跳至主要内容
临床试验/NCT03667339
NCT03667339终止不适用

Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Cumulative lenght of stay

研究概览

简要总结

The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral primary total hip arthroplasty for hip osteoarthritis, primary or secondary osteoarthritis (dysplasia or post-traumatic) or osteonecrosis
  • Good enough understanding of outpatient management and patient adherence to post-operative instructions
  • Sufficient patient complicance to medical orders
  • Living and hygiene conditions, at least, equivalent to the ones the hospital provides
  • To be of age
  • Non opposition to the protocole participation
  • Outpatients group :
  • Patient schedulded to undergo outpatient THA
  • Inpatients group :
  • Patient schedulded to undergo inpatient THA because of not fiting the following items :
  • Less than an hour distance of a Health Center that provides appropriate care with regard to the surgery
  • Rapid access to a phone
  • Designated driver and caretaker available (at least the first night after discharge from the hospital) after the procedure Or turning down outpatient THA

排除标准

  • Anaesthetic point of view :
  • ASA physical status ≥ 3 and : unstabilize disease with appropriate treatment or lack of preoperative mutual agreement between anesthesiologist and surgeon or not inconsiderable interaction between the operation and the disease or its treatment
  • Pre-operative Hb < 12 (♀) < 13 (♂) g/L (NB : no Hb control before discharge except if excessive blood loss ; Hb < 10g/L contraindicates outpatient surgery)
  • Opioid chronic pre-operative therapy or opioid addiction
  • Surgical point of view :
  • Ambulatory pre-operative status requiring use of two crutches or walking frame / distance walked < 30 m
  • THA procedure for femoral neck fracture requiring
  • Additional operative technic needed
  • Adult safeguarding.
  • Exclusion criteria applies to all in and outpatients.

结局指标

主要结局

Cumulative lenght of stay

时间窗: 45 days before surgery

Cumulative lenght of stay ( ie : the sum of the days of hospitalization corresponding to the initial hospitalization and readmissions if there are any)

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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