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临床试验/NCT00736125
NCT00736125已完成不适用

A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study

Kinamed Incorporated1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)

研究概览

简要总结

The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.

详细描述

Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.

The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design

排除标准

  • •Dementia or severe cognitive impairment
  • •Severe visual or hearing impairments
  • •Inability to follow directions or comprehend the English language
  • •Females who are pregnant
  • •Abnormal distal femur geometry
  • •Pre-existing hardware or abnormal bony architecture in the proximal tibia

研究组 & 干预措施

1

Active Comparator

干预措施: pulsatile saline lavage (Device)

2

Active Comparator

干预措施: carbon dioxide lavage (Device)

结局指标

主要结局

The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)

时间窗: During surgery

次要结局

  • Number of Patients With Emboli in the High Category(During surgery)
  • Number of Patients With Delirium During Hospital Stay(First 3 days after surgery)

研究者

发起方
Kinamed Incorporated
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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