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

ACL-injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002308
• Other study ID #: KY2023-018-01
• Status: Completed
• Start date: June 20, 2023
• Est. completion date: June 22, 2023

Study information

• Verified date: August 2023
• Source: Sichuan Province Orthopetic Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 identi?ed 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.

Related Conditions & MeSH terms

• ACL-injury
• Anterior Cruciate Ligament Injuries
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Sichuan Provincial Orthopedic Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Province Orthopetic Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KF injury	concomitant KF injury or not	3 years
Primary	ALL injury	concomitant ALL injury or not	3 years
Primary	MCL injury	concomitant MCL injury or not	3 years
Primary	Medial meniscus injury	concomitant anterior, central, or posterior part of medial meniscus injury or not	3 years
Primary	Lateral meniscus	concomitant anterior, central, or posterior part of lateral meniscus injury or not	3 years