Enrolling by invitation NCT06878794

IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears

No phase Interventional Unilateral Meniscus Tear of the Knee Joint

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Using medical biological glue for filling And Using the meniscus suture system, Using the meniscus suture system.
Who it may be relevant to: Registry conditions: Unilateral Meniscus Tear of the Knee Joint. Basic parameters: 18 years — 60 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair

Combination product Using medical biological glue for filling And Using the meniscus suture system
Using medical biological glue for filling And Using the meniscus suture system
Procedure Using the meniscus suture system
Using the meniscus suture system

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]

Secondary outcome measures (5)

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]

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".

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT06878794 · 2024-R049-03