Steroids in Total Knee Arthroplasty

Phase 4

Terminated

Conditions: Postoperative Pain
Osteoarthritis
Inflammation

Interventions: Drug: Standard multimodal pain management regimen
Drug: Dexamethasone 10 mg
Drug: Dexamethasone 20 mg
Drug: Placebo

Registration Number: NCT02219581

Lead Sponsor: Thomas L Bradbury

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Standard multimodal pain management regimen	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.
Placebo	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.
Dexamethasone 10 mg	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.
Dexamethasone 10 mg	Standard multimodal pain management regimen	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.
Dexamethasone 20 mg	Standard multimodal pain management regimen	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.
Dexamethasone 20 mg	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.

Primary Outcome Measures

Name	Time	Method
Pain Score	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	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 Outcome Measures

Name	Time	Method
Soft Tissue Swelling	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)	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	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.
Blood Glucose	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	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	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.
Number of Participants Readmitted to the Hospital	Up to 12 months post-operatively	The number of participants with hospital readmissions after being discharged were recorded.
Number of Participants With Wound Infections	Up to 12 months post-operatively	The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.
Antiemetic Dose Administered	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.
Length of Hospital Stay	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.

Trial Locations

Locations (1): Emory Orthopedic and Spine Hospital
🇺🇸
Tucker, Georgia, United States
Emory Orthopedic and Spine Hospital
🇺🇸Tucker, Georgia, United States