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

NCT05277883 | Completed

• 1 other identifier: Valdoltra - x-ray accuracy
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

knee aligment; total knee arthroplasty; coronal alignment of the lower limb; x-ray accuracy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Radiation: CT scan

Interventions

CT scan RADIATION

CT of the lower limb

Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Knee osteoarthritis scheduled for knee arthroplasty

You may not qualify if:

• previous leg deformities or surgery that changes alignment

Sponsors & Collaborators

• Valdoltra Orthopedic Hospital: lead

Study Sites (1)

Orthopaedic Hospital Valdoltra

Ankaran, Slovenia, 6820, Slovenia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andrej Strahovnik

  Valdoltra Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: December 1, 2022
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: March 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)