To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Using medical biological glue for filling And Using the meniscus suture system
Using the meniscus suture system
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
MOCART score
Time frame: Baseline (Before treatment), 6 and 12 months after treatment
Lysholm score
Time frame: Baseline (Before treatment), 3、 6 and 12 months after treatment
IKDC score
Time frame: Baseline (Before treatment), 3、 6 and 12 months after treatment
T2 mapping
Time frame: Baseline (Before treatment),12 months after treatment
Equipment use and evaluation
Time frame: During operation
The occurrence of adverse events related to the test device
Time frame: 12 months after treatment
The incidence of device related SAE requiring further surgical intervention within 12 months after surgical
Time frame: 12 months after treatment
Equipment defect incidence rate
Time frame: During operation
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