Total Knee Arthroplasty and Clinical Findings

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Arthropathy of Knee; Radiography; Proprioception; Pain, Joint
• Intervention / Treatment: Procedure: Total Knee Arthroplasty

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye
    • Trabzon, Türkiye, Turkey, 61080
      • Karadeniz Technical Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty	Procedure: Total Knee Arthroplasty; 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.
NO_INTERVENTION: Control group; Twenty-two patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proinflammatory cytokine level	Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.	30 minutes
Pain severity	The pain intensity were evaluated by the Visuel Analog Scale.	15 minutes
Functional status	The Western Ontario and McMaster Universities Arthritis Index was used for functional status.	30 minutes
Joint position sense	Electro-goniometer was used for proprioception evaluation	30 minutes
Valgity angle and amount of malaligment	In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist	30 minutes

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Study Chair: Murat Emirzeoğlu, Karadeniz Technical University; Study Director: Arzu Erden, Karadeniz Technical University; Study Chair: Kübra canlı, Hacettepe University; Study Chair: Serap Özer Yaman, Karadeniz Technical University; Study Chair: İbrahim Pekşen, Karadeniz Technical University; Study Chair: Osman Aynacı, Karadeniz Technical University; Study Chair: Süleyman Caner Karahan, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2018
• Primary Completion (ACTUAL): February 8, 2020
• Study Completion (ACTUAL): May 8, 2020

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (ACTUAL): July 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Arthralgia; Musculoskeletal Diseases
• Other Study ID Numbers: 2018-91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No