NCT06707285

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

November 24, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

ACL ,femoral notch

Outcome Measures

Primary Outcomes (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

    Base line

Study Arms (1)

ACL injured group , non-injured group

Device: MRI

Interventions

MRIDEVICE

1.5T siemens

ACL injured group , non-injured group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 32150091BACKGROUND
  • 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.

    PMID: 34710345BACKGROUND
  • 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.

    PMID: 36700274BACKGROUND
  • 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.

    PMID: 35019732BACKGROUND
  • 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.

    PMID: 37310177BACKGROUND
  • 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.

    PMID: 34236929BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

November 24, 2024

First Posted

November 27, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 27, 2024

Record last verified: 2024-11