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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Kanekasu radiographs

• Registration Number: NCT02261038
• Lead Sponsor: Michael Tobias Hirschmann

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Study Start: 2014-11
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Total Knee prosthesis (primary)
• >55 years

Exclusion Criteria

• pregnancy
• lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kanekasu radiographs	Kanekasu radiographs	No drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique).

Primary Outcome Measures

Name	Time	Method
Femoral TKA component rotation in degrees	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 Outcome Measures

Name	Time	Method
Inter- and intraobserver reliability of TKA femoral component rotation	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.

Trial Locations

Locations (1)

Kantonsspital Baselland, Bruderholz; 🇨🇭 Bruderholz, Baselland, Switzerland