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
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
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
NCT ID
NCT02261038
First Posted
July 28, 2014
Last Updated
October 22, 2018
Sponsor
Michael Tobias Hirschmann
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
Learn more about this trial
Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT
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