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CompletedNCT02261038Updated Oct 24, 2018

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

An interventional study of Kanekasu radiographs in Osteoarthritis, sponsored by Michael Tobias Hirschmann. Completed at 1 site in Switzerland. Open to participants aged 55 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by Michael Tobias Hirschmann · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
55 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • total knee arthroplasty
  • total knee prothesis
  • X-Ray
  • Kanekasu radiographs
  • femoral component rotation
  • effects
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Michael Tobias Hirschmann is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Total Knee prosthesis (primary)
  • >55 years

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • lactating women
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    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).

    Other: Kanekasu radiographs

Interventions

  • OtherKanekasu radiographs

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

    Also known as: Femoral component rotation, total knee prothesis, X-ray, kanekasu-technic

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: one year

07

Study locations

1 site
  • Kantonsspital Baselland, Bruderholz
    Bruderholz, Baselland 4101, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02261038
Lead sponsor
Michael Tobias Hirschmann
Responsible party
Michael Tobias Hirschmann (PD Dr. med., Kantonsspital Baselland Bruderholz) — Sponsor-investigator
First posted
Oct 10, 2014
Start date
Nov 2014
Primary completion
Feb 1, 2018
Completion
Feb 28, 2018
Last update
Oct 24, 2018

Study contacts

Michael T. Hirschmann, MD
principal investigator · Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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