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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Metformin 500mg oral once daily for 7 days, increased to 1000mg (500mg twice daily) for another 7 days, taken in morning and evening with meals, for a total of 14 days of treatment prior to surgery. Continue dose on day of surgery and up to post operative day 2, or until time of discharge, whichever happens first.
Placebo tablet
Oregon Health & Science University
Portland, Oregon, United States
Rate of participant enrollment
Feasibility defined by an average of four participants per month successfully enrolled and randomized.
Time frame: 3 months
Rate of appropriate study drug administration
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.
Time frame: 3 months
Rate of participant adherence to trial intervention per protocol
Feasibility defined by ≥90% participant adherence to trial intervention per protocol.
Time frame: 3 months
Rate of participant retention to 90-day follow up
Feasibility defined by ≥90% retention to follow up at 90 days.
Time frame: 3 months
Perioperative glycemic variability
Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels
Time frame: 3 months
Sliding scale insulin utilization
Measured by total number of units administered from time of surgery to discharge.
Time frame: 3 months
Hospital length of stay
Measured in days.
Time frame: 3 months
90-day Rate of surgical site infection
Defined by criteria published by Centers for Disease Control and Prevention.
Time frame: 3 months
90-day Rate of periprosthetic joint infection
Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS).
Time frame: 3 months
90-day Rate of mortality
Time frame: 3 months
90-day rate of readmission
Time frame: 3 months
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