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

August 12, 2023 updated by: Jiaming Cui, Sichuan Province Orthopetic Hospital

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

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?].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Sichuan Provincial Orthopedic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

1994 patients were identified from medical records between Jan. 2019 and Dec. 2021. After reviewing the inclusion and exclusion criteria, 540 patients were included in the present study (71 pediatric patients and 469 adults).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KF injury
Time Frame: 3 years
concomitant KF injury or not
3 years
ALL injury
Time Frame: 3 years
concomitant ALL injury or not
3 years
MCL injury
Time Frame: 3 years
concomitant MCL injury or not
3 years
Medial meniscus injury
Time Frame: 3 years
concomitant anterior, central, or posterior part of medial meniscus injury or not
3 years
Lateral meniscus
Time Frame: 3 years
concomitant anterior, central, or posterior part of lateral meniscus injury or not
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Province Orthopetic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Actual)

June 22, 2023

Study Completion (Actual)

June 22, 2023

Study Registration Dates

First Submitted

August 5, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-018-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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