The Fast-track Centre for Hip and Knee Replacement Database
FCD
1 other identifier
observational
80,000
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedAugust 9, 2024
August 1, 2024
3.3 years
October 19, 2022
August 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Healthcare utilisation in day-surgery
30 days postoperatively
Other Outcomes (4)
return to work in day-surgery
30 days postoperatively
patient satisfaction and patient reported outcome measures1
Baseline, 90 and 365 days postoperatively
patient satisfaction and patient reported outcome measures, THA only.
Baseline, 90 and 365 days postoperatively
- +1 more other outcomes
Study Arms (3)
Day-surgery group
Patients having hip or knee replacement as day-surgery with successful discharge to own home 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.
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.
Interventions
Standard surgical procedure but with planned discharge on day of surgery
Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.
Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria
Eligibility Criteria
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.
You may qualify if:
- age \>18 years
- non-malignant surgery
- danish social security number
- elective procedure
You may not qualify if:
- unwilling to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- The Novo Nordic Foundationcollaborator
- Gødstrup Hospitalcollaborator
- Sygehus Lillebaeltcollaborator
- Svendborg Hospitalcollaborator
- University Hospital, Gentofte, Copenhagencollaborator
- Naestved Hospitalcollaborator
- Bispebjerg Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Hvidovre University Hospitalcollaborator
- Region of Southern Denmarkcollaborator
Study Sites (8)
Bispebjerg University Hospital
Copenhagen, Capital Region, Denmark
Gentofte University Hospital
Gentofte Municipality, Capital Region, Denmark
Hvidovre Hospital
Hvidovre, Capital Region, 2650, Denmark
Gødstrup Hospital
Herning, Region of Middle Judland, Denmark
Aalborg University Hospital, Farsø
Farsø, Region of Northern Judland, 9640, Denmark
Lillebaelt Hospital, Vejle
Vejle, Region of Sourthern Denmark, 7100, Denmark
Næstved Hospital
Næstved, Region Sjælland, Denmark
University Hospital Svendborg
Svendborg, Region Syddanmark, Denmark
Related Publications (4)
Issa LM, Jorgensen CC, Madsbad S, Lindberg-Larsen M, Varnum C, Jakobsen T, Andersen MR, Bieder MJ, Overgaard S, Hansen TB, Gromov K, Kehlet H. Feasibility of a prospective multicenter observational study-is diabetes a risk factor in ERAS joint arthroplasty? Pilot Feasibility Stud. 2025 Dec 13. doi: 10.1186/s40814-025-01747-w. Online ahead of print.
PMID: 41387916DERIVEDMahmoud LI, Kehlet H, Madsbad S, Lindberg-Larsen M, Varnum C, Jakobsen T, Andersen MR, Bieder MJ, Overgaard S, Hansen TB, Gromov K, Jorgensen CC. Perioperative GLP1-RA management and risk of aspiration in patients with diabetes undergoing fast-track hip and knee arthroplasty. Dan Med J. 2025 Apr 9;72(5):A09240629. doi: 10.61409/A09240629.
PMID: 40407287DERIVEDJorgensen CC, Lindberg-Larsen M, Gromov K, Varnum C, Bider MJ, Overgaard S, Andersen MR, Hansen TB, Kehlet H. Association of non-anaemic iron deficiency with postoperative outcomes after fast-track hip and knee arthroplasty: a prospective cohort study. Br J Anaesth. 2025 Aug;135(2):322-330. doi: 10.1016/j.bja.2025.03.039. Epub 2025 May 21.
PMID: 40404500DERIVEDIssa LM, Kehlet H, Madsbad S, Lindberg-Larsen M, Varnum C, Jakobsen T, Andersen MR, Bieder MJ, Overgaard S, Hansen TB, Gromov K, Jorgensen CC. Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty. BMJ Open. 2024 Apr 23;14(4):e080232. doi: 10.1136/bmjopen-2023-080232.
PMID: 38658012DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Henrik Kehlet, M.D.
Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Database manager
Study Record Dates
First Submitted
October 19, 2022
First Posted
November 14, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
August 9, 2024
Record last verified: 2024-08