Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Restarting a sporting activity
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Restarting a sporting activity
时间窗: 12 weeks after intervention
Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment.
次要结局
- Anterior tibial tuberosity pain(follow-up visit week 12)
- Quality of life assessment(follow-up visit month 6)
- Radiographic evolution of Osgood Schlatter disease(follow-up visit week 12)
- Activity level assessment(follow-up visit month 6)
- complete sport rest compliance assessment(follow-up visit week 4)
- Potential return to sport activity(follow visit week 8)
- alternative options during the study(follow visit month 6)
- Patella size(follow-up visit week 8)
- Return to sport activity at the initial level(follow visit month 6)
- Pain killer consumption(follow-up visit week 8)
- painfulness due to immobilization cast(follow-up visit week 12)
- Quadricipital shortness(follow-up visit week 8)