Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese (NCT04012567) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
China140 participantsStarted 2019-12-17
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
Exclusion criteria
✕. 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;