"Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Rerupture rate
研究概览
简要总结
This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction.
The primary outcome is the rate of rupture of the anterior cruciate ligament as measured by the Lachmann test in which a positive value for re-rupture is an anterior translation of the tibia greater than 10mm relative to the femur Secondary Objectives: Verify predisposing factors to anterior cruciate ligament injuries (so anatomical factors such as tibial slope, trochlear groove), demographic factors (age, sex, weight, sports played), and the rate of return to sports, quality of life via questionnaires, and arthrosis at the operated knee
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Males and females- attained skeletal maturity
- •18-65 inclusive
- •Patients operated on anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
- •Signature informed consent for patients who will be operated on in the prospective phase (from CE approval date to 2030)
排除标准
- •failure to reach skeletal maturity
- •Concomitant ligamentous injuries (pcl, mcl, lcl)
- •Neuropsychiatric illness, developmental disorders
- •Pregnant women through self-declaration or breastfeeding
结局指标
主要结局
Rerupture rate
时间窗: 10 years
rate of rerupture rare evaluated with anterior tibial translation
次要结局
未报告次要终点