Unilateral Meniscus Tear of the Knee JointNCT06878794
IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
A study testing Using medical biological glue for filling And Using the meniscus suture system and Using the meniscus suture system in people with Unilateral Meniscus Tear of the Knee Joint, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Unilateral Meniscus Tear of the Knee Joint
- What is being tested?
- Using medical biological glue for filling And Using the meniscus suture system and Using the meniscus suture system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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".
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
About this study
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
- Being tested
- Using medical biological glue for filling And Using the meniscus suture system, Using the meniscus suture system
- Keywords
- Meniscus tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using medical biological glue for filling And Using the meniscus suture systemCombination product
Using medical biological glue for filling And Using the meniscus suture system
Using the meniscus suture systemProcedure or surgery
Using the meniscus suture system
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Using the meniscus suture system Receives: Procedure: Using the meniscus suture system |
| Experimental group | Active comparator | Using medical biological glue for filling And Using the meniscus suture system Receives: Combination Product: Using medical biological glue for filling And Using the meniscus suture system |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCART score
Measured: Baseline (Before treatment), 6 and 12 months after treatment
Lysholm score
Measured: Baseline (Before treatment), 3、 6 and 12 months after treatment
IKDC score
Measured: Baseline (Before treatment), 3、 6 and 12 months after treatment
Secondary outcomes (5)
T2 mapping
Measured: Baseline (Before treatment),12 months after treatment
Equipment use and evaluation
Measured: During operation
The occurrence of adverse events related to the test device
Measured: 12 months after treatment
The incidence of device related SAE requiring further surgical intervention within 12 months after surgical
Measured: 12 months after treatment
Equipment defect incidence rate
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start25 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Meniscus Tear of the Knee JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Collaborators
- The First Affiliated Hospital of Xinxiang Medical College
- Responsible party
- Sponsor
- Investigators
- Jiang Zhu, Study chair, First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878794
- Sponsor's protocol ID
- 2024-R049-03
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
- ClinicalTrials.gov ID
- NCT06878794
- Acronym / sponsor ID
- 2024-R049-03
- Keywords
- Meniscus tear
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Collaborators
- The First Affiliated Hospital of Xinxiang Medical College
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: Using the meniscus suture systemUsing the meniscus suture system |
| Experimental group | Active comparator | Combination Product: Using medical biological glue for filling And Using the meniscus suture systemUsing medical biological glue for filling And Using the meniscus suture system |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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".
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using medical biological glue for filling And Using the meniscus suture systemUsing medical biological glue for filling And Using the meniscus suture system | Combination product | Experimental group |
| Using the meniscus suture systemUsing the meniscus suture system | Procedure or surgery | Control group |
Primary outcome
MOCART score
Time frame: Baseline (Before treatment), 6 and 12 months after treatment
Lysholm score
Time frame: Baseline (Before treatment), 3、 6 and 12 months after treatment
IKDC score
Time frame: Baseline (Before treatment), 3、 6 and 12 months after treatment
5 secondary outcomes
T2 mapping
Time frame: Baseline (Before treatment),12 months after treatment
Equipment use and evaluation
Time frame: During operation
The occurrence of adverse events related to the test device
Time frame: 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
Equipment defect incidence rate
Time frame: During operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiang Zhu study chair
First Affiliated Hospital of Ningbo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using medical biological glue for filling And Using the meniscus suture system and Using the meniscus suture system in people with Unilateral Meniscus Tear of the Knee Joint, run by First Affiliated Hospital of Ningbo University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCART score (time frame: Baseline (Before treatment), 6 and 12 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.