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A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods

V

Vilnius University

Status

Enrolling

Conditions

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

Treatments

Procedure: Arthroscopic meniscus repair

Study type

Interventional

Funder types

Other

Identifiers

NCT06176183
2021/5-1353-825

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 19 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Cohort I of patients
Other group
Description:
Individuals who undergo the conventional arthroscopic meniscus repair procedure
Treatment:
Procedure: Arthroscopic meniscus repair
Cohort II of patients
Other group
Description:
Patients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation.
Treatment:
Procedure: Arthroscopic meniscus repair

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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