IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
1 other identifier
interventional
60
1 country
1
Brief Summary
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2024
CompletedStudy Start
First participant enrolled
December 25, 2024
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
March 17, 2025
March 1, 2025
1.9 years
November 28, 2024
March 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
MOCART score
Baseline (Before treatment), 6 and 12 months after treatment
Lysholm score
Baseline (Before treatment), 3、 6 and 12 months after treatment
IKDC score
Baseline (Before treatment), 3、 6 and 12 months after treatment
Secondary Outcomes (5)
T2 mapping
Baseline (Before treatment),12 months after treatment
Equipment use and evaluation
During operation
The occurrence of adverse events related to the test device
12 months after treatment
The incidence of device related SAE requiring further surgical intervention within 12 months after surgical
12 months after treatment
Equipment defect incidence rate
During operation
Study Arms (2)
Control group
SHAM COMPARATORUsing the meniscus suture system
Experimental group
ACTIVE COMPARATORUsing medical biological glue for filling And Using the meniscus suture system
Interventions
Using medical biological glue for filling And Using the meniscus suture system
Eligibility Criteria
You may qualify if:
- \. 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".
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000, China
Study Officials
- STUDY CHAIR
Jiang Zhu
First Affiliated Hospital of Ningbo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2024
First Posted
March 17, 2025
Study Start
December 25, 2024
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
March 17, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share