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| Name | Class |
|---|---|
| The First Affiliated Hospital of Xinxiang Medical College | OTHER |
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To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Using the meniscus suture system |
|
| Experimental group | Active Comparator | Using medical biological glue for filling And Using the meniscus suture system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using medical biological glue for filling And Using the meniscus suture system | Combination Product | Using medical biological glue for filling And Using the meniscus suture system |
| Measure | Description | Time Frame |
|---|---|---|
| MOCART score | Baseline (Before treatment), 6 and 12 months after treatment | |
| Lysholm score | Baseline (Before treatment), 3、 6 and 12 months after treatment | |
| IKDC score | Baseline (Before treatment), 3、 6 and 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| T2 mapping | Baseline (Before treatment),12 months after treatment | |
| Equipment use and evaluation | During operation | |
| The occurrence of adverse events related to the test device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang Zhu | First Affiliated Hospital of Ningbo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315000 | China |
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| Using the meniscus suture system | Procedure | Using the meniscus suture system |
|
| 12 months after treatment |
| The incidence of device related SAE requiring further surgical intervention within 12 months after surgical | 12 months after treatment |
| Equipment defect incidence rate | During operation |