Clinical trial NCT06878794: IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
Official title: IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Unilateral Meniscus Tear of the Knee Joint
Keywords: Meniscus tear
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
Collaborators: name: The First Affiliated Hospital of Xinxiang Medical College
First posted: 2025-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: MOCART score
timeFrame: Baseline (Before treatment), 6 and 12 months after treatment
measure: Lysholm score
timeFrame: Baseline (Before treatment), 3、 6 and 12 months after treatment
measure: IKDC score
timeFrame: Baseline (Before treatment), 3、 6 and 12 months after treatment
Secondary outcomes:
measure: T2 mapping
timeFrame: Baseline (Before treatment),12 months after treatment
measure: Equipment use and evaluation
timeFrame: During operation
measure: The occurrence of adverse events related to the test device
timeFrame: 12 months after treatment
measure: The incidence of device related SAE requiring further surgical intervention within 12 months after surgical
timeFrame: 12 months after treatment
measure: Equipment defect incidence rate
timeFrame: During operation
Other outcomes:
Locations:
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Ningbo University
name: Jiang Zhu
role: STUDY_CHAIR
References: