Knee OsteoarthritisKOA-AXISNCT07168590
Anatomical Axis on X-Ray and Its Relationship With Pain and Kinesiophobia in Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Pain, run by Selim Sezikli at 1 site in Turkey (Türkiye).
Trial summary
Knee osteoarthritis is a common joint disease that causes pain, stiffness, and limitations in daily activities, especially in older adults. Changes in the alignment of the lower limb, called the anatomical axis, can increase the mechanical load on the knee joint and may affect pain and mobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Pain, Kinesiophobia
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2025to 8 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with knee osteoarthritis who are admitted to the Physical Medicine and Rehabilitation outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants must have a knee X-ray taken within the last 6 months and meet the study's eligibility criteria.
Who may be able to join
- Diagnosis of knee osteoarthritis (clinical and radiographic)
- Having an anteroposterior knee X-ray taken within the last 6 months
- Voluntary agreement to participate in the study
- Cognitive ability sufficient to understand test instructions
Who cannot join
- History of knee surgery
- Illiteracy (inability to read/write)
- Refusal to participate
- Presence of orthopedic conditions that prevent walking (e.g., amputation, joint prosthesis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: The Effect of Radiographically Evaluated Anatomical Axis on Pain and Kinesiophobia in Knee Osteoarthritis
Knee osteoarthritis is a common joint disease that causes pain, stiffness, and limitations in daily activities, especially in older adults. Changes in the alignment of the lower limb, called the anatomical axis, can increase the mechanical load on the knee joint and may affect pain and mobility. This study aims to investigate the relationship between the anatomical axis measured on knee X-rays and patients' pain levels, functional status, quality of life, and fear of movement (kinesiophobia).
This is a single-center, observational, cross-sectional study. Adult patients diagnosed with knee osteoarthritis who have a standard knee X-ray taken within the last 6 months and who volunteer to participate will be included. Pain will be measured with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the 36-Item Short Form Health Survey (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). The femoro-tibial angle and joint space width will be measured on X-rays by two independent observers.
By examining the relationship between radiographic alignment and clinical findings, this study may provide new insights into the comprehensive evaluation of knee osteoarthritis and help guide treatment planning for patients.
Read the detailed description
Knee osteoarthritis (OA) is a prevalent degenerative joint disease that leads to pain, disability, and reduced quality of life, particularly in older adults. Alterations in lower limb alignment, specifically deviations of the anatomical (mechanical) axis such as varus or valgus deformities, play a key role in the development and progression of OA by altering joint load distribution. Varus alignment is commonly associated with medial compartment OA, whereas valgus alignment is related to lateral compartment OA. Previous studies have reported that such malalignment may accelerate structural damage, increase pain, and contribute to functional impairment.
In addition to structural changes, chronic pain in OA patients can lead to fear of movement, known as kinesiophobia, which further limits physical activity and negatively affects functional outcomes. However, there are limited studies that simultaneously evaluate the relationship between radiographic alignment, pain, functional capacity, quality of life, and kinesiophobia.
This single-center, observational, cross-sectional study will be conducted at the outpatient Physical Medicine and Rehabilitation clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The target sample size is 100 patients with knee OA, based on a priori power analysis. Eligible participants must have an anteroposterior knee X-ray taken within the last six months. Pain intensity will be assessed with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the Short Form-36 (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). Radiographic measurements, including femoro-tibial angle and joint space width, will be performed by two independent observers using standardized procedures.
Collected data will be analyzed using appropriate statistical methods. The findings are expected to provide a more comprehensive understanding of the relationship between anatomical axis alignment and clinical outcomes in knee OA. This may contribute to more effective treatment planning and patient management.
