Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-01 @ 2:43 PM
Study NCT ID:
NCT03622034
Status:
UNKNOWN
Last Update Posted:
2018-08-09
First Post:
2018-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Posterior Femoral Condylar Offset and Tibial Slope of the Egyptian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-04', 'studyFirstSubmitDate': '2018-07-28', 'studyFirstSubmitQcDate': '2018-08-04', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure posterior condylar offset in the Egyptian population', 'timeFrame': 'one year', 'description': 'posterior condylar offset will be measured in a sample of the egyptian people to get the mean measure of posterior condylar offset in the egyptian people'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee features', 'ethnic changes'], 'conditions': ['Changes in Knee Measurements Between Egyptian and Western Population']}, 'referencesModule': {'references': [{'pmid': '22720389', 'type': 'BACKGROUND', 'citation': 'Kwak DS, Tao QB, Todo M, Jeon I. Determination of representative dimension parameter values of Korean knee joints for knee joint implant design. Proc Inst Mech Eng H. 2012 May;226(5):368-76. doi: 10.1177/0954411912442025.'}, {'pmid': '21948324', 'type': 'BACKGROUND', 'citation': 'Mahfouz M, Abdel Fatah EE, Bowers LS, Scuderi G. Three-dimensional morphology of the knee reveals ethnic differences. Clin Orthop Relat Res. 2012 Jan;470(1):172-85. doi: 10.1007/s11999-011-2089-2.'}, {'pmid': '19669385', 'type': 'BACKGROUND', 'citation': 'Bellemans J, Carpentier K, Vandenneucker H, Vanlauwe J, Victor J. The John Insall Award: Both morphotype and gender influence the shape of the knee in patients undergoing TKA. Clin Orthop Relat Res. 2010 Jan;468(1):29-36. doi: 10.1007/s11999-009-1016-2. Epub 2009 Aug 8.'}, {'pmid': '17766787', 'type': 'BACKGROUND', 'citation': 'Conley S, Rosenberg A, Crowninshield R. The female knee: anatomic variations. J Am Acad Orthop Surg. 2007;15 Suppl 1:S31-6. doi: 10.5435/00124635-200700001-00009.'}, {'pmid': '464035', 'type': 'BACKGROUND', 'citation': 'DiBennardo R, Taylor JV. Sex assessment of the femur: a test of a new method. Am J Phys Anthropol. 1979 May;50(4):635-7. doi: 10.1002/ajpa.1330500415.'}, {'pmid': '20814773', 'type': 'BACKGROUND', 'citation': 'Leszko F, Hovinga KR, Lerner AL, Komistek RD, Mahfouz MR. In vivo normal knee kinematics: is ethnicity or gender an influencing factor? Clin Orthop Relat Res. 2011 Jan;469(1):95-106. doi: 10.1007/s11999-010-1517-z.'}, {'pmid': '37173701', 'type': 'DERIVED', 'citation': 'Abdelnasser MK, Abdelhameed MA, Bassem M, Adam MF, Bakr HM, Khalifa YE. Sexual dimorphism of the posterior condylar offset of the femur and the medial posterior slope of the tibia in non-arthritic knees of Egyptian adults: an MRI study. J Orthop Surg Res. 2023 May 12;18(1):353. doi: 10.1186/s13018-023-03833-2.'}, {'pmid': '34496904', 'type': 'DERIVED', 'citation': 'Abdelnasser MK, Khalifa AA, Bassem M, Abdelhameed MA, Adam MF, Bakr HM, Khalifa YE. Anthropometric measurements of non-arthritic knees in an Egyptian population: an MRI-based study. J Orthop Surg Res. 2021 Sep 8;16(1):552. doi: 10.1186/s13018-021-02708-8.'}]}, 'descriptionModule': {'briefSummary': 'this study is to compare the posterior condylar offset , posterior condylar offset ratio and tibial slope of Egyptian population with Asian and Western results.These results may be important to examine if contemporary total knee arthroplasty components match the anatomy of Egyptian populations or they are significantly different with the need of different prosthesis designs and geometrics.', 'detailedDescription': 'Lateral knee x rays will be collected from the registry system of Assiut University Hospital through Paxera pacs system . Posterior condylar offset, posterior condylar offset ratio and tibial slope will be measured from the x rays.\n\nIn the sagittal plane, the femoral long axis will be drawn with equal distance to the anterior-posterior edges of the femoral shaft. One line will be drawn parallel to the anterior femoral shaft cortex and another parallel to the posterior femoral shaft cortex. A third line will be drawn parallel to the posterior femoral shaft cortex line, but tangent to the most posterior femoral condyles to represent the posterior condylar tangent line. The anterior-posterior dimension of the distal femur is defined as the distance between the anterior femoral shaft cortex line and the posterior femoral condyle tangent line . The posterior femoral condyle offset (PCO) is determined as the distance between the posterior femoral shaft cortex line and the posterior femoral condyle line, that is noted as PCO .The posterior femoral condyle offset ratio (PCOR) is calculated as the ratio of the posterior femoral condyle offset and the anterior-posterior dimension of the distal femur, i.e., PCO/ACP.\n\nTibial slope will be measured as follows; the tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope.\n\nData of the cases will be collected as name, age and gender. The results will be collected and will be compared with those of Asian and Western results. These results may be important to examine if contemporary TKA components match the anatomy of Egyptian populations or they are significantly different with the need of different prosthesis designs and geometrics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all adult cases who have proper lateral knee x ray on the registery system of Assiut University Hospital , will be collected. These x rays will be used in this study as posterior condylar offset, posterior condylar offset ratio and tibial slope will be measured on these x rays', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proper lateral knee x ray of adult cases\n\nExclusion Criteria:\n\n* 1\\. Improper x ray projection\n* 2\\. Retained hardware\n* 3\\. Malunited distal or upper tibia fracture'}, 'identificationModule': {'nctId': 'NCT03622034', 'acronym': 'knee', 'briefTitle': 'Knee Posterior Femoral Condylar Offset and Tibial Slope of the Egyptian Population', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Knee Posterior Femoral Condylar Offset and Tibial Slope of the Egyptian Population', 'orgStudyIdInfo': {'id': 'knee measures'}}, 'armsInterventionsModule': {'interventions': [{'name': 'posterior condylar offset measurement', 'type': 'OTHER', 'otherNames': ['tibial slope measurement'], 'description': 'the tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B. Mady, M.B.B.ch', 'role': 'CONTACT', 'email': 'michael24792@yahoo.com', 'phone': '01004880799'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of orthopedics and trauma surgery', 'investigatorFullName': 'MBMady', 'investigatorAffiliation': 'Assiut University'}}}}