A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods

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.

Study Overview

• Status: Recruiting
• Conditions: Meniscus Tear Caused by a Traumatic Event; Fibrin Clot Augmentation; Meniscal Repair
• Intervention / Treatment: Procedure: Arthroscopic meniscus repair

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, LT-08661
    • Recruiting
    • Vilnius University Hospital Santaros Klinikos
    • Contact: Viktorija Brogaite Martinkeniene, MD; Phone Number: 37069805546; Email: viktorija.brogaite@santa.lt
  • Vilnius, Lithuania, LT-03101
    • Recruiting
    • Vilnius University, Medical faculty
    • Contact: Viktorija Brogaite Martinkeniene, MD; Phone Number: 37069805546; Email: viktorija.brogaite@mf.vu.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• This investigation excludes patients with developmental disabilities who are unable to read or interpret in their native language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort I of patients; Individuals who undergo the conventional arthroscopic meniscus repair procedure	Procedure: Arthroscopic meniscus repair; 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.; Other Names: Arthroscopic meniscus repair with fibrin clot augmentation
Other: Cohort II of patients; Patients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation.	Procedure: Arthroscopic meniscus repair; 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.; Other Names: Arthroscopic meniscus repair with fibrin clot augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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	before treatment, after 12 months and 24 months following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before treatment, after 12 months and 24 months following treatment
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	12 and 24 months postoperatively.
Revision rates (secondary arthroscopies)	secondary arthroscopies (revision) at 12 and 24 month following primary surgery	12 and 24 month following primary surgery

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Vilnius University Hospital Santaros Klinikos

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): September 26, 2025
• Study Completion (Estimated): December 26, 2026

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: knee; arthroscopy; augmentation; meniscal repair; fibrin clot; young patients; meniscal tear
• Other Study ID Numbers: 2021/5-1353-825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No