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Clinical Trials/NCT04481711
NCT04481711
Completed
N/A

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

Karadeniz Technical University1 site in 1 country51 target enrollmentNovember 8, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Orthopedic Disorder
Sponsor
Karadeniz Technical University
Enrollment
51
Locations
1
Primary Endpoint
Pain severity
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2018
End Date
May 8, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Murat EMİRZEOĞLU

Karadeniz Technical University

Karadeniz Technical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain severity

Time Frame: 15 minutes

The pain intensity were evaluated by the Visuel Analog Scale.

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

Functional status

Time Frame: 30 minutes

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

Proinflammatory cytokine level

Time Frame: 30 minutes

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

Joint position sense

Time Frame: 30 minutes

Electro-goniometer was used for proprioception evaluation

Study Sites (1)

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