About this trial
This is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 Danish dedicated arthroplasty departments from all five health regions in Denmark. The registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. Follow-up is based on electronical medical records by dedicated nurses with physician backup and includes Clavien-Dindo and Comprehensive Complication Index scoring. All patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. Finally, a machine-learning algorithm for identification of "high-risk" patients based on he preoperative data is included.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age >18 years
non-malignant surgery
danish social security number
elective procedure
Disqualifiers
unwilling to provide informed consent
Trial population
The participating dedicated arthroplasty departments are placed in either large university or regional hospitals. The departments cover all five healthcare regions in Denmark and are estimated to contribute with about 40% of the annual hip and knee replacements in Denmark. Thus, the population is representative of the general Danish arthroplasty population.
Trial design
Cohort
Prospective
Treatments tested in this trial
Day-surgery
Procedure/SurgeryStandard surgical procedure but with planned discharge on day of surgery
High-risk patient
Procedure/SurgeryStandard fast-track procedure but with additional perioperative measures dependent on risk-profile.
Main Group
Procedure/SurgeryStandard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria
Treatment groups
Trial outcomes
Primary outcomes
Fraction of unselected patients able to undergo day-surgery procedures
The fraction patients eligible for day-surgery who are discharged on day of surgery.
postoperative morbidity
postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery.
postoperative morbidity Clavien-Dindo
Postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Clavien-Dindo index.
postoperative morbidity CCI
Postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index
Secondary outcomes
Healthcare utilisation in day-surgery
Registration of emergency room visits, visits to general practitioners and use of medical emergency services within 30 days after having hip or knee replacement as day-surgery procedure.
Other outcomes
return to work in day-surgery
changes in work status and time to return to work in day-surgery procedures
patient satisfaction and patient reported outcome measures1
collection of data on patient satisfaction and function after surgery using the EQ-5D-5L (score from 0-100 with increasing score indicating better health)
patient satisfaction and patient reported outcome measures, THA only.
collection of data on patient satisfaction and function after surgery using the Oxford Hip Score (range from 0-48 with increasing score indicating better function).
patient satisfaction and patient reported outcome measures, TKA only.
collection of data on patient satisfaction and function after surgery using the Oxford Knee score (range from 0-48 with increasing score indicating better function).
Sponsors and contacts
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Rigshospitalet, Denmark
Lead sponsor
The Novo Nordic Foundation
Collaborator
Gødstrup Hospital
Collaborator
Sygehus Lillebaelt
Collaborator
Svendborg Hospital
Collaborator
University Hospital, Gentofte, Copenhagen
Collaborator
Naestved Hospital
Collaborator
Bispebjerg Hospital
Collaborator
Aalborg University Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Region of Southern Denmark
Collaborator