Is Standard 3-degree of External Rotation for Posterior Femoral Cut Relevant for Turkish Population

Healthy Clinical Trial

Official title:

Is Standard 3-degree of External Rotation for Posterior Femoral Cut Relevant for Turkish Population: An Anthropometric MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355182
• Other study ID #: 3586
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: April 12, 2020

Study information

• Verified date: April 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the posterior condylar angle of the distal femur in Turkish population and its concordance with the current standard prosthesis designs used in total knee arthroplasty and to evaluate anthropometric features of the distal femur in the Turkish population.

Description:

The investigators would like to measure condylar twist angles(CTA), posterior condylar angles(PCA), femoral mediolateral lengths (fML), medial femoral anteroposterior lengths(fMAP), lateral femoral anteroposterior lengths (fLAP), distances between trochlear groove and fMAP(DBTG-fMAP), distances between trochlear groove and fLAP(DBTG-fLAP), medial and lateral posterior condylar cartilage thicknesses(MPCCT/LPCCT) on the Magnetic Resonance Images (MRI) of 240 knees of 120 Turkish subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 12, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• non-arthritic knees,

Exclusion Criteria: Patients with,

• intra- or extraarticular deformity on the X-rays or MRIs,

• history of previous extremity surgery,

• history of any systemic disease,

• a BMI of 35 or over.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kim TK, Phillips M, Bhandari M, Watson J, Malhotra R. Erratum to: What Differences in Morphologic Features of the Knee Exist Among Patients of Various Races? A Systematic Review. Clin Orthop Relat Res. 2017 May;475(5):1507. doi: 10.1007/s11999-017-5301-1. — View Citation

Loures FB, Furtado Neto S, Pinto Rde L, Kinder A, Labronici PJ, Góes RF, Marchiori E. Rotational assessment of distal femur and its relevance in total knee arthroplasty: analysis by magnetic resonance imaging. Radiol Bras. 2015 Sep-Oct;48(5):282-6. doi: 10.1590/0100-3984.2014.0037. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	condylar twist angle and posterior condylar angle	The condylar twist angle (CTA) is an angle between anatomical transepicondylar axis (TEA),which lying from medial epicondyle to lateral epicondyle of the distal femur, and posterior condylar axis (PCAx). The posterior condylar angle (PCA) is an angle between surgical TEA, which lying from medial epicondylar sulcus to lateral epicondyle, and PCAx[1].	about 5 days
Secondary	mediolateral lenght of the distal femur (fML)	The widest mediolateral lenght of the distal femur (fML) in the axial plane which equal to transepicondylar axis	about 5 days
Secondary	medial anteroposterior lengt (fMAP) and lateral anteroposterior lengt (fLAP)	the longest anteropesterior distances of the medial and lateral condyles over the cartilage tissue od the distal femur on the axial images[2].	about 5 days
Secondary	Distance between trochlear groove and fMAP (DBTG-fMAP) and distance between trochlear groove and lateral fAP(DBTG- fLAP)	MRI sections obtained 3 cm above the tibiofemoral joint will use for evaluation of deepest point of the trochlear groove.The distance between trochlear groove to fMAP and fLAP	about 5 days
Secondary	Medial and lateral posterior condylar cartilage thicknesses (MPCCT/LPCCT)	MPCCT/LPCCT were measured at the deepest point in the axial plan.	about 5 day