Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign

Analysis of Radiological Features of Lateral Femoral Impaction Fracture (LFC-IF) / Lateral Femoral Notch Sign will be performed on MRIs of consecutive patients after anterior cruciate ligament (ACL) injuries and without ACL injuries.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear
• Intervention / Treatment: Diagnostic test: Measurements on knee MRI performed during routine clinical practice

Detailed Description

Two independent measurers will twicely measure the radiological features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign on MRIs of consecutive patients after anterior cruciate ligament (ACL) injuries and without ACL injuries. In cases without ACL injuries, radiological features of terminal sulcus (TS), a native sulcus located on the lateral femoral condyle, will be measured. Intra- and inter-rater agreements will be calculated.

The following radiological features will be assessed/ measured:

1. Presence of LFC-IF/ TS
2. LFC-IF/ TS depth
3. LFC-IF/ TS length
4. Distance from Blumensaat line to the front border of LFC-IF / TS
5. Distance from Blumensaat line to the deepest part of LFC-IF / TS
6. Distance from Blumensaat line to the rear border of LFC-IF / TS

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Konrad Malinowski, MD PhD; Phone Number: +48 509812212; Email: malwin8@wp.pl

Study Locations

• Poland
  • Łódzkie
    • Bełchatów, Łódzkie, Poland, 97-400
      • Recruiting
      • Artromedical Orthopaedic Clinic
      • Contact: Konrad Malinowski, MD PhD; Phone Number: +48 509 812 212; Email: malwin8@wp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with knee MRI with or without ACL tear, aged 18-45 years old, all sexes, with eligibility criteria.

Description

Inclusion Criteria:

• Performed knee MRI with or without ACL tear

Exclusion Criteria:

• Osteophytes hindering assessment of LFC-IF/ TS morphology
• Morphological disturbances hindering assessment of LFC-IF/ TS morphology

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with ACL tear; Patients with ACL tear- MRIs will be assessed	Diagnostic test: Measurements on knee MRI performed during routine clinical practice; Patients after knee injury are often advised to undergo knee MRI for diagnosis. Measurements on knee MRI performed during routine clinical practice will be made.
Patients without ACL tear; Patients without ACL tear - MRIs will be assessed	Diagnostic test: Measurements on knee MRI performed during routine clinical practice; Patients after knee injury are often advised to undergo knee MRI for diagnosis. Measurements on knee MRI performed during routine clinical practice will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance from Blumensaat line to the rear border of LFC-IF / TS	Distance from Blumensaat line to the rear border of LFC-IF /TS	At the time of MRI exam

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance from Blumensaat line to the deepest part of LFC-IF / TS	Distance from Blumensaat line to the deepest part of LFC-IF / TS	At the time of MRI exam
Distance from Blumensaat line to the front border of LFC-IF / TS	Distance from Blumensaat line to the front border of LFC-IF / TS	At the time of MRI exam
LFC-IF / TS length	LFC-IF / TS length	At the time of MRI exam
LFC-IF / TS depth	LFC-IF / TS depth	At the time of MRI exam
Presence of LFC-IF / TS	Presence of LFC-IF / TS	At the time of MRI exam

Collaborators and Investigators

• Sponsor: Artromedical Konrad Malinowski Clinic

Publications and helpful links

General Publications

• Lodewijks PCAM, Delawi D, Bollen TL, Dijkhuis GR, Wolterbeek N, Zijl JAC. The lateral femoral notch sign: a reliable diagnostic measurement in acute anterior cruciate ligament injury. Knee Surg Sports Traumatol Arthrosc. 2019 Feb;27(2):659-664. doi: 10.1007/s00167-018-5214-x. Epub 2018 Oct 13.
• Wierer G, Simetinger T, Hudelmaier M, Moroder P, Hoffelner T. Fate of the lateral femoral notch following early anterior cruciate ligament reconstruction. Knee. 2020 Mar;27(2):414-419. doi: 10.1016/j.knee.2020.01.009. Epub 2020 Feb 7.
• Dimitriou D, Reimond M, Foesel A, Baumgaertner B, Zou D, Tsai TY, Helmy N. The deep lateral femoral notch sign: a reliable diagnostic tool in identifying a concomitant anterior cruciate and anterolateral ligament injury. Knee Surg Sports Traumatol Arthrosc. 2021 Jun;29(6):1968-1976. doi: 10.1007/s00167-020-06278-w. Epub 2020 Sep 24.
• Bernholt DL, DePhillipo NN, Grantham WJ, Crawford MD, Aman ZS, Kennedy MI, LaPrade RF. Morphologic Variants of Posterolateral Tibial Plateau Impaction Fractures in the Setting of Primary Anterior Cruciate Ligament Tear. Am J Sports Med. 2020 Feb;48(2):318-325. doi: 10.1177/0363546519893709. Epub 2020 Jan 3.
• Bernholt DL, DePhillipo NN, Crawford MD, Aman ZS, Grantham WJ, LaPrade RF. Incidence of Displaced Posterolateral Tibial Plateau and Lateral Femoral Condyle Impaction Fractures in the Setting of Primary Anterior Cruciate Ligament Tear. Am J Sports Med. 2020 Mar;48(3):545-553. doi: 10.1177/0363546519895239. Epub 2020 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 1-rad-ar-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No