Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAnkara City Hospital Bilkent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fibrine Clot-augmented Meniscal Repair
Procedure/SurgeryThe 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.
Conventional Meniscal Repair
Procedure/SurgeryPatients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Fibrin Clot-augmented groupExperimental treatment 1 intervention
Group B: Conventionally repaired groupActive comparator 1 intervention
Trial outcomes
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)
Time frame
Postoperative 1st yearSecondary outcomes
1
Tegner Activity Scale
minimum value:0, maximum value 10, higher values mean better outcome
Time frame
Postoperative 1.st year2
The Knee injury and Osteoarthritis Outcome Score (KOOS)
minimum value:0, maximum value 100, higher values mean better outcome
Time frame
Postoperative 1.st year3
Tegner-Lysholm Score
minimum value:0, maximum value 100, higher values mean better outcome
Time frame
Postoperative 1.st yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ankara City Hospital Bilkent
Lead sponsor
Ankara Etlik City Hospital
Collaborator
Source ClinicalTrials.gov