Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- The percentage of therapeutic success, defined by the absence of extension defect at M3 post ligamentoplasty, will be compared between the groups by a Chi-2 test.
研究概览
简要总结
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring
- Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
- Group 2: placebo: 0.5 ml in 1 injection
详细描述
The study includes three assessments: one month after ligamentoplasty (inclusion visit) and then at M2 and M5. The therapeutic benefit of the study treatments is based on the evolution of the extension defect at M2.
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
- Double (Participant, Investigator)
盲法说明
A placebo is used
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
- •Patient over 18 years of age
- •Patient who has read and signed the consent form for participation in the study
- •Patient operated on for primary ACL ligamentoplasty with or without meniscal repair
- •Patient with reducible flatus >10° at 1 month post ligamentoplasty
排除标准
- •Revision ligamentoplasty
- •Multi-ligament knee
- •Patient under court protection, guardianship or trusteeship
- •Patient not affiliated to the French social security system
- •Patient participating in another therapeutic protocol
- •Pregnant woman or woman of childbearing age without effective contraception
- •Patient unable to understand the informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
- •Patient with known hypersensitivity to botulinum toxin
- •Patient with peripheral neuromuscular dysfunction or pronounced atrophy of the semitendinosus muscle
- •Patient treated with anticoagulants, chloroquine (or hydroxychloroquine)
- •Patient treated in the previous seven days with antibiotics or muscle relaxants (such as tubocurarine)
研究组 & 干预措施
Group 2
Placebo: 0.5 ml in 1 injection
干预措施: Placebo (Other)
Group 1
botulinum toxin: 100 units (0.5ml) in 1 injection
干预措施: Botulinum toxin (Drug)
结局指标
主要结局
The percentage of therapeutic success, defined by the absence of extension defect at M3 post ligamentoplasty, will be compared between the groups by a Chi-2 test.
时间窗: Month 2
Therapeutic success is defined by the absence of extension defect (0 degree of flessum) at 2 months post botulinum toxin injection
次要结局
未报告次要终点