- Conditions
- Knee Osteoarthritis, Pain, Kinesiophobia
- Keywords
- Knee osteoarthritis, Anatomical axis, Radiographic alignment, Tampa Scale for Kinesiophobia (TSK), SF-36, WOMAC, Pain, Femoro-tibial angle, Kinesiophobia
- Medical subject headings
- Osteoarthritis, Knee, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis Patients | This cohort includes adult patients diagnosed with knee osteoarthritis who meet the inclusion criteria. All participants will undergo clinical evaluation of pain, functional status, quality of life, and kinesiophobia using validated scales (VAS, WOMAC, SF-36, TSK). Radiographic assessment will be performed on existing anteroposterior knee X-rays taken within the last 6 months, including femoro-tibial angle and joint space width measurements. No experimental intervention will be applied; data will be collected in an observational and cross-sectional manner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity Assessed by Visual Analog Scale (VAS)
Pain intensity during daily activities will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain.
Measured: Day 1 (single assessment at baseline)
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia (TSK)
Fear of movement will be measured with the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire widely used in musculoskeletal conditions.
Measured: Day 1 (single assessment at baseline)
Secondary outcomes (4)
Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Functional status, stiffness, and pain will be assessed using the WOMAC index, a validated tool for patients with knee osteoarthritis.
Measured: Day 1 (single assessment at baseline)
Quality of Life Assessed by Short Form-36 (SF-36)
General health-related quality of life will be evaluated using the SF-36, a standardized questionnaire covering physical, emotional, and social domains.
Measured: Day 1 (single assessment at baseline)
Radiographic Alignment Assessed by Femoro-Tibial Angle (FTA)
The anatomical axis of the lower limb will be measured on standard anteroposterior knee radiographs by two independent observers.
Measured: Day 1 (single assessment at baseline)
Joint Space Width (JSW) on Knee X-Ray
Medial and lateral joint space width will be measured on radiographs to evaluate structural severity of knee osteoarthritis.
Measured: Day 1 (single assessment at baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start8 Sep 2025
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selim Sezikli
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Selim Sezikli, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Selim Sezikli, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168590
- Sponsor's protocol ID
- KOA2025
- Acronym
- KOA-AXIS
- Status last verified
- Aug 2025
- First submitted
- 5 Sep 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including demographic information, pain scores (VAS), functional outcomes (WOMAC), quality of life scores (SF-36), kinesiophobia scores (TSK), and radiographic measurements (femoro-tibial angle, joint space width), will be shared. Data will be made available upon reasonable request from qualified researchers with ethics committee approval and a signed data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Radiographically Evaluated Anatomical Axis on Pain and Kinesiophobia in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07168590
- Acronym / sponsor ID
- KOA-AXIS / KOA2025
- Conditions
- Knee Osteoarthritis, Pain, Kinesiophobia
- Keywords
- Knee osteoarthritis, Anatomical axis, Radiographic alignment, Tampa Scale for Kinesiophobia (TSK), SF-36, WOMAC, Pain, Femoro-tibial angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Selim SezikliOther government
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 11 Sep 2025 (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.
Knee osteoarthritis is a common joint disease that causes pain, stiffness, and limitations in daily activities, especially in older adults. Changes in the alignment of the lower limb, called the anatomical axis, can increase the mechanical load on the knee joint and may affect pain and mobility. This study aims to investigate the relationship between the anatomical axis measured on knee X-rays and patients' pain levels, functional status, quality of life, and fear of movement (kinesiophobia).
This is a single-center, observational, cross-sectional study. Adult patients diagnosed with knee osteoarthritis who have a standard knee X-ray taken within the last 6 months and who volunteer to participate will be included. Pain will be measured with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the 36-Item Short Form Health Survey (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). The femoro-tibial angle and joint space width will be measured on X-rays by two independent observers.
By examining the relationship between radiographic alignment and clinical findings, this study may provide new insights into the comprehensive evaluation of knee osteoarthritis and help guide treatment planning for patients.
