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临床试验/NCT01891266
NCT01891266Unknown不适用

Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).

研究概览

简要总结

Background:

Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality.

Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function.

It is, however, possible to perform the operation without the use of the tourniquet.

Aim and hypothesis:

The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption.

Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation.

H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet.

Methods:

80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.

The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied

Impact of the project:

The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.

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, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
  • Patients who can tolerate spinal anesthesia

排除标准

  • Patients with rheumatoid arthritis.
  • Patients with BMI >
  • History of major knee operations.
  • Malignancy.
  • Known muscle disease.
  • History of deep vain thrombosis (DVT), or other blood coagulation disorders.
  • Symptomatic bilateral OA, with planned surgery of the contra lateral knee within a year.

结局指标

主要结局

Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).

时间窗: Endpoint 3 months

Further assessments: Baseline, 14 days and a 6 and 12 months follow up. KOOS is a patient-reported outcome measure with good evidence of reliability, validity and responsiveness in different population with varying pathologies, injury durations, and activity levels (http://www.koos.nu).

次要结局

  • Change in the Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up)
  • Global perceived effect (GPE) score(3 months (endpoint) and a 6 and 12 months follow up)
  • Change in physical performance (battery).(Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up)

研究者

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

Rasmus Lohmann-Jensen, MSc

MSc

University of Southern Denmark

研究点 (2)

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