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临床试验/NCT04487535
NCT04487535已完成不适用

The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings

Hacettepe University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年12月1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
29
试验地点
2
主要终点
Pain intensty

研究概览

简要总结

Serum cytokines was assosiated with symptoms and progression of osteoartritis. It is unknown whether these cytokines have a predictive role on severity of symptoms after total knee arthroplasty (TKA) or not. The aim of this study is to investigate the relationships between the preoperative serum cytokine level (SCL) and lenght of stay in hospital, postoperative pain intensity, functional status, joint position sense and X ray.

Grade 4 osteoartritis degeneration who intern the hospital for total knee arthroplasty surgery. Serum Cytokine Levels (IL-6, TNFα, IL-1β) will be assessed before surgery. Pain intensity at rest/activity and valgite angle will be evaluated before surgery, postoperative 72 hour and postoperative 6 weeks. Functional status and joint position sense will be assessed before surgery and 6 weeks after surgery. Lenght of stay in hospital (LOS) will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 45-75
  • were scheduled for unilateral or bilateral TKA
  • were diagnosed of OA with a severity Grade 4 according to the Kellgren-Lawrence (KL) classification.

排除标准

  • neuropathic pain
  • presurgery for same lower extremity
  • vascular disease
  • any chronic disease related to kidney, heart, liver
  • chronic inflammatory disease

结局指标

主要结局

Pain intensty

时间窗: pain intensity will be evaluated. It will determined pain intensity alteration from 2 weeks before surgery and at 72 hours and at 6 weeks following surgery

Rest and activity pain intensity will be evaluated by using 100 mm vertical line Visual Anolog Scale (VAS). Zero meet no pain, 10 unbearable pain

次要结局

  • Functional Status(Functional status will be assessed before surgery and 6 weeks after surgery)
  • X-Ray(X-ray evaluated before surgery, 72 hour after surgery and 6 weeks ater surgery)
  • Joint Position Sense(It will be evaluated before surgery and 6 weeks after surgery)
  • Serum Cytokine Level(Venous blood sample was collected 2 weeks before surgery)

研究者

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

Kübra Canli

Karadeniz Technical University

Karadeniz Technical University

研究点 (2)

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