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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656014
• Other study ID #: Knee osteoarthritis and AHI
• Status: Recruiting
• Start date: December 7, 2022
• Est. completion date: May 28, 2024

Study information

• Verified date: April 2024
• Source: Gazi University
• Contact: Levent Karatas, MD
• Phone: +903122025215
• Email: leventkaratas[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Disability Physical
• Flatfoot
• Foot Deformities
• Knee Osteoarthritis
• Knee Pain Chronic
• Lower Limb Deformity
• Osteoarthritis
• Osteoarthritis, Knee
• Pes Planus

Locations

Country	Name	City	State
Turkey	Gazi University Hospital, Department of Physical Medicine and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816. — View Citation

Hillstrom HJ, Song J, Kraszewski AP, Hafer JF, Mootanah R, Dufour AB, Chow BS, Deland JT 3rd. Foot type biomechanics part 1: structure and function of the asymptomatic foot. Gait Posture. 2013 Mar;37(3):445-51. doi: 10.1016/j.gaitpost.2012.09.007. Epub 2012 Oct 26. — View Citation

Karatas L, Vuralli D, Gunendi Z. The effect of medial longitudinal arch height and medial longitudinal arch support insoles on postural balance in perimenopausal women. Turk J Med Sci. 2019 Jun 18;49(3):755-760. doi: 10.3906/sag-1808-39. — View Citation

Marques Luis N, Varatojo R. Radiological assessment of lower limb alignment. EFORT Open Rev. 2021 Jun 28;6(6):487-494. doi: 10.1302/2058-5241.6.210015. eCollection 2021 Jun. — View Citation

Moreland JR, Bassett LW, Hanker GJ. Radiographic analysis of the axial alignment of the lower extremity. J Bone Joint Surg Am. 1987 Jun;69(5):745-9. — View Citation

Weimar WH, Shroyer JF. Arch height index normative values of college-aged women using the arch height index measurement system. J Am Podiatr Med Assoc. 2013 May-Jun;103(3):213-7. doi: 10.7547/1030213. — View Citation

Williams DS, McClay IS. Measurements used to characterize the foot and the medial longitudinal arch: reliability and validity. Phys Ther. 2000 Sep;80(9):864-71. — View Citation

Zifchock RA, Theriot C, Hillstrom HJ, Song J, Neary M. The Relationship Between Arch Height and Arch FlexibilityA Proposed Arch Flexibility Classification System for the Description of Multidimensional Foot Structure. J Am Podiatr Med Assoc. 2017 Mar;107(2):119-123. doi: 10.7547/15-051. Epub 2017 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arch Height Index while bipedal standing	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.	Within the three days of clinical evaluation
Primary	Arch Height Index while sitting	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.	Within the three days of clinical evaluation
Primary	Arch Height Flexibility	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.	Within the three days of clinical evaluation
Primary	Kellgren Lawrence stage of knee osteoarthritis	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.	Within the three days of clinical evaluation
Primary	Anatomical tibiofemoral angle	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.	Within the three days of clinical evaluation
Primary	Mechanical tibiofemoral angle	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.	Within the three days of clinical evaluation
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for both knees	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.	Within the three days of clinical evaluation
Primary	Visual analogous scale score for knee pain	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.	Within the three days of clinical evaluation
Secondary	Knee range of motions	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.	Within the day of clinical evaluation
Secondary	Time after pain onset (weeks)	The duration of knee pain leading to hospital admission will be noted.	Within the day of clinical evaluation