Meniscus Tear Caused by a Traumatic EventNCT06176183
A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods
A study testing Arthroscopic meniscus repair in people with Meniscus Tear Caused by a Traumatic Event and Fibrin Clot Augmentation, run by Vilnius University at 2 sites in Lithuania.
Trial summary
Performing arthroscopic meniscus repair following a traumatic meniscus tear as an alternative to a meniscectomy is now an acceptable choice. Preserving meniscus tissues is crucial due to the significant role they play as an essential part of the knee joint. Read more about this study
- Who is it for?
- Ages 0 to 19 years
- Conditions the study is for
- Meniscus Tear Caused by a Traumatic Event, Fibrin Clot Augmentation, Meniscal Repair
- What is being tested?
- Arthroscopic meniscus repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesLithuania
- Study dates
- 26 May 2021to 26 Dec 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 0 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals who provide consent to participate in the study, including patients and their care providers. The inclusion criteria for this study are as follows: being under the age of 19, having a traumatic isolated full-thickness meniscal tear longer than 1cm that has been confirmed by both preoperative MRI and arthroscopy, and not having undergone any previous surgery on the affected knee.
Who cannot join
- This investigation excludes patients with developmental disabilities who are unable to read or interpret in their native language.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania2 sites, 2 recruiting
- Recruiting
Vilnius University, Medical faculty
Vilnius, LT-03101
Viktorija Brogaite Martinkeniene, MD, 37069805546, viktorija.brogaite@mf.vu.lt
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661
Viktorija Brogaite Martinkeniene, MD, 37069805546, viktorija.brogaite@santa.lt
About this study
Official title: A Comparative Prospective Study of Meniscal Repair Methods in Young Patients With Traumatic Meniscal Tears.
Performing arthroscopic meniscus repair following a traumatic meniscus tear as an alternative to a meniscectomy is now an acceptable choice. Preserving meniscus tissues is crucial due to the significant role they play as an essential part of the knee joint. It is essential to comprehend the additional tools that can impact the recovery of the meniscus after suturing. Patients have been randomly assigned into two groups using the computer "www.randomiser.org," and the treatment outcomes were compared after one year. One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach. Data pertaining to demographics, clinical characteristics, radiological findings, and survey responses have been carefully collected prospectively.
- Being tested
- Arthroscopic meniscus repair
- Keywords
- meniscal tear, meniscal repair, fibrin clot, augmentation, arthroscopy, knee, young patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic meniscus repairProcedure or surgery
Also called Arthroscopic meniscus repair with fibrin clot augmentation
A traditional two-portal arthroscopic approach is utilized. The meniscal edges are examined using a probe, and any meniscal tears that are not stable are evaluated for potential repair. For meniscus repair, sutures have been made using the "all-inside" or "outside-inside" and "inside-outside" techniques.
If the procedure involving the addition of a fibrin clot is being carried out, a volume of approximately 60 milliliters of blood is taken and thereafter transferred into a basin. An assistant is able to stir the blood using a glass syringe for approximately fifteen minutes to ensure sufficient coagulation surrounding the syringe. After a sufficient clot has developed at the end of the syringe, a grasper is used to insert the clot through the anterolateral arthroscopy portal. The meniscal sutures are intentionally loosened to accommodate the clot in the meniscus, ensuring optimal contact with the lesion. Subsequently, the sutures are fastened and knotted.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I of patients | Other | Individuals who undergo the conventional arthroscopic meniscus repair procedure Receives: Procedure: Arthroscopic meniscus repair |
| Cohort II of patients | Other | Patients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation. Receives: Procedure: Arthroscopic meniscus repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.
