Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Functional performance as assessed by single-leg hop for distance test performance
研究概览
简要总结
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning.
Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations.
The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR.
Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery.
Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.
详细描述
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning.
Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations.
The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR.
Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery.
Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 45 years old
- •Tegner physical activity level between 3 and 9
- •Primary and unilateral rupture of anterior cruciate ligament, confirmed by MRI
- •patient available to carry out the preoperative re-education program
排除标准
- •Complex lesion that would impede on preoperative re-education (posterior cruciate ligament, meniscal or chondral symptomatic lesion, fracture)/
- •Neurologic or cardiorespiratory pathology contra-indicating preoperative re-education
- •Previous surgical treatment of the lower limbs or of the lumbar spine
- •Neuropathic or algodystrophic pain on the lower limbs
结局指标
主要结局
Functional performance as assessed by single-leg hop for distance test performance
时间窗: at 4 months after ACR surgery.
次要结局
- Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaire(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for)
- Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strength(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:)
- Proprioception as assessed by repositioning knee test(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:)
- Ability to return to high level athletics as assessed by single-leg hop for distance test performance(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:)
- Dynamic balance as assessed by star excursion balance test(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:)
- Physical activity level as assessed by Tegner knee scoring(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for)
- Knee anterior stability as assessed by KT-1000(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for)
- Knee symptoms as assessed by Lysholme questionnaire(at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for)