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, Martin Lindberg-Larsen, Claus Varnum, Thomas Jakobsen, Mikkel Rathsach Andersen, Manuel Josef Bieder, Søren Overgaard, Torben Bæk Hansen, Kirill Gromov, Christoffer Calov Jørgensen

*Corresponding author for this work

Abstract

INTRODUCTION: Perioperative glycaemic control is important. However, the complexity of guidelines for perioperative diabetes management is complicated due to different and novel antihyperglycaemic medications, limited procedure-specific data and lack of data from implemented fast-track regimens which otherwise are known to reduce morbidity and glucose homeostasis disturbances. Consequently, outcome in patients with diabetes mellitus (DM) after surgery and the influence of perioperative diabetes management on postoperative recovery remains poorly understood.

METHODS AND ANALYSIS: A prospective observational multicentre study involving 8 arthroplasty centres across Denmark with a documented implemented fast-track programme (median length of hospitalisation (LOS) 1 day). We will collect detailed perioperative data including preoperative haemoglobin A1c and antidiabetic treatment in 1400 unselected consecutive patients with DM undergoing hip and knee arthroplasty from September 2022 to December 2025, enrolled after consent. Follow-up duration is 90 days after surgery. The primary outcome is the proportion of patients with DM with LOS >4 days and 90-day readmission rate after fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). The secondary outcome is the association between perioperative diabetes treatment and LOS >2 days, 90-day readmission rate, other patient demographics and Comprehensive Complication Index for patients with DM after THA/TKA/UKA in a fast-track regimen.

ETHICS AND DISSEMINATION: The study will follow the principles of the Declaration of Helsinki and ICH-Good Clinical Practice guideline. Ethical approval was not necessary as this is a non-interventional observational study on current practice. The trial is registered in the Region of Southern Denmark and on ClinicalTrials.gov. The main results and all substudies of this trial will be published in peer-reviewed international medical journals.

TRIAL REGISTRATION NUMBER: NCT05613439.

Original languageEnglish
Article numbere080232
JournalBMJ Open
Volume14
Issue number4
Pages (from-to)e080232
ISSN2044-6055
DOIs
Publication statusPublished - 23 Apr 2024

Keywords

  • Humans
  • Prospective Studies
  • Arthroplasty, Replacement, Hip
  • Arthroplasty, Replacement, Knee
  • Risk Factors
  • Denmark
  • Diabetes Mellitus
  • Length of Stay/statistics & numerical data
  • Glycated Hemoglobin/analysis
  • Postoperative Complications
  • Patient Readmission/statistics & numerical data
  • Hypoglycemic Agents/therapeutic use
  • Multicenter Studies as Topic
  • Observational Studies as Topic

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