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

NCT05656014 | Completed

• 1 other identifier: Knee osteoarthritis and AHI
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Foot Deformities; Pes Planus; Pes Cavus; Knee Osteoarthritis; Knee Pain Chronic; Disability Physical; Lower Limb Deformity

Keywords

Medial longitudinal arch; Arch height index; Knee osteoarthritis; Knee pain; Foot; Lower limb alignment

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Knee range of motions

  Within the day of clinical evaluation

• Time after pain onset (weeks)

  Within the day of clinical evaluation

Study Arms (1)

Patients with knee osteoarthritis

Adult patients 50 years of age or older diagnosed with knee osteoarthritis according to American College of Rheumatology criteria

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients 50 years of age or older diagnosed with osteoarthritis of one or both knees according to the American College of Rheumatology criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related 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.

  PMID: 3741515 BACKGROUND

• 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.

  PMID: 10960934 BACKGROUND

• 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.

  PMID: 23697727 BACKGROUND

• 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.

  PMID: 23107625 BACKGROUND

• 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.

  PMID: 28198638 BACKGROUND

• 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.

  PMID: 31023006 BACKGROUND

• 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.

  PMID: 34267938 BACKGROUND

• 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.

  PMID: 3597474 BACKGROUND

MeSH Terms

Conditions

Foot Deformities; Flatfoot; Talipes Cavus; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Levent Karataş, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, MD

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: December 7, 2022
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)