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

April 20, 2020 updated by: Nurdan Güngören, Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34093
        • Bezmialem Vakıf University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healty subjects with Turkish ethnic orijin

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
condylar twist angle and posterior condylar angle
Time Frame: about 5 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mediolateral lenght of the distal femur (fML)
Time Frame: about 5 days
The widest mediolateral lenght of the distal femur (fML) in the axial plane which equal to transepicondylar axis
about 5 days
medial anteroposterior lengt (fMAP) and lateral anteroposterior lengt (fLAP)
Time Frame: about 5 days
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
Distance between trochlear groove and fMAP (DBTG-fMAP) and distance between trochlear groove and lateral fAP(DBTG- fLAP)
Time Frame: about 5 days
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
Medial and lateral posterior condylar cartilage thicknesses (MPCCT/LPCCT)
Time Frame: about 5 day
MPCCT/LPCCT were measured at the deepest point in the axial plan.
about 5 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nurdan Güngören, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

April 12, 2020

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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