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临床试验/NCT03896282
NCT03896282已完成不适用

Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Patients discharged on day of surgery

研究概览

简要总结

The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.

详细描述

Introduction of fast-track total hip arthroplasty (THA) and total knee arthroplasty (TKA) has led to a decrease in length of stay without compromising patient safety and clinical outcome . In recent years outpatient THA and TKA has gained popularity, especially as major focus is placed on reducing cost and increasing efficiency in all medical treatments . Studies have shown outpatient arthroplasty to be feasible both for THA and TKA patients , with up to 70% of unselected patients being potentially eligible for outpatient surgery. Various results are published on success rate of discharged patients on the day of surgery, ranging from 25% to 99% , depending on patient selection and logistic setup. While the majority of published studies utilizes a modern fast-track setup with early mobilization and multimodal pain treatment, the optimal logistic setup remains unknown.

The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with clinical and radiological osteoarthritis of the hip suitable for primary cementless THA and patients with clinical and radiological osteoarthritis of the knee suitable for primary Cruciate Retaining (CR) TKA
  • Age 18-80
  • American Society of Anesthesiologists (ASA) Score (1-2)
  • Interested in and motivated for same day discharge
  • Family or relatives to be present for >24 hours after discharge
  • Able to understand and give consent to the study

排除标准

  • Unable to provide care at own home on day of surgery for >24 hours after discharge

结局指标

主要结局

Patients discharged on day of surgery

时间窗: 12 hours

Success rate of discharge on day of surgery

次要结局

  • Readmissions(3 months)
  • reoperations(3 months)
  • Patient reported outcomes(3 months)

研究者

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

Kirill Gromov

MD, PhD, Ass. professor

Hvidovre University Hospital

研究点 (2)

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