Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06541756

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

Led by Ankara City Hospital Bilkent · Updated on 2025-10-02

120

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

A

Ankara City Hospital Bilkent

Lead Sponsor

A

Ankara Etlik City Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a surgical approach for repairing longitudinal meniscal tears, which are injuries involving a displaced fragment of the meniscus that can cause knee locking, clicking, pain, and swelling. These tears mainly affect the medial meniscus and often follow traumatic knee injuries, especially in athletes. The study compares repair methods to see if adding a fibrin clot can improve healing and outcomes compared to standard meniscal repair. Participants will be randomly assigned to one of two groups: one group will have routine meniscal repair surgery using arthroscopic sutures, while the other group will receive the same repair plus a fibrin clot made from bone marrow aspirate applied between the torn meniscus edges. This clot acts as a biological scaffold to promote tissue healing. Surgeries are performed under spinal anesthesia, and patients will follow the same rehabilitation plan after surgery. Participants will be followed clinically for at least one year, including MRI scans to assess healing of the meniscus. Researchers will also evaluate knee function and activity using scores like the Tegner Activity Scale, KOOS, and Tegner-Lysholm Score at one year. The main outcome is the number of patients with healed menisci on MRI after one year. The study runs from mid-2024 to mid-2029 and is led by Ankara City Hospital Bilkent.

CONDITIONS

Brief Title

Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presenting with a painful meniscus (lateral or medial) longitudinal tear
  • Between the ages of 18 and 50
  • No previous surgery on the same knee
  • Willing to have an MRI at one year after surgery
Not Eligible

You will not qualify if you...

  • Having additional collateral ligament damage such as MCL or LCL alongside the meniscus tear
  • Incomplete clinical scores at the end of the study
  • History of previous surgery on the same knee
  • Having an active infection
  • Not having a control MRI at the end of the first year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo meniscus repair surgery, either with fibrin clot augmentation or standard repair, under spinal anesthesia. Surgical wounds and portals are closed and an elastic bandage is applied.

1 surgical visit

Post-operative Follow-up

Duration - At least 1 year

Participants follow the same postoperative rehabilitation protocol and are clinically followed for at least one year to monitor healing and recovery.

Multiple clinical follow-up visits during the year

Trial Site Locations

Total: 2 locations

1

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye), 06000

Actively Recruiting

2

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye), 06000

Actively Recruiting

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Research Team

E

Enejd Veizi, MD

Y

Yasin Erdoğan, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Shuttling Technique for Directed Fibrin Clot Placement During Augmented Inside-Out Repair of Horizontal Meniscus Tears.

Ariel N Rodriguez, Hailee Reist, Daniel J Liechti...

https://pubmed.ncbi.nlm.nih.gov/36632380

Arthroscopic meniscus repair and augmentation with autologous fibrin clot in Indian population: A 2-year prospective study.

Sachin Kale, Sandeep Deore, Aditya Gunjotikar...

https://pubmed.ncbi.nlm.nih.gov/36035781