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

First Affiliated Hospital of Ningbo University

Status

Invitation-only

Conditions

Unilateral Meniscus Tear of the Knee Joint

Treatments

Combination Product: Using medical biological glue for filling And Using the meniscus suture system

Procedure: Using the meniscus suture system

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

2024-R049-03

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.