Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541756
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears - A Prospectively Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FCAR
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 painRepairing 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
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 painRepairing 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None