Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Classification of RMI signal
研究概览
简要总结
This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery.
As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive activities, by analysis of RMI signal and biomechanic features modifications.
As secondary objectives, the study aims to:
- study the correlation between the RMI signal of plasty and the Young's modulus;
- study the evolution of RMI of plasty at M3, M6 and M12;
- study the evolution of Young's modulus at M3, M6 and M12;
- evaluate the reproductibility between 2 lector of RMI measurements;
- evaluate the reproductibility between 2 lector of elastography measurements of LTFA;
- evaluate the optimal delay of return to sport after ligament plasty surgery of ankle;
- develope a score of type SNQ for ankle ligament plasty surgery;
- evolution of AOFAS and EVA scores.
详细描述
The eligible patients will be enrolled in the department of orthopaedic surgery of Ambroise Paré hospital, each patient will undergo a 12-months follow-up in the department of orthopaedic surgery in Armand Trousseau hospital for the elastography evaluations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy;
- •Affiliated to or covered by the French social security - welfare system in France;
- •Have provided written informed consent for the study;
- •Be >/= 18 years of age on day of signing informed consent.
排除标准
- •Patients who undergo iterative surgery or have history of contralateral surgery;
- •Patient under guardianship or curatorship;
- •Unable to understand the proposed study or provide written informed consent for the study;
- •Foreign patients under AME schema, a medical help from the state in France;
- •Pregnant or breastfeeding woman;
- •Patient refusal.
结局指标
主要结局
Classification of RMI signal
时间窗: At 12 months
The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Classification of RMI signal
时间窗: At 3 months
The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Classification of RMI signal
时间窗: At 6 months
The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4.
次要结局
- Anterior talofibular ligament measurement(At 3, 6 and 12 months)
- Elastography(At 3, 6 and 12 months)
- Calcaneofibular ligament measurement(At 3, 6 and 12 months)
- Pain evaluation(At baseline and 3, 6 and 12 months)