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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261038
• Other study ID #: Rad-2CT-3CT_001_MH
• Secondary ID: 332/13
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2018
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

Inclusion Criteria:

• Total Knee prosthesis (primary)

• >55 years

Exclusion Criteria:

• pregnancy

• lactating women

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baselland, Bruderholz	Bruderholz	Baselland

Sponsors (1)

Lead Sponsor	Collaborator
Michael Tobias Hirschmann

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral TKA component rotation in degrees	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.	one year
Secondary	Inter- and intraobserver reliability of TKA femoral component rotation	Inter- and intraobserver reliability of TKA femoral component rotation are calculated by intra class correlation coefficients (ICC) and compared between all three measurement methods.	one year