- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355182
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.
Sponsor
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.
General Publications
- Loures FB, Furtado Neto S, Pinto Rde L, Kinder A, Labronici PJ, Goes 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.
- 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. No abstract available.
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
Keywords
Other Study ID Numbers
- 3586
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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