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/41387916Actively Recruiting
Led by Rigshospitalet, Denmark · Updated on 2024-08-09
80000
Participants Needed
8
Research Sites
104 weeks
Total Duration
R
Rigshospitalet, Denmark
Lead Sponsor
T
The Novo Nordic Foundation
Collaborating Sponsor
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
The Fast-track Centre for Hip and Knee Replacement Database
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
C
Christoffer C Jorgensen, M.D.
H
Henrik Kehlet, M.D.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Luma Mahmoud Issa, Christoffer Calov Jørgensen, Sten Madsbad...
https://pubmed.ncbi.nlm.nih.gov/41387916Luma Issa Mahmoud, Henrik Kehlet, Sten Madsbad...
https://pubmed.ncbi.nlm.nih.gov/40407287Christoffer C Jørgensen, Martin Lindberg-Larsen, Kirill Gromov...
https://pubmed.ncbi.nlm.nih.gov/40404500Luma Mahmoud Issa, Henrik Kehlet, Sten Madsbad...
https://pubmed.ncbi.nlm.nih.gov/38658012