The Fast-track Centre for Hip and Knee Replacement Database (FCD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Satisfaction; Hip; Knee; Fast-track Surgery; Enhanced Recovery After Surgery; Perioperative Medicine; Ambulatory Surgical Procedures; Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: Day-surgery; Procedure: High-risk patient; Procedure: Main Group

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.

• Study Type: Observational
• Enrollment (Estimated): 80000

Contacts and Locations

• Study Contact: Name: Christoffer C Jorgensen, M.D.; Phone Number: +48 29 66 59; Email: christoffer.calov.joergensen@regionh.dk
• Study Contact Backup: Name: Henrik Kehlet, M.D.; Phone Number: +45 35 45 35 45; Email: henrik.kehlet@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark
      • Recruiting
      • Bispebjerg University Hospital
      • Contact: Søren Overgaard, MD; Phone Number: +45 38 63 50 00; Email: soeren.overgaard@regionh.dk
      • Principal Investigator: Søren Overgaard
    • Gentofte, Capital Region, Denmark
      • Recruiting
      • Gentofte University Hospital
      • Contact: Mikkel R Andersen, M.D.; Phone Number: +45 38 67 38 67; Email: mikkel.rathsach.andersen@regionh.dk
      • Principal Investigator: Mikkel Rathsach, MD
    • Hvidovre, Capital Region, Denmark, 2650
      • Recruiting
      • Hvidovre Hospital
      • Contact: Kirill Gromov, M.D.; Phone Number: +45 38 62 38 62; Email: Kirill.Gromov@regionh.dk
      • Principal Investigator: Kirill Gromov, M.D
  • Region Of Middle Judland
    • Herning, Region Of Middle Judland, Denmark
      • Active, not recruiting
      • Gødstrup Hospital
  • Region Of Northern Judland
    • Farsø, Region Of Northern Judland, Denmark, 9640
      • Recruiting
      • Aalborg University Hospital, Farsø
      • Contact: Thomas Jakobsen, M.D.; Phone Number: +45 97 66 00 00; Email: thomas.jakobsen@rn.dk
      • Principal Investigator: Thomas Jakobsen, M.D
  • Region Of Sourthern Denmark
    • Vejle, Region Of Sourthern Denmark, Denmark, 7100
      • Recruiting
      • Lillebaelt Hospital, Vejle
      • Contact: Claus Varnum, M.D.; Phone Number: +45 76 36 20 00; Email: Claus.Varnum@rsyd.dk
      • Principal Investigator: Claus Varnum, MD
  • Region Of Southern Denmark
    • Svendborg, Region Of Southern Denmark, Denmark
      • Recruiting
      • University Hospital Svendborg
      • Contact: Martin Lindberg-Larsen, M.D.; Phone Number: +45 63 20 20 00; Email: Martin.Lindberg-Larsen@rsyd.dk
      • Principal Investigator: Martin Lindberg-Larsen, M.D.
  • Region Seeland
    • Næstved, Region Seeland, Denmark
      • Recruiting
      • Næstved Hospital
      • Contact: Kim P Sperling, MD; Phone Number: +45 56 51 20 00; Email: kpsp@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Day-surgery group; Patients having hip or knee replacement as day-surgery with successful discharge to own home on day of surgery	Procedure: Day-surgery; Standard surgical procedure but with planned discharge on day of surgery
High-risk patients; Patients evaluated to be at increased risk of postoperative complications. These patients will receive relevant additional attention based on type of comorbidity. I.e. preoperative evaluation of iron status and i.v. iron treatment in case of preoperative anaemia, increased focus on avoidance of NSAIDs and adequate fluid therapy in patients with renal disease etc.	Procedure: High-risk patient; Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.
Main group; Patients who are not scheduled for day-surgery and without comorbidities qualifying as "high-risk". These patients go through a standard fast-track procedure with discharge to own home when fulfilling functional discharge criteria.	Procedure: Main Group; Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of unselected patients able to undergo day-surgery procedures	The fraction patients eligible for day-surgery who are discharged on day of surgery.	7 days postoperatively
postoperative morbidity	postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery.	90 days postoperatively
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.	90 days postoperatively
postoperative morbidity CCI	Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index	90 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
return to work in day-surgery	changes in work status and time to return to work in day-surgery procedures	30 days postoperatively
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)	Baseline, 90 and 365 days postoperatively
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).	Baseline, 90 and 365 days postoperatively
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).	Baseline, 90 and 365 days postoperatively

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Hvidovre University Hospital; Bispebjerg Hospital; The Novo Nordic Foundation; Aalborg University Hospital; University Hospital, Gentofte, Copenhagen; Gødstrup Hospital; Sygehus Lillebaelt; Svendborg Hospital; Naestved Hospital; Region of Southern Denmark
• Investigators: Study Chair: Henrik Kehlet, M.D., Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen

Publications and helpful links

Helpful Links

• The Fast-track Center Homepage

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ambulatory Surgical Procedures; Enhanced Recovery After Surgery; Hip Replacement; Knee Replacement; Perioperative Medicine; Perioperative/Postoperative Complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: FC-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No