The Fast-track Centre for Hip and Knee Replacement Database

NCT ID: NCT05613439

Last Updated: 2024-08-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

80000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

High-risk patient

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

Intervention Type PROCEDURE

Main Group

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unwilling to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Novo Nordic Foundation

OTHER

Sponsor Role collaborator

Gødstrup Hospital

OTHER

Sponsor Role collaborator

Sygehus Lillebaelt

OTHER

Sponsor Role collaborator

Svendborg Hospital

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Naestved Hospital

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Christoffer Joergensen

Database manager

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Gentofte University Hospital

Gentofte Municipality, Capital Region, Denmark

Site Status RECRUITING

Hvidovre Hospital

Hvidovre, Capital Region, Denmark

Site Status RECRUITING

Gødstrup Hospital

Herning, Region of Middle Judland, Denmark

Site Status ACTIVE_NOT_RECRUITING

Aalborg University Hospital, Farsø

Farsø, Region of Northern Judland, Denmark

Site Status RECRUITING

Lillebaelt Hospital, Vejle

Vejle, Region of Sourthern Denmark, Denmark

Site Status RECRUITING

Næstved Hospital

Næstved, Region Sjælland, Denmark

Site Status RECRUITING

University Hospital Svendborg

Svendborg, Region Syddanmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Christoffer C Jorgensen, M.D.

Role: CONTACT

+48 29 66 59

Henrik Kehlet, M.D.

Role: CONTACT

+45 35 45 35 45

Facility Contacts

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Søren Overgaard, MD

Role: primary

+45 38 63 50 00

Mikkel R Andersen, M.D.

Role: primary

+45 38 67 38 67

Kirill Gromov, M.D.

Role: primary

+45 38 62 38 62

Thomas Jakobsen, M.D.

Role: primary

+45 97 66 00 00

Claus Varnum, M.D.

Role: primary

+45 76 36 20 00

Kim P Sperling, MD

Role: primary

+45 56 51 20 00

Martin Lindberg-Larsen, M.D.

Role: primary

+45 63 20 20 00

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.

Reference Type DERIVED
PMID: 40407287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40404500 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38658012 (View on PubMed)

Related Links

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https://fast-track.health/

The Fast-track Center Homepage

Other Identifiers

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FC-1

Identifier Type: -

Identifier Source: org_study_id

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