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临床试验/NCT03163888
NCT03163888已完成不适用

Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers: A Prospective Comparative Study

Chang Gung Memorial Hospital0 个研究点目标入组 200 人开始时间: 2000年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
主要终点
Concentration of IL-6(pg/mL)

研究概览

简要总结

Total knee arthroplasty (TKA) is a well-established modality for the treatment of advanced knee osteoarthritis with high satisfaction rate. However, the traditional cutting jigs for distal femur cutting inevitably violates the medullary canal of femoral bone. The process of intramedullary reaming for the insertion of distal femur cutting jigs stimulated the dissipation of marrow emboli that reported lead to increased risk of myocardial infarction or cardiac stress perioperatively. There are emerging refinements aiming to reduce the insult to the medullary canal of the distal femur as well as to improve the prosthetic alignment, such as navigation assisted TKA or robotic surgery.

In addition to better prosthetic alignment, computer-assisted navigation TKAs also mitigate perioperative blood loss and systemic emboli. The publication previously published by the investigators showed that navigation TKAs can lead to lesser extent of elevation of endothelial injury markers than the traditional TKAs. However, the detrimental effects of intramedullary reaming seem to be multi-dimensional and the whole picture has not been elucidated clearly at present.

Previous studies have shown that operative trauma can trigger marked immune responses. Operative procedures can simultaneously stimulate the pro-inflammatory and anti-inflammatory response, with 80% of the leucocyte transcriptome being affected. Most studies of hip or knee surgery found that operation-triggered immune reactions are associated with postoperative recovery, infection, and even mortality.

The navigation TKAs avoid the process of intra-medullary reaming, which is the mandatory part of conventional TKA for the distal femur cutting. The investigators hypothesize that the reaming process may exert substantial inflammatory response, which can be manifested by higher level of inflammatory markers in the serum and hemovac drainage samples obtained from the participants undergoing conventional TKAs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • end stage knee OA necessitating TKR surgeries

排除标准

  • autoimmune diseases, malignancies, previous knee surgery or post-traumatic arthritis

结局指标

主要结局

Concentration of IL-6(pg/mL)

时间窗: 24 hours after TKR

serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR

次要结局

  • Concentration of IL-10(pg/mL)(24 hours after TKR)
  • Concentration of TNF-alpha (pg/mL)(24 hours after TKR)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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