- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622034
Knee Posterior Femoral Condylar Offset and Tibial Slope of the Egyptian Population (knee)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
In 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.
Tibial 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.
Data 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Proper lateral knee x ray of adult cases
Exclusion Criteria:
- 1. Improper x ray projection
- 2. Retained hardware
- 3. Malunited distal or upper tibia fracture
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure posterior condylar offset in the Egyptian population
Time Frame: one year
|
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
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- knee measures
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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