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Clinical Trials/NCT01515670
NCT01515670
Completed
Not Applicable

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

Rigshospitalet, Denmark7 sites in 1 country60,000 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty Complications
Sponsor
Rigshospitalet, Denmark
Enrollment
60000
Locations
7
Primary Endpoint
Length of hospital stay and reasons for length of hospital stay >4days
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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%.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
January 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christoffer Joergensen

Research-fellow

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Standardized elective fast-track THA or TKA

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

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

Study Sites (7)

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