ACL-injuryNCT06002308
Influence of Injury to the Kaplan Fibers in Adult and Pediatric Patients With ACL Injury
An observational study of ACL-injury, run by Sichuan Province Orthopetic Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ACL-injury
- What is being tested?
- Age
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 22 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Age
- Keywords
- Rotatory instability, Kaplan fiber injury, Anterolateral ligament, Meniscal injury, Magnetic resonance imaging, Anterior cruciate ligament
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
KF injury
concomitant KF injury or not
Measured: 3 years
ALL injury
concomitant ALL injury or not
Measured: 3 years
MCL injury
concomitant MCL injury or not
Measured: 3 years
Medial meniscus injury
concomitant anterior, central, or posterior part of medial meniscus injury or not
Measured: 3 years
Lateral meniscus
concomitant anterior, central, or posterior part of lateral meniscus injury or not
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start20 Jun 2023
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL-injuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Province Orthopetic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaming Cui, Sichuan Province Orthopetic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002308
- Sponsor's protocol ID
- KY2023-018-01
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06002308
- Acronym / sponsor ID
- KY2023-018-01
- Conditions
- ACL-injury
- Keywords
- Rotatory instability, Kaplan fiber injury, Anterolateral ligament, Meniscal injury, Magnetic resonance imaging, Anterior cruciate ligament
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Sichuan Province Orthopetic HospitalUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AgeThe 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. | Other | – |
Primary outcome
KF injury
Time frame: 3 years
concomitant KF injury or not
ALL injury
Time frame: 3 years
concomitant ALL injury or not
MCL injury
Time frame: 3 years
concomitant MCL injury or not
Medial meniscus injury
Time frame: 3 years
concomitant anterior, central, or posterior part of medial meniscus injury or not
Lateral meniscus
Time frame: 3 years
concomitant anterior, central, or posterior part of lateral meniscus injury or not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL-injury, run by Sichuan Province Orthopetic Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KF injury (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.