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

Date de début de l'étude : 17 décembre 2019

Inclusion Criteria: * Subjects must meet all of the inclusion criteria: 1. Signing the Informed Consent Form (ICF) voluntarily; 2. Patients aged 18-75 years; 3. Patients clinically diagnosed with knee cruciate ligaments rupture or tear and suitable for cruciate ligaments reconstruction definitely; 4. Normal contralateral knee joint. Exclusion Criteria: * Subjects with any of the following characteristics must be excluded from participation in the study: 1. Patients not complying with the diagnosis criteria for cruciate ligaments rupture or tear; 2. Patients with an unclosed epiphyseal plate shown on the X-ray film; 3. Patients having underwent internal fixation or reconstruction due to a knee joint fracture; 4. Patients with obvious knee joint degeneration shown on the X-ray film; 5. Patients who cannot make a knee flexion of not less than 90° during operation; 6. Patients undergoing autologous chondrocyte implantation; 7. Patients with medial meniscus or lateral meniscus completely resected; 8. Patients with significant anatomical abnormalities; 9. Pregnant or breast-feeding females or those at a child-bearing age planning to become pregnant; 10. Patients with serious osteoporosis that affects screw implantation; 11. Patients with a malignant tumor that causes failure to effectively fix the implant; 12. Known hypersensitivity to the implant materials; 13. Patients not suitable for operation due to obvious local or systemic infection; 14. Patients who cannot tolerate an operation due to severe malnutrition; 15. Patients with severe coagulation disorder (judged by the investigator), e.g. the hemophiliac; 16. Patients with immunodeficiency, including those who must receive immunosuppressant for a long time; 17. Patients with extensive skin diseases; 18. Obese patients having a Body Mass Index (BMI) \> 35; 19. 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; 20. Patients who received operation on the injured lower limb within the past 1 year; 21. Patients who participated in any other clinical trial within the past three months; 22. Patients who cannot follow the requirements described in the study protocol; and 23. Other patients who are considered by the investigator not suitable for this clinical study.