Effects of Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers
Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on the Levels of Inflammation Markers: A Prospective Comparative Study
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.
研究概览
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- end stage knee OA necessitating TKR surgeries
Exclusion Criteria:
- autoimmune diseases, malignancies, previous knee surgery or post-traumatic arthritis
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Navigation TKR group
TKR performed under computer navigation without violating distal femur bone marrow.
|
Traditional over Conventional TKR
|
Conventional TKR group
TKR performed under conventional distal femur cutting juts with violation of distal femur bone marrow.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Concentration of IL-6(pg/mL)
大体时间:24 hours after TKR
|
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
|
24 hours after TKR
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Concentration of IL-10(pg/mL)
大体时间:24 hours after TKR
|
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
|
24 hours after TKR
|
Concentration of TNF-alpha (pg/mL)
大体时间:24 hours after TKR
|
serum level change from baseline 24 hours after TKR , hemovac level 24 hours after TKR
|
24 hours after TKR
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Navigation TKR的临床试验
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Central Finland Hospital DistrictTurku University Hospital; Oulu University Hospital; Kuopio University Hospital; Seinajoki Central... 和其他合作者招聘中
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Corin撤销类风湿关节炎 | 骨关节炎,膝盖 | 膝关节创伤后骨关节炎 | 内翻畸形,未另作分类,膝 | 外翻畸形,未另作分类,膝 | 屈曲畸形,膝关节 | 股骨远端骨折 | 胫骨上端骨折