Clinical trial NCT01815918
Conditions: Total Knee Arthroplasty
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
Sponsor: Hospital for Special Surgery, New York
Start date: 2011-02-01; Completion date: 2012-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose. arm 2: Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Interventions: intervention 1: Hydrocortisone intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose.

Protocol documents: