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Anterior Cruciate Ligament InjuriesNCT05682820

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

An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Measurements on knee MRI performed during routine clinical practice
How many people
100 participants
Where
1 sitePoland
Study dates
3 Jun 2020to 31 Dec 2024
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 18 to 45 years
  • All sexes
  • Adult

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

Who may be able to join

  • Performed knee MRI with or without ACL tear

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Konrad Malinowski, MD PhD contact

+48 509812212

malwin8@wp.pl

Poland1 site, 1 recruiting

  • Artromedical Orthopaedic Clinic

    Bełchatów, Łódź Voivodeship, 97-400

    Konrad Malinowski, MD PhD, +48 509 812 212, malwin8@wp.pl

    Recruiting

Other trials in Poland

About this study

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.

Read the 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
Being tested
Measurements on knee MRI performed during routine clinical practice
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.

  • 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.

Study groups in NCT05682820
Study groupRoleWhat they receive
Patients with ACL tearPatients with ACL tear- MRIs will be assessed
Receives: Diagnostic Test: Measurements on knee MRI performed during routine clinical practice
Patients without ACL tearPatients without ACL tear - MRIs will be assessed
Receives: Diagnostic Test: Measurements on knee MRI performed during routine clinical practice

What is being measured

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

  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

    Measured: At the time of MRI exam

Secondary outcomes (5)

  1. Distance from Blumensaat line to the deepest part of LFC-IF / TS

    Distance from Blumensaat line to the deepest part of LFC-IF / TS

    Measured: At the time of MRI exam

  2. Distance from Blumensaat line to the front border of LFC-IF / TS

    Distance from Blumensaat line to the front border of LFC-IF / TS

    Measured: At the time of MRI exam

  3. LFC-IF / TS length

    LFC-IF / TS length

    Measured: At the time of MRI exam

  4. LFC-IF / TS depth

    LFC-IF / TS depth

    Measured: At the time of MRI exam

  5. Presence of LFC-IF / TS

    Presence of LFC-IF / TS

    Measured: At the time of MRI exam

Timeline

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

  1. First posted12 Jan 2023
  2. Study start3 Jun 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682820
Sponsor's protocol ID
1-rad-ar-2023
Status last verified
Jan 2023
First submitted
4 Jan 2023
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 30317524

  • 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.

    PubMed 32037234

  • 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.

    PubMed 32974801

  • 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.

    PubMed 31899869

  • 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.

    PubMed 31917606

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.

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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 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 Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Konrad Malinowski, MD PhD (+48 509812212, malwin8@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance from Blumensaat line to the rear border of LFC-IF / TS (time frame: At the time of MRI exam). 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 NCT05682820, which also lists 5 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 12 Jan 2023.

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