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Completed

NCT Number: NCT04355182

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

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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].

Secondary outcomes

  1. 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

  2. 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].

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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