Steroids in Total Knee Arthroplasty

Overview

The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.

Full Title of Study: “Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 1, 2015

Detailed Description

Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.

Interventions

• Drug: Dexamethasone 10 mg
  • Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
• Drug: Dexamethasone 20 mg
  • Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
• Drug: Standard multimodal pain management regimen
  • The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative: Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group) Intraoperative: Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg) Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low. Postoperative Tylenol: 1000mg po q 8hr (scheduled) Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain Morphine patient-controlled analgesia (PCA): only for failure of the above Morphine Sulfate (MS) Contin: Use as backup prn pain
• Drug: Placebo
  • Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.

Arms, Groups and Cohorts

• Placebo Comparator: Placebo
  • Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
• Experimental: Dexamethasone 10 mg
  • Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
• Experimental: Dexamethasone 20 mg
  • Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.

Clinical Trial Outcome Measures

Primary Measures

• Pain Score
  • Time Frame: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
  • Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= “No hurt”, to a crying face at 10= “Hurts worst”. The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.
• Opioid Analgesic Usage
  • Time Frame: 1 day post-operatively
  • The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.

Secondary Measures

• Soft Tissue Swelling
  • Time Frame: 1 day post-operatively
  • Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.
• Range of Motion (ROM)
  • Time Frame: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
  • Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.
• Post-operative Day of Physical Therapy Clearance
  • Time Frame: Up to 3 days post-operatively
  • The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.
• Antiemetic Dose Administered
  • Time Frame: Post-operative Days 1 and 2
  • Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.
• Blood Glucose
  • Time Frame: Baseline, Post-operative Day 1
  • To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).
• 36-Item Short Form Health Survey (SF-36) Score
  • Time Frame: Baseline, 12 months post-operatively
  • The subjects’ functional ability will be assessed using the SF-36 questionnaire. The SF-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
  • Time Frame: Baseline, 1, 4, and 12 months post-operatively
  • The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.
• Length of Hospital Stay
  • Time Frame: Up to 3 days post-operatively
  • The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.
• Number of Participants Readmitted to the Hospital
  • Time Frame: Up to 12 months post-operatively
  • The number of participants with hospital readmissions after being discharged were recorded.
• Number of Participants With Wound Infections
  • Time Frame: Up to 12 months post-operatively
  • The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.

Participating in This Clinical Trial

Inclusion Criteria

• Patients undergoing primary total joint arthroplasty of the knee – Adult patients ages 18-100 years – Patients must have smart phone and/or device for app usage Exclusion Criteria:

• Current chronic steroid use – Patients undergoing revision knee surgery – Patients ambulating preoperatively with assistive devices – Patients with avascular necrosis of the operative knee – Patients with a history of an adverse reaction to glucocorticoid steroids – Patients unable to provide informed consent – Patients with inflammatory arthritis – Prisoners – Current smokers – Patients <18 years of age – Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study. – Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee. – Patients with diabetes. – Patients that have an intolerance to Toradol. – Patients that do not have smart phone and/or device for app usage

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Thomas L Bradbury
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Thomas L Bradbury, Associate Professor – Emory University
• Overall Official(s)
  • Thomas L Bradbury, MD, Principal Investigator, Emory University