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

Completed

• Conditions: Arthroplasty Complications; Co-morbidity; Postoperative Morbidity

• Registration Number: NCT01515670
• Lead Sponsor: Rigshospitalet, Denmark

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%.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-20
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of hospital stay and reasons for length of hospital stay >4days	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	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 Outcome Measures

Name	Time	Method
Mortality 90 days after surgery	90 days after surgery	Evaluation of all deaths 90 days after surgery

Trial Locations

Locations (7)

Holstebro Regionalhospital; 🇩🇰 Holstebro, Judland, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Seeland, Denmark

Gentofte University Hospital; 🇩🇰 Gentofte, Denmark

Vejle Hospital; 🇩🇰 Vejle, Judland, Denmark

Himmerland Hospital; 🇩🇰 Farsø, Judland, Denmark

Næstved Hospital; 🇩🇰 Næstved, Denmark

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark