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

March 13, 2025 updated by: First Affiliated Hospital of Ningbo University
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • The First Affiliated Hospital of Ningbo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Using the meniscus suture system
Procedure: Using the meniscus suture system
Using the meniscus suture system
Active Comparator: Experimental group
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 medical biological glue for filling And Using the meniscus suture system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MOCART score
Time Frame: Baseline (Before treatment), 6 and 12 months after treatment
Baseline (Before treatment), 6 and 12 months after treatment
Lysholm score
Time Frame: Baseline (Before treatment), 3、 6 and 12 months after treatment
Baseline (Before treatment), 3、 6 and 12 months after treatment
IKDC score
Time Frame: Baseline (Before treatment), 3、 6 and 12 months after treatment
Baseline (Before treatment), 3、 6 and 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
T2 mapping
Time Frame: Baseline (Before treatment),12 months after treatment
Baseline (Before treatment),12 months after treatment
Equipment use and evaluation
Time Frame: During operation
During operation
The occurrence of adverse events related to the test device
Time Frame: 12 months after treatment
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
12 months after treatment
Equipment defect incidence rate
Time Frame: During operation
During operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Ningbo University

Collaborators

The First Affiliated Hospital of Xinxiang Medical College

Investigators

  • Study Chair: Jiang Zhu, First Affiliated Hospital of Ningbo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-R049-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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