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Completed

NCT Number: NCT04481711

Total Knee Arthroplasty and Clinical Findings

Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity angle,malaligment, functional status and knee joint position sense.

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Key information

Conditions

Orthopedic Disorder Arthralgia Arthropathy of Knee Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Joint Pathological Conditions, Signs and Symptoms Proprioception Radiography Signs and Symptoms

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical Üniversitesi

Trabzon, Türkiye, 61080, Turkey (Türkiye)

About this study

Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA group (study group) and 22 patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group. Systemic venous blood samples of the patients were taken to evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score was used to evaluate the functional status. Valgity and malaligment measurements were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken once from patients in the control group, and twice in pre-op and post-op sixth weeks from study group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group.
  • Patients without surgical indication, lower than 4 OA severity included in the control group

Exclusion criteria

  • Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study

Treatment and study plan

Total knee arthroplasty

Procedure

Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.

Primary outcomes

  1. Proinflammatory cytokine level

    Time frame: 30 minutes

    Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.

  2. Pain severity

    Time frame: 15 minutes

    The pain intensity were evaluated by the Visuel Analog Scale.

  3. Functional status

    Time frame: 30 minutes

    The Western Ontario and McMaster Universities Arthritis Index was used for functional status.

  4. Joint position sense

    Time frame: 30 minutes

    Electro-goniometer was used for proprioception evaluation

  5. Valgity angle and amount of malaligment

    Time frame: 30 minutes

    In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Investigation of the Effect of Total Knee Arthroplasty on Proinflammatory Cytokine Level, Pain Severity, Functional Status, Joint Position Sense and Radiographic Findings

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2020
Registry last updated
Jul 24, 2020

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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