Status:
ENROLLING_BY_INVITATION
IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
Lead Sponsor:
First Affiliated Hospital of Ningbo University
Collaborating Sponsors:
The First Affiliated Hospital of Xinxiang Medical College
Conditions:
Unilateral Meniscus Tear of the Knee Joint
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06878794
Start Date
December 25 2024
End Date
November 30 2026
Last Update
March 17 2025
Active Locations (1)
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1
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000