The Fast-track Centre for Hip and Knee Replacement Database

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age >18 years

non-malignant surgery

danish social security number

elective procedure

Disqualifiers

unwilling to provide informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Day-surgery

    Procedure/Surgery

    Standard surgical procedure but with planned discharge on day of surgery

  • High-risk patient

    Procedure/Surgery

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

  • Main Group

    Procedure/Surgery

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

Treatment groups

80,000 Participants
are divided into 3 treatment groups
Group A: Day-surgery group1 intervention
Group B: High-risk patients1 intervention
Group C: Main group1 intervention

Trial outcomes

Primary outcomes

1

Fraction of unselected patients able to undergo day-surgery procedures

The fraction patients eligible for day-surgery who are discharged on day of surgery.

Time frame
7 days postoperatively
2

postoperative morbidity

postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery.

Time frame
90 days postoperatively
3

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.

Time frame
90 days postoperatively
4

postoperative morbidity CCI

Postoperative morbidity resulting in prolonged (\>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index

Time frame
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.

Time frame
30 days postoperatively

Other outcomes

1

return to work in day-surgery

changes in work status and time to return to work in day-surgery procedures

Time frame
30 days postoperatively
2

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)

Time frame
Baseline, 90 and 365 days postoperatively
3

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).

Time frame
Baseline, 90 and 365 days postoperatively
4

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).

Time frame
Baseline, 90 and 365 days postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

The Novo Nordic Foundation

Collaborator

Gødstrup Hospital

Collaborator

Sygehus Lillebaelt

Collaborator

Svendborg Hospital

Collaborator

University Hospital, Gentofte, Copenhagen

Collaborator

Naestved Hospital

Collaborator

Bispebjerg Hospital

Collaborator

Aalborg University Hospital

Collaborator

Hvidovre University Hospital

Collaborator

Region of Southern Denmark

Collaborator