Steroids in Total Knee Arthroplasty

Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty

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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Osteoarthritis; Postoperative Pain
• Intervention / Treatment: Drug: Standard multimodal pain management regimen; Drug: Placebo; Drug: Dexamethasone 10 mg; Drug: Dexamethasone 20 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Tucker, Georgia, United States, 30084
      • Emory Orthopedic and Spine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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: 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.; Other Names: Decadron
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.	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: 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.; Other Names: Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	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.	Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
Opioid Analgesic Usage	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.	1 day post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft Tissue Swelling	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.	1 day post-operatively
Range of Motion (ROM)	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.	Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
Post-operative Day of Physical Therapy Clearance	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.	Up to 3 days post-operatively
Antiemetic Dose Administered	Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.	Post-operative Days 1 and 2
Blood Glucose	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).	Baseline, Post-operative Day 1
36-Item Short Form Health Survey (SF-36) Score	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.	Baseline, 12 months post-operatively
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score	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.	Baseline, 1, 4, and 12 months post-operatively
Length of Hospital Stay	The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.	Up to 3 days post-operatively
Number of Participants Readmitted to the Hospital	The number of participants with hospital readmissions after being discharged were recorded.	Up to 12 months post-operatively
Number of Participants With Wound Infections	The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.	Up to 12 months post-operatively

Collaborators and Investigators

• Sponsor: Thomas L Bradbury
• Investigators: Principal Investigator: Thomas L Bradbury, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 16, 2014
• First Posted (Estimate): August 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Osteoarthritis; Total knee arthroplasty; Postoperative pain; Orthopaedics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pain, Postoperative; Osteoarthritis; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: IRB00066081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No