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

NCT06002308 | Completed

• 1 other identifier: KY2023-018-01
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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

Conditions

ACL-injury

Keywords

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

Outcome Measures

Primary Outcomes (5)

• KF injury

  concomitant KF injury or not

  3 years

• ALL injury

  concomitant ALL injury or not

  3 years

• MCL injury

  concomitant MCL injury or not

  3 years

• Medial meniscus injury

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

  3 years

• Lateral meniscus

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

  3 years

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Province Orthopetic Hospital: lead

Study Sites (1)

Sichuan Provincial Orthopedic Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Aging

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 21, 2023
• Study Start: June 20, 2023
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

CN (1)