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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03622034
Other study ID # knee measures
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date December 1, 2019

Study information

Verified date August 2018
Source Assiut University
Contact Michael B. Mady, M.B.B.ch
Phone 01004880799
Email michael24792@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Changes in Knee Measurements Between Egyptian and Western Population

Intervention

Other:
posterior condylar offset measurement
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

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. — View Citation

Conley S, Rosenberg A, Crowninshield R. The female knee: anatomic variations. J Am Acad Orthop Surg. 2007;15 Suppl 1:S31-6. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measure posterior condylar offset in the Egyptian population 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