Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- percentage of patients with Lysholm score more than 70 score
研究概览
简要总结
Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions.
120 Subjects with ACL injury were randomly assigned to two groups for ACL reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference screw (Smith & Nephew plc). The subjects will be followed by 12 months after surgery for evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form; Between the ages of 18 and 75; Positive ADT and positive Lachman test. Unilateral anterior cruciate ligament is confirmed by MRI (without posterior cruciate ligament injury or reconstruction); Tolerated for anterior cruciate ligament reconstruction surgery; Normal contralateral knee
排除标准
- •Do not meet the diagnostic criteria of anterior cruciate ligament injury;
- •With posterior cruciate ligament fracture at the same time;
- •X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury);
- •Knee flexion less than 90 degree;
- •Abnormal body anatomy;
- •Pregnant, breast-feeding or subjects who plan to become pregnant;
- •Serious osteoporosis, malignant tumors;
- •Allergic to implant materials;
- •Patients with severe malnutrition who can not tolerate surgery;
- •Severe coagulopathy, such as hemophilia;
- •Immunodeficiency diseases, including those requiring long-term use of immunosuppressive agents;
- •The injured knee has a wide range of skin diseases;
- •Serious obese patients (BMI> 35);
- •Patients with severe mental illness can not cooperate with postoperative rehabilitation and patients with severe cardiopulmonary disease can not tolerate surgery;
- •Ipsilateral lower extremity received surgery within the past year;
- •Has participated in any other clinical trial in the past three months;
- •Can not comply with the requirements of the study;
- •Those who the investigator thinks they are inappropriate.
研究组 & 干预措施
PEEK Interference Screws
PEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd.
干预措施: Interference Screws (Device)
Biosure PK interference screw
Biosure PK interference screw from Smith & Nephew plc.
干预措施: Interference Screws (Device)
结局指标
主要结局
percentage of patients with Lysholm score more than 70 score
时间窗: 12 month
次要结局
- Lysholm score(1month; 3month; 6 month; 12 month)
- IKDC(1month; 3month; 6 month; 12 month)
- Anterior drawer test(1month; 3month; 6 month; 12 month)
- Lachman test(1month; 3month; 6 month; 12 month)
研究者
Hongbin Lu
Porfessor
Central South University