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

Launched by FIRST AFFILIATED HOSPITAL OF NINGBO UNIVERSITY · Mar 13, 2025

Keywords

ClinConnect Summary

This study is testing a water-activated medical glue (a bioadhesive) used to repair a torn meniscus in the knee. It compares glue plus the usual meniscus suturing to the usual suturing alone. The trial is randomized (people are assigned by chance to one of the two groups) and plans to enroll about 60 adults ages 18–60 with a single knee meniscus tear. It’s being conducted at The First Affiliated Hospital of Ningbo University in Ningbo, China, and is currently enrolling by invitation. No results are available yet, and the study aims to complete its main data collection by late 2026.

If you participate, you’ll be randomly placed in either the experimental group (glue plus suturing) or the control group (suturing only). Researchers will follow you for about 12 months, checking your knee function at several points and using MRI scans to look at healing. They’ll measure knee function with standard scores and monitor safety, including any adverse device events or need for additional surgery within 12 months. To be eligible, you must be 18–60 with a unilateral knee meniscus tear and normal knee motion, and you must consent to participate. Exclusion criteria include BMI over 32, certain alignment or cartilage problems, multiple ligament injuries or recent knee surgery, allergy to the glue, pregnancy, infection or immune/metabolic knee conditions, or participation in another trial within the past 3 months.

Gender

ALL

Eligibility criteria

• 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.