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临床试验/NCT02465684
NCT02465684Unknown不适用

The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial

Medical University Innsbruck0 个研究点目标入组 30 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
cement mantle thickness

研究概览

简要总结

There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome, easy of rehabilitation etc. It is not appropriate to rely on findings from the field of total knee arthroplasty.

It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with regard to component fixation quality, component positioning and sizing, clinical outcome and rehabilitation process.

Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the medial compartment will be considered for participation.

Patients are then randomized for surgery with or without tourniquet. After an anteromedial Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.

The following outcome parameters are assessed: 1)radiographic cement mantle thickness, 2)component position & sizing, 3)diolucencies, 4)score outcome and 5)parameters of early Rehab.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • waiting list for unicondylar knee arthroplasty

排除标准

  • failed upper tibial osteotomy,
  • insufficiency of the collateral or anterior cruciate ligaments,
  • a fixed varus or valgus deformity (not passively correctable) above 15°,
  • a flexion deformity greater than 15° and 5) rheumatoid arthritis. In addition - with regard to the scope of the current study - further exclusion criteria will be
  • intake of medicinal anticoagulation prior to surgery
  • liver dysfunction / coagulation dysfunction
  • peripheral arterial obstructive disease.

结局指标

主要结局

cement mantle thickness

时间窗: 1 week

次要结局

未报告次要终点

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Liebensteiner

Michael Liebensteiner MD, PhD

Medical University Innsbruck

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