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临床试验/NCT03559478
NCT03559478Unknown不适用

Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet: a Randomized Double Blind Controlled Trial

Royal Infirmary of Edinburgh2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
24hr Calculated blood loss

研究概览

简要总结

This study compares the use of sharp dissection with diathermy for the approach to a total knee replacement. Half of the patients will be randomly assigned each intervention.

详细描述

The approach to the knee to carry out a total knee replacement (TKR) can either be carried out using a scalpel, sharp dissection, or using an electric current to divide tissue, monopoly electrocautery. Reducing blood loss is important. Blood loss can result in anaemia, which has a number of effects including shortness of breath, chest pain and lethargy. Blood loss into a newly replaced knee can also result in pain and stiffness in the joint. Total knee replacements are routinely carried out with a tourniquet inflated, which reduces the blood flow into to leg during the operation. Diathermy is applied to areas of bleeding to stop them from doing so during operations. With the tourniquet inflated, some areas that would bleed when this was deflated may not be noticed and continue to bleed. Using diathermy for the approach would be expected to reduce this bleeding compared to using a scalpel.

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
Single (Participant)

盲法说明

Patients will be blinded to the intervention as they will be under anaesthetic whilst the procedure is being carried out.

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary knee osteoarthritis requiring TKA (total knee arthroplasty)
  • Planned for cruciate retaining prosthesis without patella resurfacing
  • Patient is able to give informed consent
  • Patient resides locally and will be available for follow up

排除标准

  • Cardiac pacemaker
  • Inflammatory arthropathy
  • Tourniquet contraindicated
  • Thrombophilia/haemoglobinopathy
  • Spinal anaesthetic not possible

研究组 & 干预措施

Treatment Group 1

Active Comparator

Sharp dissection with scalpel plus electrocautery to vessels

干预措施: Sharp dissection with scalpel plus electrocautery to vessels (Procedure)

Treatment Group 2

Active Comparator

Electrocautery for all dissection

干预措施: Electrocautery for all dissection (Procedure)

结局指标

主要结局

24hr Calculated blood loss

时间窗: 1 day

Will be done using the Nadler and Gross formulae

次要结局

  • Haemoglobin drop(1 day)
  • Length of hospital stay(2 weeks)
  • Range of motion 48hrs and 6 weeks(6 weeks)
  • Transfusion requirement(2 days)
  • VAS (Visual Analogue Scale) pain score 24 and 48 hrs(2 days)
  • Improvement in Oxford knee score at 12 months(12 months)
  • Adverse events(12 months)

研究者

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

Chloe Scott

Consultant Trauma and Orthopaedic Surgeon

Royal Infirmary of Edinburgh

研究点 (2)

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