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Completed

NCT Number: NCT06002308

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

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?].

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Key information

Conditions

ACL-injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Provincial Orthopedic Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

age

Other

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.

Primary outcomes

  1. KF injury

    Time frame: 3 years

    concomitant KF injury or not

  2. ALL injury

    Time frame: 3 years

    concomitant ALL injury or not

  3. MCL injury

    Time frame: 3 years

    concomitant MCL injury or not

  4. Medial meniscus injury

    Time frame: 3 years

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

  5. Lateral meniscus

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Sichuan Province Orthopetic Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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