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NCT05277883 Clinical Trial

Influence of Knee Alignment and Pelvis Rotation on Accuracy of Radiograph Measurements Before Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:
The Influence of Lower Extremity and Pelvic Alignment on Accuracy of Hip-Knee-Ankle Radiograph Measurements Before Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05277883
Other study ID # Valdoltra - x-ray accuracy
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2022
Est. completion date December 2023

Study information
Verified date March 2022
Source Valdoltra Orthopedic Hospital
Contact Igor Strahovnik
Phone +38631423369
Email istrah@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the accuracy of long leg standing X-rays with respect to coronal alignment of the knee.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: Knee osteoarthritis scheduled for knee arthroplasty Exclusion Criteria: - previous leg deformities or surgery that changes alignment

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• CT scan
CT of the lower limb

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Valdoltra Orthopedic Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The angle difference between an x-ray and a CT scan 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. Before surgery
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