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临床试验/NCT02308410
NCT02308410已完成不适用

Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study

Medicort Sports & Orthopedic Care2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2013年10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
99
试验地点
2
主要终点
Knee Injury and Osteoarthritis Score (KOOS) questionnaire

研究概览

简要总结

A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. The purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.

详细描述

In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) >35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled TKA due to osteoarthritis
  • Age between 50 and 75 years
  • Dutch language proficiency
  • Signed informed consent

排除标准

  • Inflammatory arthritis
  • Severe cardiac complaints
  • Severe pulmonary disorders
  • Body Mass Index >35
  • Severe coagulation disorders
  • Hospitalization in the previous two months before surgery

结局指标

主要结局

Knee Injury and Osteoarthritis Score (KOOS) questionnaire

时间窗: 8 weeks

The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.

次要结局

  • Range of Motion (ROM)(Baseline, day 1, day 2, day 3 and 8 weeks)
  • Isometric bilateral strength(Baseline and 8 weeks)
  • VAS questionnaire.(Baseline, day 1, day 2, day 3 and 8 weeks)
  • EQ-5D questionnaire(Baseline, day 1, day 2, day 3 and 8 weeks)

研究者

发起方
Medicort Sports & Orthopedic Care
申办方类型
Other
责任方
Sponsor

研究点 (2)

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