Actively Recruiting

Age: 18Years +
All Genders
ID05613439

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

Led by Rigshospitalet, Denmark · Updated on 2024-08-09

80000

Participants Needed

8

Research Sites

104 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

T

The Novo Nordic Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a prospective study registry to collect detailed information on patients undergoing fast-track hip and knee replacement surgery in eight dedicated Danish arthroplasty departments across all five health regions in Denmark. The study aims to better understand preoperative patient characteristics, postoperative complications, and functional outcomes, focusing on the feasibility and safety of day-surgery procedures. This research builds upon a previous database and includes the development of a machine-learning algorithm to identify patients at high risk for complications based on preoperative data. Participants are grouped into three categories: those having day-surgery with discharge on the day of operation, high-risk patients who receive additional perioperative care tailored to their comorbidities, and a main fast-track group undergoing standard procedures and discharged upon meeting functional criteria. Data collected includes prescribed medications, frailty scores, pain assessments, and laboratory tests such as hemoglobin and kidney function. Each department follows a standardized fast-track protocol with dedicated staff overseeing registration and follow-up. During the study, researchers collect preoperative information and follow patients postoperatively using electronic medical records and patient questionnaires. Follow-up assessments include complication scoring systems at 7 and 90 days, health-care utilization at 30 days, and return to work questionnaires for day-surgery patients. Nurses, supported by physicians, ensure data accuracy and monitor outcomes to evaluate postoperative morbidity and the success of day-surgery within a socialized health-care system. The study started in September 2022 and will continue through 2027.

CONDITIONS

Brief Title

The Fast-track Centre for Hip and Knee Replacement Database

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Elective hip or knee replacement surgery
  • Surgery for a non-malignant (non-cancerous) condition
  • Danish social security number
  • Willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Unwillingness to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo hip or knee replacement surgery with fast-track protocols, including day-surgery discharge or standard fast-track care based on risk assessment.

1 visit (in-person on surgery day)

Post-operative Follow-up

Duration - Up to 90 days postoperatively

Participants are monitored for postoperative complications, functional outcomes, and healthcare utilization during recovery.

Follow-up visits as scheduled up to 90 days

Trial Site Locations

Total: 8 locations

1

Bispebjerg University Hospital

Copenhagen, Capital Region, Denmark

Actively Recruiting

2

Gentofte University Hospital

Gentofte Municipality, Capital Region, Denmark

Actively Recruiting

3

Hvidovre Hospital

Hvidovre, Capital Region, Denmark, 2650

Actively Recruiting

4

Gødstrup Hospital

Herning, Region of Middle Judland, Denmark

Active, Not Recruiting

5

Aalborg University Hospital, Farsø

Farsø, Region of Northern Judland, Denmark, 9640

Actively Recruiting

6

Lillebaelt Hospital, Vejle

Vejle, Region of Sourthern Denmark, Denmark, 7100

Actively Recruiting

7

Næstved Hospital

Næstved, Region Sjælland, Denmark

Actively Recruiting

8

University Hospital Svendborg

Svendborg, Region Syddanmark, Denmark

Actively Recruiting

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Research Team

C

Christoffer C Jorgensen, M.D.

H

Henrik Kehlet, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Feasibility of a prospective multicenter observational study-is diabetes a risk factor in ERAS joint arthroplasty?

Luma Mahmoud Issa, Christoffer Calov Jørgensen, Sten Madsbad...

https://pubmed.ncbi.nlm.nih.gov/41387916

Perioperative GLP1-RA management and risk of aspiration in patients with diabetes undergoing fast-track hip and knee arthroplasty.

Luma Issa Mahmoud, Henrik Kehlet, Sten Madsbad...

https://pubmed.ncbi.nlm.nih.gov/40407287

Association of non-anaemic iron deficiency with postoperative outcomes after fast-track hip and knee arthroplasty: a prospective cohort study.

Christoffer C Jørgensen, Martin Lindberg-Larsen, Kirill Gromov...

https://pubmed.ncbi.nlm.nih.gov/40404500

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.

Luma Mahmoud Issa, Henrik Kehlet, Sten Madsbad...

https://pubmed.ncbi.nlm.nih.gov/38658012