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

NCT06878794•First Affiliated Hospital of Ningbo University

Summary

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

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

•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.

Locations (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Key Dates

Start Date

December 25, 2024

Primary Completion Date

November 30, 2026

Completion Date

November 30, 2026

Last Updated

March 17, 2025

Enrollment

ESTIMATED participants

Conditions

Unilateral Meniscus Tear of the Knee Joint

Interventions

Using medical biological glue for filling And Using the meniscus suture system

COMBINATION_PRODUCT

Using the meniscus suture system

PROCEDURE