Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Proportion of patients operated at 45 days
研究概览
简要总结
The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information.
详细描述
As part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). Patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical PEC, will also be followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rupture, partial or complete, of the anterior cruciate ligament less than 3 months old (confirmed by magnetic resonance imaging);
- •Patient with no contraindication to surgery or functional management, according to the medical team;
- •Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study
- •Patient benefiting from a social security scheme;
排除标准
- •Grade 3 associated ligament injury on the fibular collateral ligament and/or the tibial collateral ligament;
- •Symptomatic meniscal lesion;
- •Practice of sport in national or international competition ;
- •Recurrence of rupture of the same anterior cruciate ligament;
- •Patient with a neurological (motor and/or sensory), vestibular or rheumatic pathology;
- •Pregnant woman ;
- •Protected adult patient (under guardianship, or under a regime of deprivation of liberty).
研究组 & 干预措施
Type of management, surgical or functional, after rupture of the anterior cruciate ligament
Patients will choose the type of management, surgical or functional, after rupture of the anterior cruciate ligament.
干预措施: Functional or surgical management in 1st intention (Procedure)
结局指标
主要结局
Proportion of patients operated at 45 days
时间窗: 45 days
Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture
次要结局
- Proportion of patients who persist in the choice of non-surgical(12 months)