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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682820
• Other study ID #: 1-rad-ar-2023
• Status: Recruiting
• Start date: June 3, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Artromedical Konrad Malinowski Clinic
• Contact: Konrad Malinowski, MD PhD
• Phone: +48 509812212
• Email: malwin8[@]wp.pl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture

Intervention

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.

Locations

Country	Name	City	State
Poland	Artromedical Orthopaedic Clinic	Belchatów	Lódzkie

Sponsors (1)

Lead Sponsor	Collaborator
Artromedical Konrad Malinowski Clinic

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. 202 — View 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 — View 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 Arthros — View 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: 10.10 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	LFC-IF / TS length	LFC-IF / TS length	At the time of MRI exam
Secondary	LFC-IF / TS depth	LFC-IF / TS depth	At the time of MRI exam
Secondary	Presence of LFC-IF / TS	Presence of LFC-IF / TS	At the time of MRI exam