Pedi-IKDC is used to measure knee-related symptoms, function, and sports activity among children. The questionnaire consists of 13 items, each of which is scored using one of three rating systems: a range of 0 to 10 for items 2, 3, 12, and 13, a range of 0 to 4 for items 1, 4, 5, 6, 9, and 10, and a range of 0 to 1 for items 7 and 8. The 11th item consists of nine subquestions, each of which can be scored from 0 to 4. The overall score value is calculated by adding only the responses to 12 items and dividing the total by 92 (the highest number of points attainable). The score runs from 0 (worst case scenario) to 100 (best case scenario). The Pedi-IKDC has been proven to be a valid, trustworthy, and responsive questionnaire in a paediatric population with varied knee disorders, especially ligament and meniscal injuries, joint instability, and other disorders
Measured: before treatment, after 12 months and 24 months following treatment
Lysholm knee scale
Lysholm knee scoring scale has been proven to be suitable for a variety of knee pathologies and also for the adolescent population. The scale comprises eight items. Higher values of the score indicate better functioning of the knee. (range from 0 to 100).
Measured: before treatment, after 12 months and 24 months following treatment
Health-related paediatric quality of life (PedsQL)
PedsQL is a generic score, which estimates the quality of life of paediatric patients. The questionnaire consists of four domains with 23 questions: the general physical functioning, emotional, social, and functioning at school domains
Measured: before treatment, after 12 months and 24 months following treatment
Secondary outcomes (3)
Clinical evaluation at 12 and 24 months postoperatively. The clinical assessment involves evaluating of pain, swelling and estimating and comparing the range of motion of the knee with the contralateral side.
All patients are evaluated
Measured: 12 and 24 months postoperatively.
magnetic resonance imaging (MRI scan) of the knee
1.5T MRI system. Four main diagnostic sequences were analyzed, including sagittal proton density fast spin echo (PD FS-Sag), sagittal T2-weighted fast spin echo (T2W-Sag), coronal proton density fast spin echo with fat saturation (PD FS-Cor), and coronal T2-weighted fast spin echo with fat saturation (T2W-Cor). Signal changes on MRI are graded using Stoller and Crues' 3-stage classification. Grade 0 was defined as a normal meniscus; the meniscus demonstrates low signal intensity in the images. Grade 1 is described as an intrameniscal signal with irregular margins that do not connect or communicate with an articular surface. Grade 2 is defined as a linear signal that does not abut or communicate with an articular surface. A linear or complex signal intensity that abuttes or communicates with an articular surface is classified as Grade 3. In summary, grade 3 is deemed unhealed, grade 2 as partially healed, and grade 1 as fully healed due to MRI assessment.
Measured: before treatment, after 12 months and 24 months following treatment
Revision rates (secondary arthroscopies)
secondary arthroscopies (revision) at 12 and 24 month following primary surgery
Measured: 12 and 24 month following primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start26 May 2021
- Primary completion26 Sep 2025 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus Tear Caused by a Traumatic EventStudies 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
- Model description
- Patients have been randomly assigned into two groups using computerised "randomizer for clinical trial lite". One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Responsible party
- Principal investigator, Viktorija Brogaite, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176183
- Sponsor's protocol ID
- 2021/5-1353-825
- Status last verified
- Aug 2025
- First submitted
- 10 Dec 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per the study protocol, the IPD has no intention of disclosing the information to third parties or other researchers. In accordance with the data analysis and verification process, the main author of the research could be requested for the provision of anonymized data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Prospective Study of Meniscal Repair Methods in Young Patients With Traumatic Meniscal Tears.
- ClinicalTrials.gov ID
- NCT06176183
- Acronym / sponsor ID
- 2021/5-1353-825
- Keywords
- meniscal tear, meniscal repair, fibrin clot, augmentation, arthroscopy, knee, young patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Study start
- 26 May 2021 (actual)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 19 Dec 2023 (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.
Performing arthroscopic meniscus repair following a traumatic meniscus tear as an alternative to a meniscectomy is now an acceptable choice. Preserving meniscus tissues is crucial due to the significant role they play as an essential part of the knee joint. It is essential to comprehend the additional tools that can impact the recovery of the meniscus after suturing. Patients have been randomly assigned into two groups using the computer "www.randomiser.org," and the treatment outcomes were compared after one year. One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach. Data pertaining to demographics, clinical characteristics, radiological findings, and survey responses have been carefully collected prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients have been randomly assigned into two groups using computerised "randomizer for clinical trial lite". One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach
| Arm | Type | Receives |
|---|---|---|
| Cohort I of patients | Other | Procedure: Arthroscopic meniscus repairIndividuals who undergo the conventional arthroscopic meniscus repair procedure |
| Cohort II of patients | Other | Procedure: Arthroscopic meniscus repairPatients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation. |
Who may qualify
- Ages
- 0 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Individuals who provide consent to participate in the study, including patients and their care providers. The inclusion criteria for this study are as follows: being under the age of 19, having a traumatic isolated full-thickness meniscal tear longer than 1cm that has been confirmed by both preoperative MRI and arthroscopy, and not having undergone any previous surgery on the affected knee.
