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临床试验/NCT02752581
NCT02752581已完成不适用

Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery

Mert Özcan0 个研究点目标入组 110 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
主要终点
Activity Pain

研究概览

简要总结

The study was designed to investigate efficacy of suction drains in arthroscopic knee surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were randomised, and suction drain was applied to one group, and the other group as the control group without a suction drain.

详细描述

The groups were compared in terms of patellar shock, knee effusion, knee scoring systems, range of motion, loss of labour, hospitalization time. Also different arthroscopic procedures such as meniscectomy, meniscus repair, synovectomy and microfracture were evaluated in terms of need for a suction drain. The controls was at 1st and 15th day, 6th week and 3rd month.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with knee derangement and accepted to enroll to the study

排除标准

  • intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,

结局指标

主要结局

Activity Pain

时间窗: 3 months

Severity of pain was evaluated with Visual Analogue Scale (VAS). VAS is a horizontal line divided into ten equal intervals in which zero represents no pain and 10 represents the worst pain ever felt.

Rest Pain

时间窗: 3 months

Severity of pain was evaluated with Visual Analogue Scale (VAS). VAS is a horizontal line divided into ten equal intervals in which zero represents no pain and 10 represents the worst pain ever felt.

Range of Motion

时间窗: 3 months

Range of motion is measures in terms of angular degrees.

次要结局

  • Lysholm(3 months)
  • International Knee Documentation Committee Score(3 months)
  • hospitalization time(1 month)
  • loss of labour time(1 month)

研究者

发起方
Mert Özcan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mert Özcan

Assoc. Prof.

Trakya University

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