Influence of Injury to the Kaplan Fibers in Adult and Pediatric Patients With ACL Injury

Completed

• Conditions: ACL-injury

• Registration Number: NCT06002308
• Lead Sponsor: Sichuan Province Orthopetic Hospital

Brief Summary

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 \[main risk factor for a high-grade pivot shift after acute ACL injury differs between pediatric patients and adults?\].

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Status Verified: 2023-08
• Study First Submitted: 2023-08-05
• Study First Submitted QC: 2023-08-12
• Last Update Submitted: 2023-08-12
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lateral meniscus	3 years	concomitant anterior, central, or posterior part of lateral meniscus injury or not
ALL injury	3 years	concomitant ALL injury or not
MCL injury	3 years	concomitant MCL injury or not
KF injury	3 years	concomitant KF injury or not
Medial meniscus injury	3 years	concomitant anterior, central, or posterior part of medial meniscus injury or not

Trial Locations

Locations (1)

Sichuan Provincial Orthopedic Hospital; 🇨🇳 Chengdu, Sichuan, China