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Enrolling by Invitation

NCT Number: NCT06878794

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

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

Enrolling by Invitation

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Combination Product

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

Using the meniscus suture system

Procedure

Using the meniscus suture system

Primary outcomes

  1. MOCART score

    Time frame: Baseline (Before treatment), 6 and 12 months after treatment

  2. Lysholm score

    Time frame: Baseline (Before treatment), 3、 6 and 12 months after treatment

  3. IKDC score

    Time frame: Baseline (Before treatment), 3、 6 and 12 months after treatment

Secondary outcomes

  1. T2 mapping

    Time frame: Baseline (Before treatment),12 months after treatment

  2. Equipment use and evaluation

    Time frame: During operation

  3. The occurrence of adverse events related to the test device

    Time frame: 12 months after treatment

  4. The incidence of device related SAE requiring further surgical intervention within 12 months after surgical

    Time frame: 12 months after treatment

  5. Equipment defect incidence rate

    Time frame: During operation

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Collaborators

  • The First Affiliated Hospital of Xinxiang Medical College

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.