Clinical and Radiological Evaluation of Anterior Cruciate Ligament Reconstruction Surgery With Follow-up at Least 1 Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Magnetic Resonance Imaging (MRI) of Graft
研究概览
简要总结
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.
详细描述
The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the outcomes remains largely debated. The study aims to analyze the potentially individual and operative parameters and identify the factors responsible for the clinical and radiological outcomes. In addition to collecting patient data in terms of features and clinical-radiological status, objective data will be documented and correlated.
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1 years after surgery during a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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 who have provided informed written written consent;
- •Patients aged between 18 and 45;;
- •Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
排除标准
- •Patients who have not signed informed consent;
- •Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- •Revision procedures
- •Patients unable to lay still in an MRI or CT scanner
- •Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
结局指标
主要结局
Magnetic Resonance Imaging (MRI) of Graft
时间窗: 1 year
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
次要结局
- Isokinetic Dynamometer(1 year)
- Marx Activity Rating Score(1 year)
- Difference in Computed Tomography (CT) imaging of Tunnels(1 day, 6 months, 1 year)
- International Knee Documentation Committee (IKDC)(1 year)
研究者
Ahmet Emin Okutan
Specialist in Orthopaedics
Samsun University