NCT05682820

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 3, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

January 4, 2023

Last Update Submit

January 4, 2023

Conditions

Anterior Cruciate Ligament InjuriesAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    At the time of MRI exam

  • LFC-IF / TS length

    At the time of MRI exam

  • LFC-IF / TS depth

    At the time of MRI exam

  • Presence of LFC-IF / TS

    At the time of MRI exam

Study Arms (2)

Patients with ACL tear

Patients with ACL tear- MRIs will be assessed

Diagnostic Test: Measurements on knee MRI performed during routine clinical practice

Patients without ACL tear

Patients without ACL tear - MRIs will be assessed

Diagnostic Test: Measurements on knee MRI performed during routine clinical practice

Interventions

Measurements on knee MRI performed during routine clinical practiceDIAGNOSTIC_TEST

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 with ACL tearPatients without ACL tear

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Performed knee MRI with or without ACL tear

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 30317524RESULT

  • 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.

    PMID: 32037234RESULT

  • 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.

    PMID: 32974801RESULT

  • 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.

    PMID: 31899869RESULT

  • 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.

    PMID: 31917606RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Konrad Malinowski, MD PhD

    Artromedical Orthopaedic Clinic, Bełchatów, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Malinowski, MD PhD

CONTACT

+48 509812212malwin8@wp.pl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Clinic

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 12, 2023

Study Start

June 3, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

PL(1)