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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04481711
Enrollment
51
Registered
2020-07-22
Start date
2018-11-08
Completion date
2020-05-08
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Orthopedic Disorder, Pain, Joint, Proprioception, Radiography

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.

Interventions

PROCEDURETotal 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.

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proinflammatory cytokine level30 minutesSystemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
Pain severity15 minutesThe pain intensity were evaluated by the Visuel Analog Scale.
Functional status30 minutesThe Western Ontario and McMaster Universities Arthritis Index was used for functional status.
Joint position sense30 minutesElectro-goniometer was used for proprioception evaluation
Valgity angle and amount of malaligment30 minutesIn this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026