HipFCDNCT05613439
The Fast-track Centre for Hip and Knee Replacement Database
An observational study of Hip and Knee, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip, Knee, Fast-track Surgery
- What is being tested?
- Day-surgery, High-risk patient and Main Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 45,000 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Sep 2022to 31 Dec 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- age >18 years
- non-malignant surgery
- danish social security number
- elective procedure
Who cannot join
- unwilling to provide informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Bispebjerg University Hospital
Copenhagen, Capital Region
Aalborg University Hospital, Farsø
Farsø, Region of Northern Judland, 9640
Gentofte University Hospital
Gentofte Municipality, Capital Region
Gødstrup Hospital
Herning, Region of Middle Judland
Hvidovre Hospital
Hvidovre, Capital Region, 2650
Næstved Hospital
Næstved, Region Sjælland
University Hospital Svendborg
Svendborg, Region Syddanmark
Lillebaelt Hospital, Vejle
Vejle, Region of Sourthern Denmark, 7100
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip, Knee, Fast-track Surgery, Enhanced Recovery After Surgery, Perioperative Medicine, Ambulatory Surgical Procedures
- Being tested
- Day-surgery, High-risk patient, Main Group
- Keywords
- Hip Replacement, Knee Replacement, Perioperative Medicine, Enhanced Recovery After Surgery, Perioperative/Postoperative Complications, Ambulatory Surgical Procedures
- Medical subject headings
- Postoperative Complications, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day-surgeryProcedure or surgery
Standard surgical procedure but with planned discharge on day of surgery
High-risk patientProcedure or surgery
Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.
Main GroupProcedure or surgery
Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria
| Study group | Role | What they receive |
|---|---|---|
| Day-surgery group | Patients having hip or knee replacement as day-surgery with successful discharge to own home on day of surgery Receives: Procedure: Day-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. Receives: Procedure: High-risk patient | |
| 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. Receives: Procedure: Main Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of unselected patients able to undergo day-surgery procedures
The fraction patients eligible for day-surgery who are discharged on day of surgery.
Measured: 7 days postoperatively
postoperative morbidity
postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery.
Measured: 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.
Measured: 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
Measured: 90 days postoperatively
Secondary outcomes (1)
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.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HipStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, Gødstrup Hospital, Sygehus Lillebaelt, Svendborg Hospital, University Hospital, Gentofte, Copenhagen, Naestved Hospital, Bispebjerg Hospital, Aalborg University Hospital, Hvidovre University Hospital, Region of Southern Denmark
- Responsible party
- Principal investigator, Christoffer Joergensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik Kehlet, M.D., Study chair, Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613439
- Sponsor's protocol ID
- FC-1
- Acronym
- FCD
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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;12(1):10. doi: 10.1186/s40814-025-01747-w.
PubMed 41387916Mahmoud 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.
PubMed 40407287Jorgensen 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.
PubMed 40404500Issa 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.
PubMed 38658012
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications
- ClinicalTrials.gov ID
- NCT05613439
- Acronym / sponsor ID
- FCD / FC-1
- Conditions
- Hip, Knee, Fast-track Surgery, Enhanced Recovery After Surgery, Perioperative Medicine, Ambulatory Surgical Procedures
- Keywords
- Hip Replacement, Knee Replacement, Perioperative Medicine, Enhanced Recovery After Surgery, Perioperative/Postoperative Complications, Ambulatory Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45,000 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, Gødstrup Hospital, Sygehus Lillebaelt, Svendborg Hospital, University Hospital, Gentofte, Copenhagen, Naestved Hospital, Bispebjerg Hospital, Aalborg University Hospital, Hvidovre University Hospital, Region of Southern Denmark
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day-surgery group | – | Procedure: Day-surgeryPatients having hip or knee replacement as day-surgery with successful discharge to own home on day of surgery |
| High-risk patients | – | Procedure: High-risk patientPatients 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 | – | Procedure: Main GroupPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age >18 years
- non-malignant surgery
- danish social security number
- elective procedure
Key exclusion criteria (1 listed)
- unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day-surgeryStandard surgical procedure but with planned discharge on day of surgery | Procedure or surgery | Day-surgery group |
| High-risk patientStandard fast-track procedure but with additional perioperative measures dependent on risk-profile. | Procedure or surgery | High-risk patients |
| Main GroupStandard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria | Procedure or surgery | Main group |
Primary outcome
Fraction of unselected patients able to undergo day-surgery procedures
Time frame: 7 days postoperatively
The fraction patients eligible for day-surgery who are discharged on day of surgery.
postoperative morbidity
Time frame: 90 days postoperatively
postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery.
postoperative morbidity Clavien-Dindo
Time frame: 90 days postoperatively
Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Clavien-Dindo index.
postoperative morbidity CCI
Time frame: 90 days postoperatively
Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index
1 secondary outcome
Healthcare utilisation in day-surgery
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Derived from this study: PubMed 41387916Issa 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;12(1):10. doi: 10.1186/s40814-025-01747-w.
- Derived from this study: PubMed 40407287Mahmoud 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.
- Derived from this study: PubMed 40404500Jorgensen 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.
- Derived from this study: PubMed 38658012Issa 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.
- The Fast-track Center HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Kehlet, M.D. study chair
Section for Surgical Pathophysiology, Rigshospitalet, University of Copenhagen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip and Knee, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of unselected patients able to undergo day-surgery procedures (time frame: 7 days postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613439, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.