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临床试验/NCT01832272
NCT01832272Unknown4 期

The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
4 期
入组人数
174
试验地点
2
主要终点
Operation time

研究概览

简要总结

This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.

详细描述

Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of primary osteoarthritis of the knee
  • Scheduled for elective total knee arthroplasty
  • Written signed consent

排除标准

  • Revision TKA
  • Diagnosis other than primary osteoarthritis
  • Intra-articular indwelling drainage
  • Refusing participate

结局指标

主要结局

Operation time

时间窗: from skin incision to wound closure

Total time between initial skin incision and wound closure

次要结局

  • Tourniquet time(total sum of time between inflation and deflation of tourniquet)
  • Difficulty of the operation(from skin incision to wound closure)
  • Incidence of transfusion(within 2weeks after surgery)
  • Wound complications(on the 2nd and 14th day after surgery)
  • Thigh complications(within 2 weeks)
  • Venous thromboembolism(within 2 weeks)
  • Postoperative pain (VAS)(on the 2nd and 5th day after surgery.)
  • More painful site(on the 2nd and 5th day after surgery)
  • More painful side in SBTKA(on the 2nd and 5th day after surgery.)
  • Amount of drainage(Until the drainage removal, average of 1 to 2 days after surgery)
  • Hemoglobin drop on the 2nd day after surgery(On the 2nd day after surgery)
  • Hemoglobin drop on the 5th day after surgery(On the 5th day after surgery)

研究者

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

Tae Kyun Kim

Direcor, Joint reconstruction center, SNUBH

Seoul National University Hospital

研究点 (2)

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