Osteoarthritis | Risk Factor Control Before Orthopedic Surgery
Osteoarthritis research study
What is the primary objective of this study?
This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.
Who is eligible to participate?
Inclusion Criteria: - • ≥ 21 years of age - Subjects undergoing open orthopedic surgery of the hip, knee or spine - Surgery is scheduled at least 3 days after PAT visit and no more than 14 days. - High risk subject cohort - Coronary artery disease, or - Cerebrovascular disease (prior stroke, TIA or carotid artery disease (>70% stenosis), or - Peripheral artery disease, or - Prior Venous thromboembolism or arterial thromboembolism, or - Age ≥ 60 years and 2 of the following - Renal insufficiency (creatinine clearance < 60ml/min) - Diabetes - COPD - Hypertension - Active smoker or stopped less than 30 days prior to consent - Cancer (excluding BCC) - Heart Failure Exclusion Criteria: - • Known intolerance to statins - Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily) - Bilateral renal artery stenosis - End stage renal disease (receiving dialysis or CrCl <30ml/min) - Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia) - Known allergy or intolerance to beta blockers - Known sick sinus syndrome not treated with permanent pacemaker - Known greater than first degree AV block not treated with a pacemaker - Excessive alcohol intake - Acute Coronary Syndrome requiring hospitalization within 1 month - Stroke within 1 month - Known pregnancy - Severe co-morbid condition with life expectancy < 6 months - Inability to give informed consent or adhere to follow-up as per protocol - Current participation in another investigational drug or device trial
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Metoprolol25mg PO BID if the HR is elevated at preadmission testing
Drug:Lisinopril2.5mg PO QD if the HR is elevated at preadmission testing
Drug:Atorvastatin80mg PO QD at preadmission testing
Behavioral:Lifestyle counselingDiet, exercise, medication adherance and smoking counseling
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TreatmentLifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated
ControlStandard of care
Start Date: February 2014
Completed Date: December 2018
Phase: Phase 4
Primary Outcome: Composite of cardiovascular events
Secondary Outcome: Modified composite of cardiovascular events
Study sponsors, principal investigator, and references
Principal Investigator: Jeffrey Berger, MD
Lead Sponsor: New York University School of Medicine