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Completed

NCT Number: NCT05656014

The Relationship of the Medial Longitudinal Arch Height With Clinical Features of Knee Osteoarthritis

The goal of this observational study is to investigate the relationships between the medial longitudinal arch (MLA) height of the foot and clinical and radiological characteristics of knee osteoarthritis in adult patients 50 aged and over. The main questions it aims to answer are:

* Is there any relationship between knee pain and disability in knee osteoarthritis and MLA height? * Is there any relationship between the radiologic severity of knee osteoarthritis and MLA height? * Is there any relationship between knee joint alignment in knee osteoarthritis and MLA height?

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Key information

About this study

Differences in hind and midfoot structures, including the medial longitudinal arch, affect lower limb alignment and biomechanics. However, the causal relationship between knee joint problems and foot deformities is controversial. Knee osteoarthritis, a common orthopaedic condition in the elderly population, tends to distort the lower limb alignment by narrowing the tibiofemoral joint space asymmetrically. Therefore, knee varus and medial longitudinal arch deformities may change gait biomechanics on knee osteoarthritis. However, there is insufficient evidence on the relationship between variation in foot posture and disease severity, knee varus deformity, knee pain and disability in knee osteoarthritis. In this study, investigators will examine the lower extremity alignment and osteoarthritis severity in terms of MLA height in adults with knee osteoarthritis.

The study sample will be formed by the simple random sampling method from adult patients with knee osteoarthritis who will be admitted to our clinics and outpatient clinics with knee pain. It was planned to include 93 participants to be able to detect the two-way correlation between the knee WOMAC score and the arch height index with an effect size of 0.3, a power of 90%, and a 5% margin of error.

Initially, demographic data, including age, gender, body mass index (BMI), limb dominance, and time from knee pain onset of participants, will be recorded. For both knees goniometric measurement of knee passive range of motion (ROM), visual analogue scale (VAS) for pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be applied. Kellgren/Lawrence stages, mechanical, and anatomical tibiofemoral angles for knee joints will be obtained from lower limb length X-ray. MLA height index measurement will be performed by an investigator blinded to the patient's clinical condition. According to the results of descriptive statistics, the relationship between MLA height measurement results (arch height index and arch height flexibility) and Kellgren-Lawrence stage, VAS, WOMAC and tibiofemoral angles will be examined by correlation analysis. In case of significant correlation, regression analyses for Kellgren-Lawrence, VAS and WOMAC scores as dependent variables will be applied.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being 50 years old or older
  • Having a diagnosis of knee osteoarthritis according to the American College of Rheumatology

Exclusion criteria

  • History of fracture or orthopaedic surgery involving lower limbs
  • Presence of neurological condition resulting in lower limb sensorimotor deficit
  • Having another inflammatory rheumatological disease
  • Having a malignant tumour with bone metastasis
  • Having lower limb oedema, lymphedema, skin and soft tissue loss that will prevent the evaluation of foot morphology (arch height index)
  • Severe neuropsychiatric disease or condition that interferes with communication
  • Having therapeutic injection into the knee joint in the last 3 months
  • Presence of any major trauma that aggravated knee pain in the last 6 weeks

Treatment and study plan

Primary outcomes

  1. Arch Height Index while bipedal standing

    Time frame: Within the three days of clinical evaluation

    The ratio of the dorsum height of the foot (measured in the middle of the total foot length) to truncated foot length, while bipedal standing. Normal values have been reported to be approximately 0.338 ± 0.031 to 0.343 ± 0.033 in college-aged women. Higher values represent the increased medial longitudinal arch height of the foot (e.g. pes cavus) while lower values are related to pes planus.

  2. Arch Height Index while sitting

    Time frame: Within the three days of clinical evaluation

    The ratio of the dorsum height of the foot (measured in the middle of the total foot length) to truncated foot length, while sitting with feet calmly on the ground. Normal values have been reported to be approximately 0.355 ± 0.031 to 0.369 ± 0.034 in college-aged women. Higher values represent the increased medial longitudinal arch height of the foot (e.g. pes cavus) while lower values are related to pes planus.

  3. Arch Height Flexibility

    Time frame: Within the three days of clinical evaluation

    Arch Height Flexibility will be calculated by the [(arch height while sitting - arch height while standing) / 0.4 x body weight] x 100 (m/kN) formula. Higher values represent the more flexible medial longitudinal arch structure.

  4. Kellgren Lawrence stage of knee osteoarthritis

    Time frame: Within the three days of clinical evaluation

    It is a radiological grading of knee osteoarthritis with a value between 0 to 4. Medial and lateral tibiofemoral compartments are evaluated on weight-bearing anteroposterior knee radiograph in terms of joint space narrowing, subchondral periosteal sclerosis, subchondral cyst and osteophytic formations. Zero means no radiographic evidence of osteoarthritis, while 4 indicates advanced knee osteoarthritis.

  5. Anatomical tibiofemoral angle

    Time frame: Within the three days of clinical evaluation

    It is the angle, measured on a weight-bearing, full-length anteroposterior lower limb radiograph, between the anatomical axes of the femur and tibia. The normal value of the anatomical tibiofemoral angle is between 4 to 6 degrees of valgus. A higher positive value will indicate more valgus posture of the knee, while lower or negative values will be related to varus deformity.

  6. Mechanical tibiofemoral angle

    Time frame: Within the three days of clinical evaluation

    It is the angle, measured on a weight-bearing, full-length anteroposterior lower limb radiograph, between the lines drawn from the femoral head to the femoral intercondylar notch and from the tibial interspinous point to the tibial mid-plafond. The mechanical tibiofemoral angle is approximately 1-1.5 degrees of varus for a knee in normal alignment. In this study, to ensure consistency with the anatomical tibiofemoral angle values, the direction of angulation will be noted as a positive or negative value for the valgus or varus, respectively.

  7. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for both knees

    Time frame: Within the three days of clinical evaluation

    WOMAC is a specific, valid and reliable tool for measuring disability in the knee and hip osteoarthritis. It includes 24 questions under three sub-domains: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=none, 1=mild, 2=moderate, 3=severe, and 4=extreme. The total score is defined by the [(sum of the scores)/96]x100 formula and ranges from 0 to 100. Higher scores indicate increased disability due to more severe pain, stiffness and impaired physical function.

  8. Visual analogous scale score for knee pain

    Time frame: Within the three days of clinical evaluation

    Participants are asked to mark the severity of their right and left knee pain in the past month on a 100 mm horizontal line; where point zero represents "no pain" and point 100 represents "the most severe pain possible". The result is noted in millimetres by measuring the distance from the "zero" to the marked point. Increasing values represent higher pain intensity.

Secondary outcomes

  1. Knee range of motions

    Time frame: Within the day of clinical evaluation

    Flexion and extension range of motions will be measured using a goniometer regarding the neutral zero method for both knees. Decreased values represent a limited range of motion of the knee joint.

  2. Time after pain onset (weeks)

    Time frame: Within the day of clinical evaluation

    The duration of knee pain leading to hospital admission will be noted.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Relationship of Medial Longitudinal Arch Height With Pain, Disease Severity and Knee Joint Alignment in Patients With Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2022
Registry last updated
Aug 12, 2024

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

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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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