Unilateral Meniscus Tear of the Knee Joint
Conditions
Keywords
Meniscus tear
Brief summary
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
Interventions
COMBINATION_PRODUCTUsing medical biological glue for filling And Using the meniscus suture system
Using medical biological glue for filling And Using the meniscus suture system
PROCEDUREUsing the meniscus suture system
Using the meniscus suture system
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
First Affiliated Hospital of Ningbo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 1\. The patient is aged between 18 and 60 years old (including 18 and 60 years old), regardless of gender; 2. Unilateral meniscus tear of the knee joint; 3. Normal joint range of motion; 4. The subjects agree to participate in this trial and sign the Subject Informed Consent Form.
Exclusion criteria
* 1\. Body mass index BMI\>32 kg/m2 (BMI=weight divided by height squared); 2. Patients with abnormal lower limb force lines that require correction; 3. Patients with multiple ligament injuries or complete meniscectomy; 4. Individuals with a history of allergies to biological glue as the chief complaint; 5. Patients with more than 2 or extensive cartilage defects in a single knee joint, and patients with bilateral knee joint cartilage defects; 6. Those who have undergone open knee surgery within the past 6 months; 7. Pregnant or lactating women, or those who plan to conceive during the trial period, and those whose blood HCG test results are positive before the trial; 8. Patients with infectious, immune, or metabolic arthritis in the knee joint; 9. Patients who participated in any other clinical trial or did not reach the trial endpoint within the first 3 months prior to enrollment; 10. Other circumstances determined by the researcher to be unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of device related SAE requiring further surgical intervention within 12 months after surgical | 12 months after treatment |
| T2 mapping | Baseline (Before treatment),12 months after treatment |
| Equipment defect incidence rate | During operation |
| Equipment use and evaluation | During operation |
| The occurrence of adverse events related to the test device | 12 months after treatment |
Countries
China
Outcome results
None listed