Clinical trial NCT05682820: Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign
Official title: Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Lead sponsor: Artromedical Konrad Malinowski Clinic
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Distance from Blumensaat line to the rear border of LFC-IF / TS
timeFrame: At the time of MRI exam
Secondary outcomes:
measure: Distance from Blumensaat line to the deepest part of LFC-IF / TS
timeFrame: At the time of MRI exam
measure: Distance from Blumensaat line to the front border of LFC-IF / TS
timeFrame: At the time of MRI exam
measure: LFC-IF / TS length
timeFrame: At the time of MRI exam
measure: LFC-IF / TS depth
timeFrame: At the time of MRI exam
measure: Presence of LFC-IF / TS
timeFrame: At the time of MRI exam
Other outcomes:
Locations:
city: Bełchatów
country: Poland
facility: Artromedical Orthopaedic Clinic
state: Łódzkie
Study officials:
affiliation: Artromedical Orthopaedic Clinic, Bełchatów, Poland
name: Konrad Malinowski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.