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NCT Number: NCT07168590

Anatomical Axis on X-Ray and Its Relationship With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location status: Recruiting

Location contact

Canan Avcı, MD

SUB_INVESTIGATOR

Cansın Medin Ceylan, Assoc. Prof.

SUB_INVESTIGATOR

Merve Damla Korkmaz, Assoc. Prof.

SUB_INVESTIGATOR

Nazlı Derya Bugdaycı, Prof.

SUB_INVESTIGATOR

Selim Sezikli, MD

CONTACT

[email protected]

+90 (212) 496 50 00

Selim Sezikli, MD

PRINCIPAL_INVESTIGATOR

Yelda Soluk Ozdemir, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • History of knee surgery
  • Illiteracy (inability to read/write)
  • Refusal to participate
  • Presence of orthopedic conditions that prevent walking (e.g., amputation, joint prosthesis)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Functional Status Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Day 1 (single assessment at baseline)

    Functional status, stiffness, and pain will be assessed using the WOMAC index, a validated tool for patients with knee osteoarthritis.

  2. Quality of Life Assessed by Short Form-36 (SF-36)

    Time frame: Day 1 (single assessment at baseline)

    General health-related quality of life will be evaluated using the SF-36, a standardized questionnaire covering physical, emotional, and social domains.

  3. Radiographic Alignment Assessed by Femoro-Tibial Angle (FTA)

    Time frame: Day 1 (single assessment at baseline)

    The anatomical axis of the lower limb will be measured on standard anteroposterior knee radiographs by two independent observers.

  4. Joint Space Width (JSW) on Knee X-Ray

    Time frame: Day 1 (single assessment at baseline)

    Medial and lateral joint space width will be measured on radiographs to evaluate structural severity of knee osteoarthritis.

Study contacts

Contact information is provided by the study sponsor or research team.

Cansın Medin Ceylan, Assoc. Prof.

CONTACT

[email protected]

+90 531 575 95 39

Selim Sezikli, MD

CONTACT

[email protected]

+90 506 510 18 33

Sponsors and collaborators

Lead sponsor

Selim Sezikli

Other Gov

Registry information

Official study title

The Effect of Radiographically Evaluated Anatomical Axis on Pain and Kinesiophobia in Knee Osteoarthritis

Acronym: KOA-AXIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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