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ACL InjuryNCT06707285

MRI Morphology of Femoral Notch in ACL Injury

An observational study of ACL Injury, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study aims to investigate the association between femoral notch morphology, as assessed by MRI, and the risk of ACL injury Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
ACL Injury
What is being tested?
MRI
Type of treatment
Medical device
How many people
72 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 1 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Study population will include adult patients with ACL injury that had previous knee MRI imaging with no history of previous knee surgery or any pathological condition affecting bone health.

Who may be able to join

  • patient aged 18-50 years.
  • diagnosed with an ACL injury and confirmed by MRI and age-matched controls.

Who cannot join

  • age <18 yo and >50 years
  • patients with previous knee surgeries
  • congenital knee deformities
  • systemic conditions affecting bone health

About this study

Official title: MRI Imaging Assessment of Femoral Notch Morphology in Patients With ACL Injury

This study aims to investigate the association between femoral notch morphology, as assessed by MRI, and the risk of ACL injury

Conditions
ACL Injury
Being tested
MRI
Keywords
ACL ,femoral notch
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.

  • MRIDevice

    1.5T siemens

Study groups in NCT06707285
Study groupRoleWhat they receive
ACL injured group , non-injured groupNot described
Receives: Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between femoral notch morphology and incidence of ACL injury

    Identify the different types of femoral notch angle , shapes and calculate the notch width index and correlate these differences with the incidence of ACL injury

    Measured: Base line

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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
Case-control
Time perspective
Retrospective
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06707285
Sponsor's protocol ID
MRI in ACL injury
Status last verified
Nov 2024
First submitted
24 Nov 2024
Last updated
27 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang M, Li Y, Li H, Liao C, Xu H, Luo X. Predictive effects of the intercondylar notch morphology on anterior cruciate ligament injury in males: A magnetic resonance imaging analysis. Medicine (Baltimore). 2020 Mar;99(10):e19411. doi: 10.1097/MD.0000000000019411.

    PubMed 32150091

  • Micicoi G, Jacquet C, Khakha R, LiArno S, Faizan A, Seil R, Kocaoglu B, Cerciello S, Martz P, Ollivier M. Femoral and Tibial Bony Risk Factors for Anterior Cruciate Ligament Injuries Are Present in More Than 50% of Healthy Individuals. Am J Sports Med. 2021 Dec;49(14):3816-3824. doi: 10.1177/03635465211050421. Epub 2021 Oct 28.

    PubMed 34710345

  • Gultekin MZ, Dincel YM, Keskin Z, Arslan S, Yildirim A. Morphometric risk factors effects on anterior cruciate ligament injury. Jt Dis Relat Surg. 2023;34(1):130-137. doi: 10.52312/jdrs.2023.910. Epub 2022 Dec 27.

    PubMed 36700274

  • Misir A, Sayer G, Uzun E, Guney B, Guney A. Individual and Combined Anatomic Risk Factors for the Development of an Anterior Cruciate Ligament Rupture in Men: A Multiple Factor Analysis Case-Control Study. Am J Sports Med. 2022 Feb;50(2):433-440. doi: 10.1177/03635465211062594. Epub 2022 Jan 12.

    PubMed 35019732

  • Pradhan P, Kaushal SG, Kocher MS, Kiapour AM. Development of Anatomic Risk Factors for ACL Injuries: A Comparison Between ACL-Injured Knees and Matched Controls. Am J Sports Med. 2023 Jul;51(9):2267-2274. doi: 10.1177/03635465231177465. Epub 2023 Jun 13.

    PubMed 37310177

  • Barnum MS, Boyd ED, Vacek P, Slauterbeck JR, Beynnon BD. Association of Geometric Characteristics of Knee Anatomy (Alpha Angle and Intercondylar Notch Type) With Noncontact ACL Injury. Am J Sports Med. 2021 Aug;49(10):2624-2630. doi: 10.1177/03635465211023750. Epub 2021 Jul 8.

    PubMed 34236929

Questions about this trial

What is this clinical trial studying?

An observational study of ACL Injury, run by Assiut University.

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: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Correlation between femoral notch morphology and incidence of ACL injury (time frame: Base line). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06707285, which also lists 6 linked publications.

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 27 Nov 2024.

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