Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty
Completed
Hospital for Special Surgery, New York
Phase 4
2011-02-01
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.
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