A Comparative Prospective Study of the Arthroscopic Meniscus Repair Methods

Not Applicable

Recruiting

• Conditions: Meniscus Tear Caused by a Traumatic Event
• Interventions: Procedure: Arthroscopic meniscus repair

• Registration Number: NCT06176183
• Lead Sponsor: Vilnius University

Brief 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. 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 computerised application "randomizer for clinical trial lite," 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-26
• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-10
• Study First Posted: 2023-12-19
• Last Update Submitted: 2024-01-01
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-05-26
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort II of patients	Arthroscopic meniscus repair	Patients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation.
Cohort I of patients	Arthroscopic meniscus repair	Individuals who undergo the conventional arthroscopic meniscus repair procedure

Primary Outcome Measures

Name	Time	Method
Health-related paediatric quality of life (PedsQL)	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
Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.	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	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).
magnetic resonance imaging (MRI scan) of the knee	before treatment, after 12 months and 24 months following treatment	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.

Trial Locations

Locations (2)

Vilnius University, Medical faculty; 🇱🇹 Vilnius, Lithuania

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania