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NCT Number: NCT05613439

The Fast-track Centre for Hip and Knee Replacement Database

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.

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Key information

Conditions

Hip Ambulatory Surgical Procedures Behavior Enhanced Recovery After Surgery Fast-track Surgery Health Behavior Knee Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Perioperative Medicine Perioperative/Postoperative Complications Postoperative Complications Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg University Hospital, Copenhagen, Capital Region, Denmark

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unwilling to provide informed consent

Treatment and study plan

Day-surgery

Procedure

Standard surgical procedure but with planned discharge on day of surgery

High-risk patient

Procedure

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

Main Group

Procedure

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

Primary outcomes

  1. 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.

  2. postoperative morbidity

    Time frame: 90 days postoperatively

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

  3. 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.

  4. 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

Secondary outcomes

  1. Healthcare utilisation in day-surgery

    Time frame: 30 days postoperatively

    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.

Other outcomes

  1. return to work in day-surgery

    Time frame: 30 days postoperatively

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

  2. patient satisfaction and patient reported outcome measures1

    Time frame: Baseline, 90 and 365 days postoperatively

    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)

  3. patient satisfaction and patient reported outcome measures, THA only.

    Time frame: Baseline, 90 and 365 days postoperatively

    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).

  4. patient satisfaction and patient reported outcome measures, TKA only.

    Time frame: Baseline, 90 and 365 days postoperatively

    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).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: FCD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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