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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05613439
Other study ID # FC-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2027

Study information

Verified date May 2024
Source Rigshospitalet, Denmark
Contact Christoffer C Jorgensen, M.D.
Phone +48 29 66 59
Email christoffer.calov.joergensen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 years - non-malignant surgery - danish social security number - elective procedure Exclusion Criteria: - unwilling to provide informed consent

Study Design


Intervention

Procedure:
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

Locations

Country Name City State
Denmark Bispebjerg University Hospital Copenhagen Capital Region
Denmark Aalborg University Hospital, Farsø Farsø Region Of Northern Judland
Denmark Gentofte University Hospital Gentofte Capital Region
Denmark Gødstrup Hospital Herning Region Of Middle Judland
Denmark Hvidovre Hospital Hvidovre Capital Region
Denmark Næstved Hospital Næstved Region Seeland
Denmark University Hospital Svendborg Svendborg Region Of Southern Denmark
Denmark Lillebaelt Hospital, Vejle Vejle Region Of Sourthern Denmark

Sponsors (11)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Aalborg University Hospital, Bispebjerg Hospital, Gødstrup Hospital, Hvidovre University Hospital, Naestved Hospital, Region of Southern Denmark, Svendborg Hospital, Sygehus Lillebaelt, The Novo Nordic Foundation, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other return to work in day-surgery changes in work status and time to return to work in day-surgery procedures 30 days postoperatively
Other 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
Other 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
Other 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
Primary 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
Primary postoperative morbidity postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery. 90 days postoperatively
Primary 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
Primary 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 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
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