Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
MeSH terms: Thrombosis
Intervention: Hydrocortisone; Placebo
Intervention description: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.; Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Intervention MeSH terms: Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Orthopedic Procedures; Prostheses and Implants; Joint Prosthesis; Knee Prosthesis; Arthroplasty, Knee; Thromboembolism; Inflammation; B-Cell Differentiation Factor-2; Differentiation Factor-2, B-Cell; B-Cell Stimulatory Factor-2; BSF-2; IFN-beta 2; MGI-2; Interleukin-6 (IL-6); Steroids; Pregnenediones; Hydrocortisone; Physiological Effects of Drugs; Therapeutic Uses

Summary:

      One postoperative complication following unilateral or bilateral total knee arthroplasty is
      thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled
      clinical trial, researchers are investigating the effect of steroids on biochemical markers
      of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have
      been linked to postoperative depression following total knee arthroplasty surgery. Hence the
      investigators are also checking if use of hydrocortisone, a steroid, may help reduce the
      incidence of postoperative depression.

      Other studies have shown that surgery causes some reaction in the body that is consistent
      with inflammation. When the inflammation is extensive, it may affect different parts of the
      body. It may also lead to clotting disorders and result in blood clots. In a previous study
      by this principal investigator (see reference 22, "Use of low-dose steroids in decreasing
      cytokine release during bilateral total knee arthroplasty"), hydrocortisone was administered
      over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty.
      The investigator found lower levels of cellular markers consistent with inflammation
      (specifically the protein, IL-6). Steroid use also showed additional benefits, such as
      decreased pain and better range of motion at the knee.

      In this study, investigators recruit patients undergoing total knee arthroplasty surgery.
      Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a
      saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect
      on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients'
      oral analgesic use. To assess patients' well-being, patients are contacted one month and 3
      months following their surgeries and administered the Patient Health Questionnaire (see
      reference 23, "The PHQ-9: validity of a brief depression severity measure.") arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing unilateral or bilateral total knee replacement

          -  Age 50-90

        Exclusion Criteria:

          -  All patients on steroid therapy regardless of dose or duration of treatment or those
             requiring stress-dose steroids preoperatively

          -  Patients who are smokers

          -  Patients under 50 years of age

          -  Patients over 90 years of age

          -  Patients with diabetes

          -  Patients with a prior history of corticosteroid intolerance

          -  Patients with previous complications of steroid use