Knee OsteoarthritisNCT05277883
Influence of Knee Alignment and Pelvis Rotation on Accuracy of Radiograph Measurements Before Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Valdoltra Orthopedic Hospital at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2022to 25 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Knee osteoarthritis scheduled for knee arthroplasty
Who cannot join
- previous leg deformities or surgery that changes alignment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- CT scan
- Keywords
- knee aligment, total knee arthroplasty, coronal alignment of the lower limb, x-ray accuracy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
CT of the lower limb
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Dec 2022
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valdoltra Orthopedic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrej Strahovnik, Principal investigator, Valdoltra Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277883
- Sponsor's protocol ID
- Valdoltra - x-ray accuracy
- Status last verified
- Dec 2024
- First submitted
- 3 Mar 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Lower Extremity and Pelvic Alignment on Accuracy of Hip-Knee-Ankle Radiograph Measurements Before Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05277883
- Acronym / sponsor ID
- Valdoltra - x-ray accuracy
- Conditions
- Knee Osteoarthritis
- Keywords
- knee aligment, total knee arthroplasty, coronal alignment of the lower limb, x-ray accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Valdoltra Orthopedic HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the accuracy of long leg standing X-rays with respect to coronal alignment of the knee.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Radiation: CT scanAll 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Knee osteoarthritis scheduled for knee arthroplasty
Key exclusion criteria (1 listed)
- previous leg deformities or surgery that changes alignment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanCT of the lower limb | Radiation | Group |
Primary outcome
The angle difference between an x-ray and a CT scan
Time frame: Before surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Strahovnik principal investigator
Valdoltra Orthopaedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Valdoltra Orthopedic Hospital at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The angle difference between an x-ray and a CT scan (time frame: Before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.