Treatment of Acute ACL Injuries in Young Patients Using a Rebound ACL Brace
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Objective knee function
研究概览
简要总结
This study evaluates the use of a brace in acute anterior cruciate ligament (ACL) injuries in children and adolescents. Half of the participants will receive a so called rebound ACL brace together with a standardized rehab program supervised by a physiotherapist, while the other half will receive only the standardized rehab program supervised by a physiotherapist
详细描述
A well known treatment of posterior cruciate ligament injuries in the acute phase is a brace which pushes the tibia anteriorly, and the result of the treatment is often successful with healing of the ligament. Similarly, in anterior cruciate ligament injuries, it is suggested that a rebound ACL brace which pushes the tibia posteriorly can facilitate healing of the ACL. It does not have as successful treatment results as the PCL brace, but the type and location of the ACL injury has in previous studies not been well defined. We will, after having described the localisation and type of ACL injury treat the intervention group with the rebound ACL brace and a standardized rehab program and the control group with standardized rehab program alone.
The randomization is made blockwise of 4, to treatment A= Brace+physiotherapy or B=Physioterapy. The groups are stratified for gender and age (<=14 years and >14 years)
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
- Single (Outcomes Assessor)
盲法说明
The knee laxity measurement with KT-1000 will be performed by an assessor without knowledge of type of intervention. Other outcome measures will not be masked.
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No previous significant knee injury
- •Trauma followed by hemarthrosis and clinical suspicion of an acute ACL injury
- •Acute ACL rupture seen on MRI
排除标准
- •Previous ipsilateral knee surgery
- •Associated injuries which require early surgical intervention
结局指标
主要结局
Objective knee function
时间窗: 24 months
laxity measurement (KT-1000)
objective knee function
时间窗: 24 months
muscle strength (measured by Biodex)
次要结局
- Activity level(6, 12 and 24 months)
- Subjective knee function(6, 12 and 24 months)
研究者
Frida Hansson, MD
MD. Principal Investigator. PhD student
Karolinska Institutet