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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.
Cruciate Ligament Reconstruction
Investigational device: Biosure Regenesorb Interference Screw, Control device: BIOSURE HA Interference Screw
The Third Affiliated Hospital of Southern Medical University
Not yet recruiting
Smith & Nephew, Inc.
Published on BioPortfolio: 2019-07-15T10:05:49-0400
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
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