Clinical trial NCT02261038: Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT
Official title: Comparative Study pf the Femoral Prothesis-rotation in Conventional X-Ray, in Axial CT Slices and 3D-reconstructed CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
total knee prothesis
X-Ray
Kanekasu radiographs
femoral component rotation
effects
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnancy
* lactating women

Primary outcomes:
measure: Femoral TKA component rotation in degrees
timeFrame: one year
Secondary outcomes:
measure: Inter- and intraobserver reliability of TKA femoral component rotation
timeFrame: one year
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland, Bruderholz
state: Baselland
Study officials:
affiliation: Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
name: Michael T. Hirschmann, MD
role: PRINCIPAL_INVESTIGATOR
References: