The Fast-track Centre for Hip and Knee Replacement Database

Study Overview
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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.

Official Title
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The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications

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

Intervention / Treatment
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* Procedure: Day-surgery
* Procedure: High-risk patient
* Procedure: Main Group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Day-surgery group<br>Patients having hip or knee replacement as day-surgery with successful discharge to own home on day of surgery | Procedure: Day-surgery<br>* Standard surgical procedure but with planned discharge on day of surgery<br>|
| High-risk patients<br>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. | Procedure: High-risk patient<br>* Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.<br>|
| Main group<br>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. | Procedure: Main Group<br>* Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| postoperative morbidity | postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery. | 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. | 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 | 90 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Replacement, Knee Replacement, Perioperative Medicine, Enhanced Recovery After Surgery, Perioperative/Postoperative Complications, Ambulatory Surgical Procedures