Detailed description
Knee osteoarthritis (OA) is a prevalent degenerative joint disease that leads to pain, disability, and reduced quality of life, particularly in older adults. Alterations in lower limb alignment, specifically deviations of the anatomical (mechanical) axis such as varus or valgus deformities, play a key role in the development and progression of OA by altering joint load distribution. Varus alignment is commonly associated with medial compartment OA, whereas valgus alignment is related to lateral compartment OA. Previous studies have reported that such malalignment may accelerate structural damage, increase pain, and contribute to functional impairment.
In addition to structural changes, chronic pain in OA patients can lead to fear of movement, known as kinesiophobia, which further limits physical activity and negatively affects functional outcomes. However, there are limited studies that simultaneously evaluate the relationship between radiographic alignment, pain, functional capacity, quality of life, and kinesiophobia.
This single-center, observational, cross-sectional study will be conducted at the outpatient Physical Medicine and Rehabilitation clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The target sample size is 100 patients with knee OA, based on a priori power analysis. Eligible participants must have an anteroposterior knee X-ray taken within the last six months. Pain intensity will be assessed with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the Short Form-36 (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). Radiographic measurements, including femoro-tibial angle and joint space width, will be performed by two independent observers using standardized procedures.
Collected data will be analyzed using appropriate statistical methods. The findings are expected to provide a more comprehensive understanding of the relationship between anatomical axis alignment and clinical outcomes in knee OA. This may contribute to more effective treatment planning and patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis Patients | – | –This cohort includes adult patients diagnosed with knee osteoarthritis who meet the inclusion criteria. All participants will undergo clinical evaluation of pain, functional status, quality of life, and kinesiophobia using validated scales (VAS, WOMAC, SF-36, TSK). Radiographic assessment will be performed on existing anteroposterior knee X-rays taken within the last 6 months, including femoro-tibial angle and joint space width measurements. No experimental intervention will be applied; data will be collected in an observational and cross-sectional manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with knee osteoarthritis who are admitted to the Physical Medicine and Rehabilitation outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants must have a knee X-ray taken within the last 6 months and meet the study's eligibility criteria.
Key inclusion criteria (4 listed)
- Diagnosis of knee osteoarthritis (clinical and radiographic)
- Having an anteroposterior knee X-ray taken within the last 6 months
- Voluntary agreement to participate in the study
- Cognitive ability sufficient to understand test instructions
Key exclusion criteria (4 listed)
- History of knee surgery
- Illiteracy (inability to read/write)
- Refusal to participate
- Presence of orthopedic conditions that prevent walking (e.g., amputation, joint prosthesis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Severity Assessed by Visual Analog Scale (VAS)
Time frame: Day 1 (single assessment at baseline)
Pain intensity during daily activities will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain.
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia (TSK)
Time frame: Day 1 (single assessment at baseline)
Fear of movement will be measured with the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire widely used in musculoskeletal conditions.
4 secondary outcomes
Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Day 1 (single assessment at baseline)
Quality of Life Assessed by Short Form-36 (SF-36)
Time frame: Day 1 (single assessment at baseline)
Radiographic Alignment Assessed by Femoro-Tibial Angle (FTA)
Time frame: Day 1 (single assessment at baseline)
Joint Space Width (JSW) on Knee X-Ray
Time frame: Day 1 (single assessment at baseline)
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including demographic information, pain scores (VAS), functional outcomes (WOMAC), quality of life scores (SF-36), kinesiophobia scores (TSK), and radiographic measurements (femoro-tibial angle, joint space width), will be shared. Data will be made available upon reasonable request from qualified researchers with ethics committee approval and a signed data use agreement.
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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.
Selim Sezikli, MD principal investigator
Istanbul Physical Medicine and Rehabilitation Training and Research 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 and Pain, run by Selim Sezikli at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 6 Oct 2026. 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 Turkey (Türkiye). 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?
Pain Severity Assessed by Visual Analog Scale (VAS) (time frame: Day 1 (single assessment at baseline)). The study lists 2 primary outcomes in all. 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 6 Oct 2026.