Metformin Use in Patients Undergoing Total Joint Replacement Surgery
- Registration Number
- NCT06280274
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.
The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.
Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Male or female, age 18-99 years
- Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
- Ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use.
Note: Patients with or without type 2 diabetes are considered eligible. (E.g.)
- Type 2 diabetic on metformin
- Type 2 diabetic on metformin and other medication, including insulin
- Type 2 diabetic on medication but not metformin
- Pre-diabetic
- Non-diabetic
- Advanced renal insufficiency (glomerular filtration rate (GFR) < 45, or chronic kidney disease (CKD) stage 3B or higher)
- Advanced liver cirrhosis or failure (Child-Pugh class B or C)
- Congestive heart failure (New York Heart Association (NYHA) class 3 or 4)
- Current alcohol abuse within 30 days of surgery (>4 standard servings daily for men, >3 standard servings daily for women)
- Type 1 diabetes
- Received contrast dye within 48 hours of surgery
- Vulnerable populations: Children, pregnant women, neonates, decisionally impaired adults, prisoners
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablet Treatment Metformin Oral metformin hydrochloride
- Primary Outcome Measures
Name Time Method Rate of participant enrollment 3 months Feasibility defined by an average of four participants per month successfully enrolled and randomized.
Rate of appropriate study drug administration 3 months Feasibility defined by ≥90% participants receiving 1000mg metformin or placebo daily by day of surgery, assessed via combination of self-report and counting of remaining tablets.
Rate of participant retention to 90-day follow up 3 months Feasibility defined by ≥90% retention to follow up at 90 days.
Rate of participant adherence to trial intervention per protocol 3 months Feasibility defined by ≥90% participant adherence to trial intervention per protocol.
- Secondary Outcome Measures
Name Time Method 90-day Rate of mortality 3 months Perioperative glycemic variability 3 months Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels
Sliding scale insulin utilization 3 months Measured by total number of units administered from time of surgery to discharge.
Hospital length of stay 3 months Measured in days.
90-day Rate of surgical site infection 3 months Defined by criteria published by Centers for Disease Control and Prevention.
90-day Rate of periprosthetic joint infection 3 months Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS).
90-day rate of readmission 3 months
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States