The Fast-track Centre for Hip and Knee Replacement Database
NCT ID: NCT05613439
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80000 participants
OBSERVATIONAL
2022-09-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Day-surgery group
Patients having hip or knee replacement as day-surgery with successful discharge to own home on day of surgery
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.
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.
Main Group
Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria
Interventions
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Day-surgery
Standard surgical procedure but with planned discharge on day of surgery
High-risk patient
Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.
Main Group
Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria
Eligibility Criteria
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Inclusion Criteria
* non-malignant surgery
* danish social security number
* elective procedure
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Novo Nordic Foundation
OTHER
Gødstrup Hospital
OTHER
Sygehus Lillebaelt
OTHER
Svendborg Hospital
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Naestved Hospital
OTHER
Bispebjerg Hospital
OTHER
Aalborg University Hospital
OTHER
Hvidovre University Hospital
OTHER
Region of Southern Denmark
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Christoffer Joergensen
Database manager
Principal Investigators
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Henrik Kehlet, M.D.
Role: STUDY_CHAIR
Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen
Locations
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Bispebjerg University Hospital
Copenhagen, Capital Region, Denmark
Gentofte University Hospital
Gentofte Municipality, Capital Region, Denmark
Hvidovre Hospital
Hvidovre, Capital Region, Denmark
Gødstrup Hospital
Herning, Region of Middle Judland, Denmark
Aalborg University Hospital, Farsø
Farsø, Region of Northern Judland, Denmark
Lillebaelt Hospital, Vejle
Vejle, Region of Sourthern Denmark, Denmark
Næstved Hospital
Næstved, Region Sjælland, Denmark
University Hospital Svendborg
Svendborg, Region Syddanmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Mahmoud 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.
Jorgensen 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.
Issa 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.
Related Links
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The Fast-track Center Homepage
Other Identifiers
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FC-1
Identifier Type: -
Identifier Source: org_study_id
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