Key exclusion criteria (1 listed)
- This investigation excludes patients with developmental disabilities who are unable to read or interpret in their native language.
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 |
|---|---|---|
| Arthroscopic meniscus repairAlso: Arthroscopic meniscus repair with fibrin clot augmentationA traditional two-portal arthroscopic approach is utilized. The meniscal edges are examined using a probe, and any meniscal tears that are not stable are evaluated for potential repair. For meniscus repair, sutures have been made using the "all-inside" or "outside-inside" and "inside-outside" techniques. If the procedure involving the addition of a fibrin clot is being carried out, a volume of approximately 60 milliliters of blood is taken and thereafter transferred into a basin. An assistant is able to stir the blood using a glass syringe for approximately fifteen minutes to ensure sufficient coagulation surrounding the syringe. After a sufficient clot has developed at the end of the syringe, a grasper is used to insert the clot through the anterolateral arthroscopy portal. The meniscal sutures are intentionally loosened to accommodate the clot in the meniscus, ensuring optimal contact with the lesion. Subsequently, the sutures are fastened and knotted. | Procedure or surgery | Cohort I of patients, Cohort II of patients |
Primary outcome
Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.
Time frame: before treatment, after 12 months and 24 months following treatment
Pedi-IKDC is used to measure knee-related symptoms, function, and sports activity among children. The questionnaire consists of 13 items, each of which is scored using one of three rating systems: a range of 0 to 10 for items 2, 3, 12, and 13, a range of 0 to 4 for items 1, 4, 5, 6, 9, and 10, and a range of 0 to 1 for items 7 and 8. The 11th item consists of nine subquestions, each of which can be scored from 0 to 4. The overall score value is calculated by adding only the responses to 12 items and dividing the total by 92 (the highest number of points attainable). The score runs from 0 (worst case scenario) to 100 (best case scenario). The Pedi-IKDC has been proven to be a valid, trustworthy, and responsive questionnaire in a paediatric population with varied knee disorders, especially ligament and meniscal injuries, joint instability, and other disorders
Lysholm knee scale
Time frame: before treatment, after 12 months and 24 months following treatment
Lysholm knee scoring scale has been proven to be suitable for a variety of knee pathologies and also for the adolescent population. The scale comprises eight items. Higher values of the score indicate better functioning of the knee. (range from 0 to 100).
Health-related paediatric quality of life (PedsQL)
Time frame: before treatment, after 12 months and 24 months following treatment
PedsQL is a generic score, which estimates the quality of life of paediatric patients. The questionnaire consists of four domains with 23 questions: the general physical functioning, emotional, social, and functioning at school domains
3 secondary outcomes
Clinical evaluation at 12 and 24 months postoperatively. The clinical assessment involves evaluating of pain, swelling and estimating and comparing the range of motion of the knee with the contralateral side.
Time frame: 12 and 24 months postoperatively.
magnetic resonance imaging (MRI scan) of the knee
Time frame: before treatment, after 12 months and 24 months following treatment
Revision rates (secondary arthroscopies)
Time frame: 12 and 24 month following primary surgery
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 28 Aug 2025.
- Individual participant dataSharing planned: No. As per the study protocol, the IPD has no intention of disclosing the information to third parties or other researchers. In accordance with the data analysis and verification process, the main author of the research could be requested for the provision of anonymized data.
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.
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic meniscus repair in people with Meniscus Tear Caused by a Traumatic Event and Fibrin Clot Augmentation, run by Vilnius University at 2 sites in Lithuania.
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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form. (time frame: before treatment, after 12 months and 24 months following 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 28 Aug 2025.