Clinical trial NCT06176183: A Comparative Prospective Study of the Arthroscopic Meniscus Repair Methods
Official title: A Prospective Study Evaluating Different Arthroscopic Repair Methods for Youths With Traumatic Meniscus Injuries.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Tear Caused by a Traumatic Event
Keywords: meniscus tear, meniscus repair, knee, fibrin clot, arthroscopy
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Vilnius University Hospital Santaros Klinikos
First posted: 2023-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.
timeFrame: before treatment, after 12 months and 24 months following treatment
measure: Lysholm knee scale
timeFrame: before treatment, after 12 months and 24 months following treatment
measure: Health-related paediatric quality of life (PedsQL)
timeFrame: before treatment, after 12 months and 24 months following treatment
measure: magnetic resonance imaging (MRI scan) of the knee
timeFrame: before treatment, after 12 months and 24 months following treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University, Medical faculty
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
Study officials:
References: