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临床试验/NCT04100837
NCT04100837已完成不适用

Effect of Multiple Instrumentation in Transportal and Transtibial Techniques for ACL Reconstruction Regarding Bacterial Contamination: A Randomized Control Study

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月15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
80
试验地点
1
主要终点
Assessment the concentration of contamination in ACL operation.

研究概览

简要总结

To determine the Effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study

详细描述

Infection is a catastrophic and one of the most dreaded complications in orthopaedic surgery. Several measures have been undertaken to reduce the risk of infection, one of which is the use of systemic prophylactic antibiotics.

The purpose of this study is to determine the effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction . About Eighty consecutive patients having surgical indication for ACL-R will be included, the cases will be divided into two groups, 35 cases will undergo for the transtibial technique and the other 45 cases will undergo for the transportal technique. After preparation, swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) and in transtibial technique before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Isolated ACL Injury.
  • •Non deformed knee.

排除标准

  • •Associated knee injury (eg. PCL).
  • •Deformed knee ( eg. genu varus , genu valgus more than 4 degree )
  • •patient with medical history of being immune compromized patient eg,DM

结局指标

主要结局

Assessment the concentration of contamination in ACL operation.

时间窗: Through study completion, an average of 1 year.

Effect of instrumentation on contamination of the operation,swabs will be obtained intraoperative for cultures.

次要结局

未报告次要终点

研究者

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

Kerollos Zaghloul Thabet

Orthopedics & traumatology doctor

Assiut University

研究点 (1)

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