跳至主要内容
临床试验/NCT06906783
NCT06906783招募中不适用

Comparison of Transtibial Pull Out Method And Suture Anchor Method in Surgical Treatment of Meniscus Extrusion

Ataturk University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
1
主要终点
Change in the amount of meniscus extrusion in MR images.

研究概览

简要总结

The concept of meniscal extrusion has recently been recognized as an important pathological condition associated with meniscal dysfunction. Meniscal extrusion is the medial or lateral displacement of the meniscus beyond the edges of the tibial plateau. Some meniscal extrusions are physiologic, but large degrees of extrusion are thought to be pathologic.

Meniscal extrusion can vary in extent from minimal physiological extrusion to extrusions exceeding 10 mm. The generally accepted threshold value is considered to be 3 mm.

To date, the gold standard for measuring meniscal extrusion is T2-weighted MRI. MRI is valuable not only due to its ability to define other meniscal or knee pathologies but also because it provides good sensitivity and specificity.

Surgical treatment of meniscal extrusion is preferred in young, active, symptomatic patients and individuals with acute injuries. The treatment approach may vary depending on the underlying cause. One of these methods is centralization surgery, which aims to achieve the anatomical reduction of the extruded meniscus.

The aim of this study is to compare the functional outcomes of transtibial pull-out and suture anchor techniques used in centralization surgery and to contribute to standardization.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presence of meniscal extrusion greater than 3 mm on MRI scans
  • •Symptomatic complaints in the knee with extrusion

排除标准

  • •Malalignment greater than 5 degrees
  • •Presence of Kellgren-Lawrence grade 3-4 osteoarthritis

研究组 & 干预措施

Transtibial Pull Out Method

Active Comparator

干预措施: Transtibial Pull Out Method (Procedure)

Suture Anchor Method

Active Comparator

干预措施: Suture Anchor Method (Procedure)

结局指标

主要结局

Change in the amount of meniscus extrusion in MR images.

时间窗: From enrollment to the end of treatment at 12 months

determine the change in the amount of meniscus extrusion in preoperative and postoperative 12th month MR images.

次要结局

  • Lysholm score(From enrollment to the end of treatment at 3, 6 and 12 months.)
  • Tegner activity score(From enrollment to the end of treatment at 3, 6 and 12 months.)
  • International Knee Documentation Committee (IKDC) Score(From enrollment to the end of treatment at 3, 6 and 12 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammet Celik

Principal Investigator

Ataturk University

研究点 (1)

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