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

NCT ID: NCT05656014

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-07

Study Completion Date

2024-06-03

Brief Summary

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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?

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with knee osteoarthritis

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Levent Karataş

Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Levent Karataş, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University Faculty of Medicine

Locations

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Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 3741515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10960934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23697727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23107625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28198638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31023006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34267938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3597474 (View on PubMed)

Other Identifiers

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Knee osteoarthritis and AHI

Identifier Type: -

Identifier Source: org_study_id

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