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

NCT ID: NCT06002308

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-20

Study Completion Date

2023-06-22

Brief Summary

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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

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Conditions

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ACL-injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Age

The retrospective study included 540 patients with primary ACL tears (71 pediatric patients and 469 adults) whose MRI examination and pivot-shift test were conducted within 14 days after injury. 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 on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Province Orthopetic Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiaming Cui

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sichuan Provincial Orthopedic Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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KY2023-018-01

Identifier Type: -

Identifier Source: org_study_id

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