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Completed

NCT Number: NCT02261038

Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT

Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.

Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.

It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.

Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baselland, Bruderholz

Bruderholz, Basel-Landschaft, 4101, Switzerland

About this study

Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.

Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.

It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.

In agreement with our standard diagnostic algorithm for patients with pain and problems after TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is comparable reliable, it could be possible to use this radiograph instead.

Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees. The measurements are performed with two weeks interval and the different observers are blinded to their previous and the measurements of the others.

The absolute difference of femoral TKA rotation is calculated between and inter the groups investigated.

Intra class correlation coefficients are calculated for inter- and intraobserver reliability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Total Knee prosthesis (primary)
  • >55 years

Exclusion criteria

  • pregnancy
  • lactating women

Treatment and study plan

Kanekasu radiographs

Other

No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.

Other names: Femoral component rotation, total knee prothesis, X-ray, kanekasu-technic

Primary outcomes

  1. Femoral TKA component rotation in degrees

    Time frame: one year

    Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.

Secondary outcomes

  1. Inter- and intraobserver reliability of TKA femoral component rotation

    Time frame: one year

    Inter- and intraobserver reliability of TKA femoral component rotation are calculated by intra class correlation coefficients (ICC) and compared between all three measurement methods.

Sponsors and collaborators

Lead sponsor

Michael Tobias Hirschmann

Other

Registry information

Official study title

Comparative Study pf the Femoral Prothesis-rotation in Conventional X-Ray, in Axial CT Slices and 3D-reconstructed CT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2014
Registry last updated
Oct 24, 2018

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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