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临床试验/NCT04481711
NCT04481711已完成不适用

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

Karadeniz Technical University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Pain severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study

结局指标

主要结局

Pain severity

时间窗: 15 minutes

The pain intensity were evaluated by the Visuel Analog Scale.

Valgity angle and amount of malaligment

时间窗: 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

时间窗: 30 minutes

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

Proinflammatory cytokine level

时间窗: 30 minutes

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

Joint position sense

时间窗: 30 minutes

Electro-goniometer was used for proprioception evaluation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat EMİRZEOĞLU

Karadeniz Technical University

Karadeniz Technical University

研究点 (2)

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