跳至主要内容
临床试验/EUCTR2009-012043-42-GB
EUCTR2009-012043-42-GB进行中(未招募)1 期

The Effect of a Human Surgical Sealant on Range of Motion in Total Knee Replacement - Effect of surgical sealant on range of motion in TKR

Royal Surrey County Hospital NHS Trust0 个研究点目标入组 170 人开始时间: 2011年6月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
170

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion criteria - Primary total knee replacement - Aged 18 years or over; no upper age limit - Male and female participants - Able to provide written informed consent and comply with study procedures
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion criteria - Abnormal clotting screen pre operatively - Taken warfarin within 7 days of the TKR - Known to need warfarin post-operatively - Known bleeding disorders - Complex primary total knee replacement or revision knee replacement - Inflammatory joint disease - Pre operative haemoglobin levels less than 11 g/dL before surgery - Dementia or other significant cognitive impairment - Known anaphylaxis or severe systemic reaction to human blood products - Pregnant or breast feeding - Participation in another clinical trial or planned during the study - Inability to comply or non-compliance with protocol - Inability to consent for themselves due to mental or physcial incapacity - Excessive bleeding during surgery that warrants the use of a surgical sealant (EvicelTM or another) would prevent the subject from being able to participate

研究者

发起方
Royal Surrey County Hospital NHS Trust

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