Total Knee Arthroplasty and Clinical Findings

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481711
• Other study ID #: 2018-91
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: May 8, 2020

Study information

• Verified date: July 2020
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 8, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Arthropathy of Knee
• Joint Diseases
• Musculoskeletal Diseases
• Orthopedic Disorder
• Pain, Joint
• Proprioception
• Radiography

Intervention

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.

Locations

Country	Name	City	State
Turkey	Karadeniz Technical Üniversitesi	Trabzon	Türkiye

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proinflammatory cytokine level	Systemic venous blood samples were taken. IL-6, TNF-a and IL-1ß cytokine levels were examined.	30 minutes
Primary	Pain severity	The pain intensity were evaluated by the Visuel Analog Scale.	15 minutes
Primary	Functional status	The Western Ontario and McMaster Universities Arthritis Index was used for functional status.	30 minutes
Primary	Joint position sense	Electro-goniometer was used for proprioception evaluation	30 minutes
Primary	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