Total Knee Arthroplasty and Clinical Findings

Not Applicable

Completed

• Conditions: Pain, Joint; Orthopedic Disorder; Proprioception; Arthropathy of Knee; Radiography
• Interventions: Procedure: Total Knee Arthroplasty

• Registration Number: NCT04481711
• Lead Sponsor: Karadeniz Technical University

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.

Study Timeline

• Study Start: 2018-11-08
• Primary Completion: 2020-02-08
• Study Completion: 2020-05-08
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-22
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Total Knee Arthroplasty	Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty

Primary Outcome Measures

Name	Time	Method
Pain severity	15 minutes	The pain intensity were evaluated by the Visuel Analog Scale.
Valgity angle and amount of malaligment	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	30 minutes	The Western Ontario and McMaster Universities Arthritis Index was used for functional status.
Proinflammatory cytokine level	30 minutes	Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
Joint position sense	30 minutes	Electro-goniometer was used for proprioception evaluation

Trial Locations

Locations (1)

Karadeniz Technical Üniversitesi; 🇹🇷 Trabzon, Türkiye, Turkey