Clinical trial NCT04481711: Total Knee Arthroplasty and Clinical Findings
Official title: Investigation of the Effect of Total Knee Arthroplasty on Proinflammatory Cytokine Level, Pain Severity, Functional Status, Joint Position Sense and Radiographic Findings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Arthropathy of Knee
Pain, Joint
Proprioception
Radiography
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proinflammatory cytokine level
timeFrame: 30 minutes
measure: Pain severity
timeFrame: 15 minutes
measure: Functional status
timeFrame: 30 minutes
measure: Joint position sense
timeFrame: 30 minutes
measure: Valgity angle and amount of malaligment
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical Üniversitesi
state: Türkiye
Study officials:
affiliation: Karadeniz Technical University
name: Murat Emirzeoğlu
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: Arzu Erden
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Kübra Canlı
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: Serap Özer Yaman
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: İbrahim Pekşen
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: Osman Aynacı
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: Süleyman Caner Karahan
role: STUDY_CHAIR
References: