will be assessed using the SF-12 auto questionnaire
  • Quality of life assessment [ Time Frame: 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
  • Activity level assessment [ Time Frame: inclusion visit Day 0 ]
    Activity level will be assessed using the Tegner scale
  • Activity level assessment [ Time Frame: follow-up visit week 12 ]
    Activity level will be assessed using the Tegner scale
  • Activity level assessment [ Time Frame: 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 [ Time Frame: 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)
  • painfulness due to immobilization cast [ Time Frame: 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 [ Time Frame: inclusion visit Day 0 ]
    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
  • Quadricipital shortness [ Time Frame: follow-up visit week 4 ]
    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
  • Quadricipital shortness [ Time Frame: 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
  • Patella size [ Time Frame: inclusion visit Day 0 ]
    The patella size will be measure on the lateral radiograph using the Caton and Deschamp index
  • Patella size [ Time Frame: follow-up visit week 8 ]
    The patella size will be measure on the lateral radiograph using the Caton and Deschamp index
  • Radiographic evolution of Osgood Schlatter disease [ Time Frame: 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.
  • Potential return to sport activity [ 

    Original Secondary Outcome: Same as current

    Information By: Hospices Civils de Lyon

    Dates:
    Date Received: June 29, 2016
    Date Started: September 2015
    Date Completion: December 2016
    Last Updated: July 1, 2016
    Last Verified: June 2016