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

BACKGROUND: Diabetes mellitus is a surgical risk factor, yet perioperative diabetes management remains debated, with inconsistent guidelines and limited consideration on the implementation of "enhanced recovery after surgery" (ERAS) programs. A detailed prospective observational multicenter study was launched to investigate perioperative risk factors and outcomes in diabetic patients undergoing modern optimized hip and knee arthroplasty within an established ERAS program. METHODS: This study reports on the feasibility of launching prospective detailed observational studies as part of daily clinical practice within a multicenter collaboration, focusing on data completeness and successful recruitment.The feasibility analysis was conducted from October 1, 2022, to January 31, 2024, across eight public arthroplasty centers in Denmark, in diabetic patients undergoing elective primary total hip (THA), total knee (TKA), or unicompartmental knee (UKA) arthroplasty. Prospective data collection included antihyperglycemic medication, preoperative HbA1c, data on perioperative diabetes management, length of stay (LOS), and readmission after surgery. RESULTS: The cohort comprised 1007 DM patients (37.6% (n = 379) THA, 44.5% (n = 448) TKA, 17.9% (n = 180) UKA) with a mean age of 70.7 years (SD 8.8), and the median age was 71 (IQR 65-77); 48% were female and 19% were insulin-treated. Data on the type of preoperative antihyperglycemic medications was available in 100% of patients. LOS was registered in 100% of patients, and 90-day follow-up was completed in 99% of patients. Preoperative HbA1c assessment increased from 68% in February 2023 to 96% in January 2024. From March 1st, 2023, data on perioperative diabetes management was available for 98% of all patients, with a total completion variation between 94 and 96% across the included parameters. CONCLUSION: The study demonstrates the feasibility of a prospective multicenter setup for detailed data collection on diabetic patients undergoing ERAS hip or knee arthroplasty. The high compliance rates of key metrics (≥ 94%) support that data completeness and quality are sufficient to proceed with the main study to assess the impact of diabetes and its management on outcomes within an ERAS program in 2000 patients, since enrollment exceeded expectations. TRIAL REGISTRATION: ClinicalTrials.gov. NCT05613439. Registered on 9 January 2022, https://clinicaltrials.gov/study/NCT05613439?id=NCT05613439&rank=1.