Clinical trial NCT05613439: The Fast-track Centre for Hip and Knee Replacement Database
Official title: The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip
Knee
Fast-track Surgery
Enhanced Recovery After Surgery
Perioperative Medicine
Ambulatory Surgical Procedures
Perioperative/Postoperative Complications
Patient Satisfaction
Keywords: Hip Replacement
Knee Replacement
Perioperative Medicine
Enhanced Recovery After Surgery
Perioperative/Postoperative Complications
Ambulatory Surgical Procedures
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
name: Gødstrup Hospital
name: Sygehus Lillebaelt
name: Svendborg Hospital
name: University Hospital, Gentofte, Copenhagen
name: Naestved Hospital
name: Bispebjerg Hospital
name: Aalborg University Hospital
name: Hvidovre University Hospital
name: Region of Southern Denmark
First posted: 2022-11-14
Enrollment: 80000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: The study registry is intended for further detailed research on postoperative morbidity, feasibility and safety of day surgery and functional outcomes after fast-track hip and knee replacement in 8 dedicated Danish arthroplasty wards across all five health care regions in Denmark. The work is a continuation of the Lundbeck Foundation Centre Database on Hip and Knee Replacement also registered in ClinicalTrials but ceased enrolling in august 2017.

The aim of the registry is to provide standardized and comprehensive information on preoperative patient characteristics and postoperative complications, patient reported outcome measures and health-care utilization in fast-track hip and knee replacement within a socialized health-care system. Each department have dedicated research personel assuring registration and follow-up supervised by a datamanager, and with database-support from the Danish health Region of Southern Denmark.

All departments have similar established fast-track protocols as standard of care, but with focus on dividing patients into day-surgery, main fast-track group and high-risk cohorts.

Preoperative data includes information on prescribed medication, Clinical Frailty Score using CFS v.1, evaluation of Pain Catastrophizing Scale as well as laboratory testing of hemoglobin, kidney function, Hb1Ac in diabetics and C-reactive protein level. On the basis of the collected preoperative data a machine-learning algorithm for identifying the "high-risk" patients is being refined and with planned induction in the database.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* non-malignant surgery
* danish social security number
* elective procedure

Exclusion Criteria:

* unwilling to provide informed consent

Primary outcomes:
measure: Fraction of unselected patients able to undergo day-surgery procedures
timeFrame: 7 days postoperatively
measure: postoperative morbidity
timeFrame: 90 days postoperatively
measure: postoperative morbidity Clavien-Dindo
timeFrame: 90 days postoperatively
measure: postoperative morbidity CCI
timeFrame: 90 days postoperatively
Secondary outcomes:
measure: Healthcare utilisation in day-surgery
timeFrame: 30 days postoperatively
Other outcomes:
measure: return to work in day-surgery
timeFrame: 30 days postoperatively
measure: patient satisfaction and patient reported outcome measures1
timeFrame: Baseline, 90 and 365 days postoperatively
measure: patient satisfaction and patient reported outcome measures, THA only.
timeFrame: Baseline, 90 and 365 days postoperatively
measure: patient satisfaction and patient reported outcome measures, TKA only.
timeFrame: Baseline, 90 and 365 days postoperatively
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
state: Capital Region
city: Gentofte
country: Denmark
facility: Gentofte University Hospital
state: Capital Region
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Capital Region
city: Herning
country: Denmark
facility: Gødstrup Hospital
state: Region Of Middle Judland
city: Farsø
country: Denmark
facility: Aalborg University Hospital, Farsø
state: Region Of Northern Judland
city: Vejle
country: Denmark
facility: Lillebaelt Hospital, Vejle
state: Region Of Sourthern Denmark
city: Svendborg
country: Denmark
facility: University Hospital Svendborg
state: Region Of Southern Denmark
city: Næstved
country: Denmark
facility: Næstved Hospital
state: Region Seeland
Study officials:
affiliation: Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen
name: Henrik Kehlet, M.D.
role: STUDY_CHAIR
References: