Knee Clinical Trial
Official title:
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
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.
The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial. ;
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