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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02261038
Enrollment
50
Registered
2014-10-10
Start date
2014-11-30
Completion date
2018-02-28
Last updated
2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

total knee arthroplasty, total knee prothesis, X-Ray, Kanekasu radiographs, femoral component rotation, effects

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.

Interventions

OTHERKanekasu radiographs

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

Sponsors

Michael Tobias Hirschmann
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* Total Knee prosthesis (primary) * \>55 years

Exclusion criteria

* pregnancy * lactating women

Design outcomes

Primary

MeasureTime frameDescription
Femoral TKA component rotation in degreesone yearFemoral 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

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026