Influence of Knee Alignment and Pelvis Rotation on Accuracy of Radiograph Measurements Before Total Knee Arthroplasty
March 25, 2025 updated by: Valdoltra Orthopedic Hospital
The Influence of Lower Extremity and Pelvic Alignment on Accuracy of Hip-Knee-Ankle Radiograph Measurements Before Total Knee Arthroplasty
The aim of this study is to determine the accuracy of long leg standing X-rays with respect to coronal alignment of the knee.
Study Overview
Detailed Description
Long leg standing x-ray is a routine examination to measure the femoral valgus angle before a total knee arthroplasty. Newer studies have shown that coronal leg alignment influences the rotation of the distal femoral part. This rotation might influence the measurements obtained with a long leg standing x-ray.
The primary purpose of this study is to determine whether there is a significant difference between 2D measurements taken on the x-ray and 3D measurements obtained with a CT scan.
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankaran, Slovenia, 6820
- Orthopaedic Hospital Valdoltra
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients that require primary knee replacement will be enrolled in the study.
Patients with prevoius surgery that might had already changed the leg aligment (hip/knee artroplasty, osteotomy) or patients with previous leg deformity are not eligible for the enrolment.
Women in reproductive age are also not eligible.
Description
Inclusion Criteria:
Knee osteoarthritis scheduled for knee arthroplasty
Exclusion Criteria:
- previous leg deformities or surgery that changes alignment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group
All patients scheduled for a total knee arthroplasty without any previous lower limb deformities or previous hip/knee surgery will be enrolled.
A long leg standing x-ray and a CT scan of the lower limb will be obtained for every patient.
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CT of the lower limb
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The angle difference between an x-ray and a CT scan
Time Frame: Before surgery
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The femoral valgus angle, femoral mechanical angle, tibial mechanical angle and hip knee ankle angle are measured separately on the x-ray and on the CT scan.
The difference in individual angle is the calculated.
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Before surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrej Strahovnik, Valdoltra Orthopaedic Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Actual)
December 25, 2024
Study Completion (Actual)
December 25, 2024
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 30, 2025
Last Update Submitted That Met QC Criteria
March 25, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Valdoltra - x-ray accuracy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.