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The Fast-track Centre for Hip and Knee Replacement Database

The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05613439
Acronym
FCD
Enrollment
45000
Registered
2022-11-14
Start date
2022-09-01
Completion date
2025-12-31
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgical Procedures, Enhanced Recovery After Surgery, Fast-track Surgery, Hip, Knee, Patient Satisfaction, Perioperative Medicine, Perioperative/Postoperative Complications

Keywords

Hip Replacement, Knee Replacement, Perioperative Medicine, Enhanced Recovery After Surgery, Perioperative/Postoperative Complications, Ambulatory Surgical Procedures

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.

Interventions

PROCEDUREDay-surgery

Standard surgical procedure but with planned discharge on day of surgery

PROCEDUREHigh-risk patient

Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.

PROCEDUREMain Group

Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER
The Novo Nordic Foundation
CollaboratorOTHER
Gødstrup Hospital
CollaboratorOTHER
Sygehus Lillebaelt
CollaboratorOTHER
Svendborg Hospital
CollaboratorOTHER
University Hospital, Gentofte, Copenhagen
CollaboratorOTHER
Naestved Hospital
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Region of Southern Denmark
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* unwilling to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Fraction of unselected patients able to undergo day-surgery procedures7 days postoperativelyThe fraction patients eligible for day-surgery who are discharged on day of surgery.
postoperative morbidity90 days postoperativelypostoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery.
postoperative morbidity Clavien-Dindo90 days postoperativelyPostoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Clavien-Dindo index.
postoperative morbidity CCI90 days postoperativelyPostoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index

Secondary

MeasureTime frameDescription
Healthcare utilisation in day-surgery30 days postoperativelyRegistration 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.

Countries

Denmark

Contacts

STUDY_CHAIRHenrik Kehlet, M.D.

Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026