A Comparative Prospective Study of the Arthroscopic Meniscus Repair Methods

Study Overview
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Brief Summary
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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 randomiser 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.

Official Title
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A Prospective Study Evaluating Different Arthroscopic Repair Methods for Youths With Traumatic Meniscus Injuries.

Conditions
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Meniscus Tear Caused by a Traumatic Event

Intervention / Treatment
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* Procedure: Arthroscopic meniscus repair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients have been randomly assigned into two groups using computerised randomiser 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


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscus tear, meniscus repair, knee, fibrin clot, arthroscopy