A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods

NCT ID: NCT06176183

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2026-12-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort I of patients

Individuals who undergo the conventional arthroscopic meniscus repair procedure

Group Type: OTHER

Arthroscopic meniscus repair

Intervention Type: 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.

Cohort II of patients

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

Group Type: OTHER

Arthroscopic meniscus repair

Intervention Type: 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.

Interventions

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 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.

Intervention Type: PROCEDURE

Other Intervention Names

Arthroscopic meniscus repair with fibrin clot augmentation

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Viktorija Brogaite

Viktorija Brogaite Martinkeniene MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vilnius University, Medical faculty

Vilnius, , Lithuania

Site Status: RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Facility Contacts

Viktorija Brogaite Martinkeniene, MD

Role: primary

viktorija.brogaite@mf.vu.lt

37069805546

Viktorija Brogaite Martinkeniene, MD

Role: primary

viktorija.brogaite@santa.lt

37069805546

Other Identifiers

2021/5-1353-825

Identifier Type: -

Identifier Source: org_study_id