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Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears

Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears - A Prospectively Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06541756
Acronym
FCAR
Enrollment
120
Registered
2024-08-07
Start date
2024-07-25
Completion date
2029-07-31
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrin Blood Clot, Knee Injuries, Meniscus Lesion, Meniscus Tear

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREFibrine Clot-augmented Meniscal Repair

The 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.

PROCEDUREConventional Meniscal Repair

Patients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures.

Sponsors

Ankara Etlik City Hospital
CollaboratorOTHER_GOV
Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

not possible

Intervention model description

Prospective Randomized Controlled Study

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with a healed meniscus on MRIPostoperative 1st yearMeniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial)

Secondary

MeasureTime frameDescription
Tegner Activity ScalePostoperative 1.st yearminimum value:0, maximum value 10, higher values mean better outcome
The Knee injury and Osteoarthritis Outcome Score (KOOS)Postoperative 1.st yearminimum value:0, maximum value 100, higher values mean better outcome
Tegner-Lysholm ScorePostoperative 1.st yearminimum value:0, maximum value 100, higher values mean better outcome

Countries

Turkey (Türkiye)

Contacts

Primary ContactEnejd Veizi, MD
dr.nad89@hotmail.com+905439799959
Backup ContactYasin Erdoğan, MD
yasin-erdgn@hotmail.com+905056056097

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026