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Clinical Trials/NCT02261038
NCT02261038
Completed
Not Applicable

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

Michael Tobias Hirschmann1 site in 1 country50 target enrollmentNovember 2014
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Michael Tobias Hirschmann
Enrollment
50
Locations
1
Primary Endpoint
Femoral TKA component rotation in degrees
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Michael Tobias Hirschmann
Responsible Party
Sponsor Investigator
Principal Investigator

Michael Tobias Hirschmann

PD Dr. med.

Kantonsspital Baselland Bruderholz

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • pregnancy
  • lactating women

Outcomes

Primary Outcomes

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

  • Inter- and intraobserver reliability of TKA femoral component rotation(one year)

Study Sites (1)

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