Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05682820
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2023-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance from Blumensaat line to the rear border of LFC-IF / TS', 'timeFrame': 'At the time of MRI exam', 'description': 'Distance from Blumensaat line to the rear border of LFC-IF /TS'}], 'secondaryOutcomes': [{'measure': 'Distance from Blumensaat line to the deepest part of LFC-IF / TS', 'timeFrame': 'At the time of MRI exam', 'description': 'Distance from Blumensaat line to the deepest part of LFC-IF / TS'}, {'measure': 'Distance from Blumensaat line to the front border of LFC-IF / TS', 'timeFrame': 'At the time of MRI exam', 'description': 'Distance from Blumensaat line to the front border of LFC-IF / TS'}, {'measure': 'LFC-IF / TS length', 'timeFrame': 'At the time of MRI exam', 'description': 'LFC-IF / TS length'}, {'measure': 'LFC-IF / TS depth', 'timeFrame': 'At the time of MRI exam', 'description': 'LFC-IF / TS depth'}, {'measure': 'Presence of LFC-IF / TS', 'timeFrame': 'At the time of MRI exam', 'description': 'Presence of LFC-IF / TS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries', 'Anterior Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Tear']}, 'referencesModule': {'references': [{'pmid': '30317524', 'type': 'RESULT', '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.'}, {'pmid': '32037234', 'type': 'RESULT', '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.'}, {'pmid': '32974801', 'type': 'RESULT', '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.'}, {'pmid': '31899869', 'type': 'RESULT', '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.'}, {'pmid': '31917606', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe following radiological features will be assessed/ measured:\n\n1. Presence of LFC-IF/ TS\n2. LFC-IF/ TS depth\n3. LFC-IF/ TS length\n4. Distance from Blumensaat line to the front border of LFC-IF / TS\n5. Distance from Blumensaat line to the deepest part of LFC-IF / TS\n6. Distance from Blumensaat line to the rear border of LFC-IF / TS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with knee MRI with or without ACL tear, aged 18-45 years old, all sexes, with eligibility criteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performed knee MRI with or without ACL tear\n\nExclusion Criteria:\n\n* Osteophytes hindering assessment of LFC-IF/ TS morphology\n* Morphological disturbances hindering assessment of LFC-IF/ TS morphology'}, 'identificationModule': {'nctId': 'NCT05682820', 'briefTitle': 'Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign', 'organization': {'class': 'OTHER', 'fullName': 'Artromedical Konrad Malinowski Clinic'}, 'officialTitle': 'Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign', 'orgStudyIdInfo': {'id': '1-rad-ar-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ACL tear', 'description': 'Patients with ACL tear- MRIs will be assessed', 'interventionNames': ['Diagnostic Test: Measurements on knee MRI performed during routine clinical practice']}, {'label': 'Patients without ACL tear', 'description': 'Patients without ACL tear - MRIs will be assessed', 'interventionNames': ['Diagnostic Test: Measurements on knee MRI performed during routine clinical practice']}], 'interventions': [{'name': 'Measurements on knee MRI performed during routine clinical practice', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients with ACL tear', 'Patients without ACL tear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97-400', 'city': 'Bełchatów', 'state': 'Łódź Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Konrad Malinowski, MD PhD', 'role': 'CONTACT', 'email': 'malwin8@wp.pl', 'phone': '+48 509 812 212'}], 'facility': 'Artromedical Orthopaedic Clinic', 'geoPoint': {'lat': 51.36883, 'lon': 19.35671}}], 'centralContacts': [{'name': 'Konrad Malinowski, MD PhD', 'role': 'CONTACT', 'email': 'malwin8@wp.pl', 'phone': '+48 509812212'}], 'overallOfficials': [{'name': 'Konrad Malinowski, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Artromedical Orthopaedic Clinic, Bełchatów, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artromedical Konrad Malinowski Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Clinic', 'investigatorFullName': 'Konrad Malinowski MD', 'investigatorAffiliation': 'Artromedical Konrad Malinowski Clinic'}}}}