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临床试验/NCT01515670
NCT01515670已完成不适用

Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA).

Rigshospitalet, Denmark7 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60,000
试验地点
7
主要终点
Length of hospital stay and reasons for length of hospital stay >4days

研究概览

简要总结

The purpose of the study is to determine the influence of preoperative co-morbidity in relation to increased length of stay and postoperative complications in patients receiving fast-track hip or knee replacement.

详细描述

Preoperative risk assessment is well established and repeatedly demonstrated to be related to adverse postoperative outcomes regarding all organ functions. However, all evidence is based upon conventional care programs and none has been done on fast-track surgery, neither in total hip arthroplasty (THA) or total knee arthroplasty (TKA).

The purpose of this study series is therefore to evaluate the importance of conventional risk factors in an optimised fast-track TKA and THA set-up. These studies will be performed in the Lundbeck Foundation Center for fast-track THA and TKA, based on an established database, but with additional detailed risk information to be included in studies of certain types co-morbidity.

The Lundbeck Foundation Center Database prospectively registers patient characteristics and co-morbidity in all patients receiving hip and knee arthroplasty. This is done using a questionaire and with dedicated staff available to help in case of doubt regarding specific questions. Additional information is collected by scrutinizing the patients medical charts. Completeness of data has been shown to be about 95%.

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

  • Standardized elective fast-track THA or TKA

排除标准

  • Elective THA or TKA not in regular fast-track setup
  • not a Danish citizen

结局指标

主要结局

Length of hospital stay and reasons for length of hospital stay >4days

时间窗: At discharge

Number of nights spend in hospital after day of surgery, including transferral between departments. Any procedure followed by more than 4 days in hospital will have review of discharge papers to determine causes of the "prolonged" admission

Surgically related readmissions

时间窗: 90 days after surgery

Evaluation of any potentially surgery related readmission 90 days after discharge. Readmissions defined as related are defined as: Revision due to prosthesis problems, deep venous thrombosis (DVT), pulmonary embolism (PE) (verified or disproved), stroke/transitory cerebral ischaemia (TCI), possible wound infection (return to operating theatre, treatment with antibiotics only, no treatment), fractures without known trauma, falls, knee manipulation, hip dislocation, cardiac problems (acute myocardial infarction (AMI), any type of arrhythmia), pneumonia, urinary retention (UR), abdominal complications (gastric ulcer, ileus) and sequelae (rehabilitation, opioid side-effects, pain, other conditions related to surgery). Readmissions due to chronic obstructive lung disease (COPD), syncope and urinary tract infection (UTI) ≤ 30 days of primary admission

次要结局

  • Mortality 90 days after surgery(90 days after surgery)

研究者

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

Christoffer Joergensen

Research-fellow

Rigshospitalet, Denmark

研究点 (7)

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