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临床试验/NCT06002308
NCT06002308已完成不适用

Influence of Injury to the Kaplan Fibers and Anterolateral Ligament on Anterolateral Rotatory Knee Laxity in Adult and Pediatric Patients With Anterior Cruciate Ligament Injury: A Retrospective Cohort Study

Sichuan Province Orthopetic Hospital1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
540
试验地点
1
主要终点
Lateral meniscus

研究概览

简要总结

The goal of this [type of study: observational study] is to [detect concomitant KF and ALL injury in knees with ACL injury using MRI in both adult and pediatric patients and compare the effect of KF injury and multiple risk factors (concomitant injury to the ALL, medial collateral ligament [MCL], or anterior, central, or posterior part of the medial or lateral meniscus) on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.].

The main question [s] it aims to answer are:

[Does the main risk factor for a high-grade pivot shift after acute ACL injury differ between pediatric patients and adults?] [Does Concomitant KF injury significantly affect the pivot-shift phenomenon in pediatric patients with acute ACL injury?] Researchers will compare [71 pediatric patients and 469 adults] to see if [main risk factor for a high-grade pivot shift after acute ACL injury differs between pediatric patients and adults?].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral acute primary ACL tear, considered when the patient reported knee injury occurring less than 2 weeks before the examination;
  • bone bruising on the femoral condyles and tibial plateau identified on MRI.

排除标准

  • concomitant ligament (posterior cruciate ligament and/or posterolateral complex) procedures or realignment procedures; contralateral knee injury;
  • previous injury or surgery affecting the ipsilateral knee;
  • insufficient data from the electronic medical record system;
  • lack of KF visualization on MRI.

结局指标

主要结局

Lateral meniscus

时间窗: 3 years

concomitant anterior, central, or posterior part of lateral meniscus injury or not

ALL injury

时间窗: 3 years

concomitant ALL injury or not

MCL injury

时间窗: 3 years

concomitant MCL injury or not

KF injury

时间窗: 3 years

concomitant KF injury or not

Medial meniscus injury

时间窗: 3 years

concomitant anterior, central, or posterior part of medial meniscus injury or not

次要结局

未报告次要终点

研究者

发起方
Sichuan Province Orthopetic Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiaming Cui

Attending Doctor

Sichuan Province Orthopetic Hospital

研究点 (1)

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