A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods

NCT06176183 | Recruiting

• 1 other identifier: 2021/5-1353-825
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Meniscus Tear Caused by a Traumatic Event; Fibrin Clot Augmentation; Meniscal Repair

Keywords

meniscal tear; meniscal repair; fibrin clot; augmentation; arthroscopy; knee; young patients

Outcome Measures

Primary Outcomes (3)

• 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 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.

  12 and 24 months postoperatively.

• magnetic resonance imaging (MRI scan) of the knee

  before treatment, after 12 months and 24 months following treatment

• Revision rates (secondary arthroscopies)

  12 and 24 month following primary surgery

Study Arms (2)

Cohort I of patients

OTHER

Individuals who undergo the conventional arthroscopic meniscus repair procedure

Procedure: Arthroscopic meniscus repair

Cohort II of patients

OTHER

Patients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation.

Procedure: Arthroscopic meniscus repair

Interventions

Arthroscopic meniscus repair PROCEDURE

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.

Also known as: Arthroscopic meniscus repair with fibrin clot augmentation

Cohort I of patients; Cohort II of patients

Eligibility Criteria

• Age: 0 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Vilnius University: lead
• Vilnius University Hospital Santaros Klinikos: collaborator

Study Sites (2)

Vilnius University, Medical faculty

Vilnius, LT-03101, Lithuania

RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08661, Lithuania

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Viktorija Brogaite Martinkeniene MD

Model Details: 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

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 19, 2023
• Study Start: May 26, 2021
• Primary Completion: September 26, 2025
• Study Completion (Estimated): December 26, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2)