Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears (FCAR)

Ankara City Hospital

Status: Enrolling

Conditions: Knee Injuries; Fibrin Blood Clot; Meniscus Tear; Meniscus Lesion

Treatments: Procedure: Conventional Meniscal Repair; Procedure: Fibrine Clot-augmented Meniscal Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT06541756

E2-24-7900

Details and patient eligibility

About

Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes.

The displaced meniscal fragment can cause mechanical symptoms such as locking, clicking, or catching of the knee, as well as pain and swelling. If not properly treated, buckle-handle meniscal tears can lead to further complications, including chronic knee instability, increased risk of osteoarthritis, and persistent joint pain.Repairing a longitudinal meniscal tear offers several advantages over partial meniscectomy, particularly in preserving knee function and preventing long-term complications.

Meniscal repair aims to restore the integrity of the meniscus, which plays a crucial role in load distribution, shock absorption, and joint stability.

Utilizing a fibrin clot during the repair of a buckle-handle meniscal tear can enhance the healing process and improve surgical outcomes. Fibrin clots act as a biological scaffold, promoting tissue regeneration by providing a matrix that facilitates cellular migration and proliferation.

The purpose of this study was to compare longitudinal meniscal tear repair reinforced with fibrin clot with routine end-to-end repair in a prospective randomized controlled trial.

Full description

This study is designed as a prospective randomized controlled clinical trial. It aims to include patients presenting to the Orthopedics and Traumatology clinics at Ankara Bilkent and Etlik City Hospitals with longitudinal meniscus tears between August 2024 and December 2028. Participants will be randomly assigned to one of two groups: one receiving meniscus repair with fibrin clot reinforcement and the other receiving standard repair.

Patients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures, with spinal anesthesia. For the fibrin clot group, a fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. After completing the repairs, the surgical wounds and portals will be closed, and an elastic bandage will be applied. The post-operative rehabilitation protocols will be the same for all patients.

Patients will be clinically followed for at least one year, with healing rates compared using control magnetic resonance imaging at the end of the first year.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting with a painful meniscus (lateral or medial) longitudinal tear
• Being between the ages of 18 and 50
• Not having undergone surgery on the same knee before
• Having an MRI taken at the end of the 1st year post-surgery

Exclusion criteria

• Having additional collateral ligamentous damage along with the meniscus tear (such as MCL or LCL)
• Incomplete clinical scores at the end of the study
• A history of previous surgery on the same knee
• Having an active infection
• Not having a control MRI at the end of the 1st year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Fibrin Clot-augmented group

Experimental group

Description:

Patients in the experimental repair group will undergo routine meniscus repair surgery in addition to a fibrin clot placed within the ruptured sides using arthroscopic all-inside or inside-out sutures. The fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures.

Treatment:

Procedure: Fibrine Clot-augmented Meniscal Repair

Conventionally repaired group

Active Comparator group

Description:

Patients in the control repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures. The ruptured sides will be approximated as usual and the procedure will be considered completed.

Treatment:

Procedure: Conventional Meniscal Repair