Knee OsteoarthritisNCT05295602
The Influence of Coronally Knee Alignment on the Tibial Tuberosity Rotation
An observational study of Knee Osteoarthritis, run by Valdoltra Orthopedic Hospital at 1 site in Slovenia.
Trial summary
The primary aim of this study is to find a possible correlation between tibial tuberosity rotation and coronal leg alignment. If correlation exists, a more individual tibial component rotation might be proposed during a total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2021to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients waiting for the knee arthroplasty will be asked to participate. Patients with pre-existing deformities will not be enrolled. Additionally, women in reproductive age will also not be enrolled to avoid unnecessary radiation risks.
Who may be able to join
- patients requiring knee arthroplasty
Who cannot join
- women in reproductive age, patients with leg deformities and previous hip/knee surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Radiological Lower Limb Alignment and Grade of the Knee Osteoarthritis With the Position of the Tibial Tuberosity
The primary aim of this study is to find a possible correlation between tibial tuberosity rotation and coronal leg alignment. If correlation exists, a more individual tibial component rotation might be proposed during a total knee arthroplasty.
Read the detailed description
A malalignment of the tibial component is a possible source of pain after a total knee arthroplasty. Currently, an internal rotation of the tibial component of 18 degrees is considered as a golden standard. The value was obtained as an average rotation in the osteoarthritic knees scheduled for a total knee arthroplasty.
It is known that the femur internally rotates with the increasing valgus alignment. It would seem logical that also tibial rotation correlates with the coronal limb alignment (varus-valgus). The plan is to measure the native tibial rotation (angle between the transposed epicondylar line and the posterior cruciate-tibial tuberosity line). In order to get the necessary accuracy a CT of lower legs will be obtained in patients waiting for the knee replacement. If there is a correlation between the angles the adjustment of the tibial component rotation more to the patient's anatomy could be proposed.
A secondary outcome measure is the possible correlation between the proximal femoral anteversion and the tibial tuberosity rotation. The hypothesis is that the extensor mechanism follows the proximal femoral orientation. With increasing femoral anteversion (increases with valgus angle) the femoral part of the knee rotates internally. In order to keep the extensor mechanism in the direction of walking, a more lateralized position of the tibial tuberosity is expected.
- Conditions
- Knee Osteoarthritis
- Being tested
- CT scan
- Keywords
- knee alignment, knee arthroplasty, tibial component rotation
- 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 lower leg
| Study group | Role | What they receive |
|---|---|---|
| Group | A CT scan of both legs will be made in patient scheduled for a primary knee arthroplasty. No other additional intervention will be made apart from those already routinely used for the operation. Receives: Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between coronal alignment and tibial tuberosity rotation
A hip-knee-ankle angle and a tibial rotation angle (angle between the transposed epicondylar line) will be calculated from the CT scan of the leg. A correlation between both angles will be analysed using the Spearmans's coefficient.
Measured: Before surgery
Secondary outcomes (2)
Correlation between femoral anteversion and tibial tuberosity position
A femoral anteversion angle (angle between femoral hip neck and posterior condylar knee line) and tibial tuberosity position (angle between posterior condylar line and posterior cruciate - tibial tuberosity line) will be measured and examined for correlation using a Spearman's coefficient.
Measured: Before surgery
Difference in tibial tuberosity position according to the osteoarthritis grade
Tibial tuberosity position will be compared according to the Kellgren-Lawrence grade with the ANOVA
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 posted25 Mar 2022
- Study start1 Dec 2021
- Primary completion15 Dec 2023
- Study completion1 Jan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT05295602
- Sponsor's protocol ID
- Valdoltra - TT rotation
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2022
- Last updated
- 3 Mar 2025
- Results posted
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Radiological Lower Limb Alignment and Grade of the Knee Osteoarthritis With the Position of the Tibial Tuberosity
- ClinicalTrials.gov ID
- NCT05295602
- Acronym / sponsor ID
- Valdoltra - TT rotation
- Conditions
- Knee Osteoarthritis
- Keywords
- knee alignment, knee arthroplasty, tibial component rotation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Valdoltra Orthopedic HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 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 primary aim of this study is to find a possible correlation between tibial tuberosity rotation and coronal leg alignment. If correlation exists, a more individual tibial component rotation might be proposed during a total knee arthroplasty.
Detailed description
A malalignment of the tibial component is a possible source of pain after a total knee arthroplasty. Currently, an internal rotation of the tibial component of 18 degrees is considered as a golden standard. The value was obtained as an average rotation in the osteoarthritic knees scheduled for a total knee arthroplasty.
It is known that the femur internally rotates with the increasing valgus alignment. It would seem logical that also tibial rotation correlates with the coronal limb alignment (varus-valgus). The plan is to measure the native tibial rotation (angle between the transposed epicondylar line and the posterior cruciate-tibial tuberosity line). In order to get the necessary accuracy a CT of lower legs will be obtained in patients waiting for the knee replacement. If there is a correlation between the angles the adjustment of the tibial component rotation more to the patient's anatomy could be proposed.
A secondary outcome measure is the possible correlation between the proximal femoral anteversion and the tibial tuberosity rotation. The hypothesis is that the extensor mechanism follows the proximal femoral orientation. With increasing femoral anteversion (increases with valgus angle) the femoral part of the knee rotates internally. In order to keep the extensor mechanism in the direction of walking, a more lateralized position of the tibial tuberosity is expected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Radiation: CT scanA CT scan of both legs will be made in patient scheduled for a primary knee arthroplasty. No other additional intervention will be made apart from those already routinely used for the operation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients waiting for the knee arthroplasty will be asked to participate. Patients with pre-existing deformities will not be enrolled. Additionally, women in reproductive age will also not be enrolled to avoid unnecessary radiation risks.
Key inclusion criteria (1 listed)
- patients requiring knee arthroplasty
Key exclusion criteria (1 listed)
- women in reproductive age, patients with leg deformities and previous hip/knee surgery
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 lower leg | Radiation | Group |
Primary outcome
Correlation between coronal alignment and tibial tuberosity rotation
Time frame: Before surgery
A hip-knee-ankle angle and a tibial rotation angle (angle between the transposed epicondylar line) will be calculated from the CT scan of the leg. A correlation between both angles will be analysed using the Spearmans's coefficient.
2 secondary outcomes
Correlation between femoral anteversion and tibial tuberosity position
Time frame: Before surgery
Difference in tibial tuberosity position according to the osteoarthritis grade
Time frame: Before surgery
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 3 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 3 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?
Correlation between coronal alignment and tibial tuberosity rotation (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 3 Mar 2025.