A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthroscopic meniscus repair.
- Who it may be relevant to
- Registry conditions: Meniscus Tear Caused by a Traumatic Event, Fibrin Clot Augmentation, Meniscal Repair. Basic parameters: 0 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lithuania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Prospective Study of Meniscal Repair Methods in Young Patients With Traumatic Meniscal Tears.
Overview
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.
Interventions
- 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 i
Primary outcome measures
- Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form. [Time frame: before treatment, after 12 months and 24 months following treatment]
- Lysholm knee scale [Time frame: before treatment, after 12 months and 24 months following treatment]
- Health-related paediatric quality of life (PedsQL) [Time frame: before treatment, after 12 months and 24 months following treatment]
Secondary outcome measures (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. [Time frame: 12 and 24 months postoperatively.]
- magnetic resonance imaging (MRI scan) of the knee [Time frame: before treatment, after 12 months and 24 months following treatment]
- Revision rates (secondary arthroscopies) [Time frame: 12 and 24 month following primary surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Lithuania · 2 centers
- Vilnius University, Medical faculty — Vilnius
- Vilnius University Hospital Santaros Klinikos — Vilnius
Identifiers
NCT: NCT06176183 · 2021/5-1353-825