Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears - A Prospectively Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Number of patients with a healed meniscus on MRI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
not possible
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of patients with a healed meniscus on MRI
时间窗: Postoperative 1st year
Meniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial)
次要结局
- Tegner-Lysholm Score(Postoperative 1.st year)
- The Knee injury and Osteoarthritis Outcome Score (KOOS)(Postoperative 1.st year)
- Tegner Activity Scale(Postoperative 1.st year)
研究者
Enejd Veizi, MD
Assistant Professor
Ankara City Hospital Bilkent