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CompletedNCT06002308Updated Aug 21, 2023

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

An observational study in ACL-injury, sponsored by Sichuan Province Orthopetic Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Sichuan Province Orthopetic Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
540
Sex
All
01

Study 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?].

02

Conditions studied

  • ACL-injury

Keywords

  • Rotatory instability
  • Kaplan fiber injury
  • Anterolateral ligament
  • Meniscal injury
  • Magnetic resonance imaging
  • Anterior cruciate ligament
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 540 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

This is the only study on the registry with Sichuan Province Orthopetic Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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).

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
540 participants (actual)
Patient registry
No

Interventions

  • OtherAge

    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.

06

What researchers measure

Primary outcomes

  1. KF injury

    concomitant KF injury or not

    Time frame: 3 years

  2. ALL injury

    concomitant ALL injury or not

    Time frame: 3 years

  3. MCL injury

    concomitant MCL injury or not

    Time frame: 3 years

  4. Medial meniscus injury

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

    Time frame: 3 years

  5. Lateral meniscus

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

    Time frame: 3 years

07

Study locations

1 site
  • Sichuan Provincial Orthopedic Hospital
    Chengdu, Sichuan 610000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06002308
Lead sponsor
Sichuan Province Orthopetic Hospital
Responsible party
Jiaming Cui (Attending Doctor, Sichuan Province Orthopetic Hospital) — Principal investigator
First posted
Aug 21, 2023
Start date
Jun 20, 2023
Primary completion
Jun 22, 2023
Completion
Jun 22, 2023
Last update
Aug 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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