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临床试验/NCT06617559
NCT06617559招募中不适用

A Prospective Comparison of Clinical and Radiological Maturation Outcomes of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction

Muzaffer Agir1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年5月14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
发起方
入组人数
25
试验地点
1
主要终点
Stability of Knee

研究概览

简要总结

With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.

The aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Elite athletes
  • •Amateur athletes
  • •Anterior cruciate ligament injury

排除标准

  • •Revision surgery
  • •Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )
  • •> Grade-2 cartilage injury
  • •Having previously undergone surgery on the same knee
  • •< 18 years age

研究组 & 干预措施

All-inside Quadriceps Tendon Graft Group

Experimental

干预措施: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft (Procedure)

All-inside Hamstring Tendon Graft Group

Experimental

干预措施: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft (Procedure)

结局指标

主要结局

Stability of Knee

时间窗: 9 months

Pivot shift test

Autograft Maturation

时间窗: 12 months

Comparison of different autografts maturation on MRI images. The signal-to-noise quotient formula will be used to assess graft maturation. According to the method described by Chan and Yau, the difference between the signals of the ACL graft and the quadriceps tendon will be used to evaluate maturation by relating it to the background signal.

次要结局

  • Range of Motion(6 months)
  • Muscle Strength(9 months)

研究者

发起方
Muzaffer Agir
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muzaffer Agir

Medical Doctor

Acibadem University

研究点 (1)

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