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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1 (single assessment at baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (single assessment at baseline) |
| Quality of Life Assessed by Short Form-36 (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selim Sezikli, MD | Contact | +90 506 510 18 33 | selimsezikli@hotmail.com | |
| Cansın Medin Ceylan, Assoc. Prof. | Contact | +90 531 575 95 39 | cansinmedin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Selim Sezikli, MD | Istanbul Physical Medicine and Rehabilitation Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Physical Medicine and Rehabilitation Training and Research Hospital | Recruiting | Istanbul | 34186 | Turkey (Türkiye) |
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.
De-identified individual participant data and supporting documents (protocol, SAP, ICF) will be available beginning 6 months after study completion (September 2026) and will remain available for up to 2 years (until March 2028).
Qualified researchers with approval from an independent ethics committee and a signed data use agreement will be granted access to de-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form). Data will be shared in anonymized format to ensure patient confidentiality. Access requests should be submitted to the principal investigator, and data will be provided electronically after approval.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D000092442 | Kinesiophobia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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General health-related quality of life will be evaluated using the SF-36, a standardized questionnaire covering physical, emotional, and social domains. |
| 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. | 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. | Day 1 (single assessment at baseline) |
| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |