NCT04355182

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 17, 2020

Last Update Submit

April 20, 2020

Conditions

Keywords

posterior condylar angletotal knee arthroplastyexternal rotationanthropometric measurements3 degreesTurkish population

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • mediolateral lenght of the distal femur (fML)

    about 5 days

  • medial anteroposterior lengt (fMAP) and lateral anteroposterior lengt (fLAP)

    about 5 days

  • Distance between trochlear groove and fMAP (DBTG-fMAP) and distance between trochlear groove and lateral fAP(DBTG- fLAP)

    about 5 days

  • Medial and lateral posterior condylar cartilage thicknesses (MPCCT/LPCCT)

    about 5 day

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healty subjects with Turkish ethnic orijin

You may qualify if:

  • non-arthritic knees,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26543278BACKGROUND
  • 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.

    PMID: 28255946BACKGROUND

Study Officials

  • Nurdan Güngören

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intorn Doctor, Faculty of Medicine, Principal Investigator

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

February 1, 2020

Primary Completion

March 30, 2020

Study Completion

April 12, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations