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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Kanekasu radiographs
Sponsored by
Michael Tobias Hirschmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis focused on measuring total knee arthroplasty, total knee prothesis, X-Ray, Kanekasu radiographs, femoral component rotation, effects

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Total Knee prosthesis (primary)
  • >55 years

Exclusion Criteria:

  • pregnancy
  • lactating women

Sites / Locations

  • Kantonsspital Baselland, Bruderholz

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Kanekasu radiographs

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2014
Last Updated
October 22, 2018
Sponsor
Michael Tobias Hirschmann
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1. Study Identification

Unique Protocol Identification Number
NCT02261038
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Tobias Hirschmann

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
total knee arthroplasty, total knee prothesis, X-Ray, Kanekasu radiographs, femoral component rotation, effects

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kanekasu radiographs
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Kanekasu radiographs
Other Intervention Name(s)
Femoral component rotation, total knee prothesis, X-ray, kanekasu-technic
Intervention Description
No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.
Primary Outcome Measure Information:
Title
Femoral TKA component rotation in degrees
Description
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 Outcome Measure Information:
Title
Inter- and intraobserver reliability of TKA femoral component rotation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Total Knee prosthesis (primary) >55 years Exclusion Criteria: pregnancy lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T. Hirschmann, MD
Organizational Affiliation
Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baselland, Bruderholz
City
Bruderholz
State/Province
Baselland
ZIP/Postal Code
4101
Country
Switzerland

12. IPD Sharing Statement

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

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