A Prospective, Multi-center, Randomized Clinical Study to Evaluate the Safety and Effectiveness of Biosure Regenesorb Interference Screw in Arthroscopic Reconstruction of Cruciate Ligaments in Chinese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Lysholm Knee Scoring Scale 12 Months After Operation
研究概览
简要总结
The objective of this study is to compare the safety and effectiveness of Biosure Regenesorb Interference Screw versus BIOSURE HA Interference Screw (control device) in patients requiring reconstruction of cruciate ligaments of the knee. The trial results will be used for registration of Biosure Regenesorb Interference Screw in China.
The primary efficacy endpoint of this study is Lysholm score at 12 months after operation. The non-inferiority testing is performed for efficiency of primary efficacy endpoint, and the test hypothesis is as follows:
Invalid hypothesis: H0: μ1-μ2 ≤-δ Alternative hypothesis: H1: μ1-μ2 > -δ, where, μ1 and μ2 are the Lysholm scores in the investigational group and control group, respectively. δ is a non-inferiority critical value.
详细描述
The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial.
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
- Single (Outcomes Assessor)
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
- •Subjects must meet all of the inclusion criteria:
- •Signing the Informed Consent Form (ICF) voluntarily;
- •Patients aged 18-75 years;
- •Patients clinically diagnosed with knee cruciate ligaments rupture or tear and suitable for cruciate ligaments reconstruction definitely;
- •Normal contralateral knee joint.
排除标准
- •Subjects with any of the following characteristics must be excluded from participation in the study:
- •Patients not complying with the diagnosis criteria for cruciate ligaments rupture or tear;
- •Patients with an unclosed epiphyseal plate shown on the X-ray film;
- •Patients having underwent internal fixation or reconstruction due to a knee joint fracture;
- •Patients with obvious knee joint degeneration shown on the X-ray film;
- •Patients who cannot make a knee flexion of not less than 90° during operation;
- •Patients undergoing autologous chondrocyte implantation;
- •Patients with medial meniscus or lateral meniscus completely resected;
- •Patients with significant anatomical abnormalities;
- •Pregnant or breast-feeding females or those at a child-bearing age planning to become pregnant;
- •Patients with serious osteoporosis that affects screw implantation;
- •Patients with a malignant tumor that causes failure to effectively fix the implant;
- •Known hypersensitivity to the implant materials;
- •Patients not suitable for operation due to obvious local or systemic infection;
- •Patients who cannot tolerate an operation due to severe malnutrition;
- •Patients with severe coagulation disorder (judged by the investigator), e.g. the hemophiliac;
- •Patients with immunodeficiency, including those who must receive immunosuppressant for a long time;
- •Patients with extensive skin diseases;
- •Obese patients having a Body Mass Index (BMI) > 35;
- •Patients who cannot cooperate in postoperative rehabilitation due to a severe mental disease or those who cannot tolerate the operation due to a cardiopulmonary disease;
- •Patients who received operation on the injured lower limb within the past 1 year;
- •Patients who participated in any other clinical trial within the past three months;
- •Patients who cannot follow the requirements described in the study protocol; and
- •Other patients who are considered by the investigator not suitable for this clinical study.
结局指标
主要结局
Lysholm Knee Scoring Scale 12 Months After Operation
时间窗: 12 months
Lysholm Knee Scoring Scale evaluates functions of participants based on 8 items: limp, support, interlocking, pain, instability, swelling, stair climbing and squatting. The total Lysholm score is 0-100. Pain and instability account for a higher proportion in this score. The knee functions of patients are considered excellent when the score is 95-100, good when 84-94, fair when 65-83 and poor when less than 65 (i.e., 100 is best outcome and 0 is the worst outcome).
次要结局
- Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation(Pre-Operation, Post-Operation 6 months, 24 months)
- International Knee Documentation Committee (IKDC) Score(Pre-Operation, Post-Operation 6 months, 12 months, 24 months)
- Drawer Test: Anterior(Post-Operation 6 months, 12 months, 24 months)
- Drawer Test: Posterior(Post-Operation 6 months, 12 months, 24 months)
- Lachman Test(Post-Operation 6 months, 12 months, 24 months)
- Imaging Evaluation: X-ray(Post-Operation 6 months, 12 months, 24 months)
- Imaging Evaluation: Computed Tomography (CT)(Post-Operation 6 months, 12 months, 24 months)
- Imaging Evaluation: Magnetic Resonance Imaging (MRI)(Post-Operation 6 months, 12 months, 24 months)