Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears

NCT06541756 | Recruiting

• 1 other identifier: E2-24-7900
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with a healed meniscus on MRI

  Meniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial)

  Postoperative 1st year

Secondary Outcomes (3)

• Tegner Activity Scale

  Postoperative 1.st year

• The Knee injury and Osteoarthritis Outcome Score (KOOS)

  Postoperative 1.st year

• Tegner-Lysholm Score

  Postoperative 1.st year

Study Arms (2)

Fibrin Clot-augmented group

EXPERIMENTAL

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.

Procedure: Fibrine Clot-augmented Meniscal Repair

Conventionally repaired group

ACTIVE COMPARATOR

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.

Procedure: Conventional Meniscal Repair

Interventions

Fibrine Clot-augmented Meniscal Repair PROCEDURE

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.

Fibrin Clot-augmented group

Conventional Meniscal Repair PROCEDURE

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

Conventionally repaired group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• Ankara Etlik City Hospital: collaborator

Study Sites (2)

Ankara Bilkent City Hospital

Ankara, 06000, Turkey (Türkiye)

RECRUITING

Ankara Etlik City Hospital

Ankara, 06000, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Keller RE, O'Donnell EA, Medina GIS, Linderman SE, Cheng TTW, Sabbag OD, Oh LS. Biological augmentation of meniscal repair: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):1915-1926. doi: 10.1007/s00167-021-06849-5. Epub 2022 Mar 8.

  PMID: 35258647 BACKGROUND

• Chrysanthou C, Laliotis N, Paraskevas GK, Anastasopoulos N, Packer G. Enhancing Meniscal Repair: Investigating the Impact of an Exogenous Fibrin Clot. Cureus. 2024 Jan 27;16(1):e53083. doi: 10.7759/cureus.53083. eCollection 2024 Jan.

  PMID: 38288322 BACKGROUND

• Rodriguez AN, Reist H, Liechti DJ, Geeslin AG, LaPrade RF. Shuttling Technique for Directed Fibrin Clot Placement During Augmented Inside-Out Repair of Horizontal Meniscus Tears. Arthrosc Tech. 2022 Nov 17;11(12):e2205-e2211. doi: 10.1016/j.eats.2022.08.027. eCollection 2022 Dec.

  PMID: 36632380 BACKGROUND

• Kinoshita T, Hashimoto Y, Orita K, Iida K, Takahashi S, Nakamura H. Bone Marrow-Derived Fibrin Clots Stimulate Healing of a Knee Meniscal Defect in a Rabbit Model. Arthroscopy. 2023 Jul;39(7):1662-1670. doi: 10.1016/j.arthro.2022.12.013. Epub 2022 Dec 24.

  PMID: 36574822 BACKGROUND

• Kale S, Deore S, Gunjotikar A, Singh S, Ghodke R, Agrawal P. Arthroscopic meniscus repair and augmentation with autologous fibrin clot in Indian population: A 2-year prospective study. J Clin Orthop Trauma. 2022 Aug 6;32:101969. doi: 10.1016/j.jcot.2022.101969. eCollection 2022 Sep.

  PMID: 36035781 BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Enejd Veizi, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enejd Veizi, MD

CONTACT

+905439799959; dr.nad89@hotmail.com

Yasin Erdoğan, MD

CONTACT

+905056056097; yasin-erdgn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: not possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective Randomized Controlled Study

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)