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Steroids in Total Knee Arthroplasty

Primary Purpose

Postoperative Pain, Inflammation, Osteoarthritis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone 10 mg
Dexamethasone 20 mg
Standard multimodal pain management regimen
Placebo
Sponsored by
Thomas L Bradbury
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Osteoarthritis, Postoperative pain, Total knee arthroplasty, Orthopaedics, Inflammation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Orthopedic and Spine Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Dexamethasone 10 mg

Dexamethasone 20 mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Antiemetic Dose Administered
Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.
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).
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.
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.
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.
Number of Participants Readmitted to the Hospital
The number of participants with hospital readmissions after being discharged were recorded.
Number of Participants With Wound Infections
The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.

Full Information

First Posted
August 13, 2014
Last Updated
September 6, 2022
Sponsor
Thomas L Bradbury
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1. Study Identification

Unique Protocol Identification Number
NCT02219581
Brief Title
Steroids in Total Knee Arthroplasty
Official Title
Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated after considerable time in suspended state due to inadequate staffing, the COVID pandemic, and the Responsible Party leaving Emory in August 2022.
Study Start Date
October 16, 2014 (Actual)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas L Bradbury

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inflammation, Osteoarthritis
Keywords
Osteoarthritis, Postoperative pain, Total knee arthroplasty, Orthopaedics, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Dexamethasone 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Dexamethasone 20 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 10 mg
Other Intervention Name(s)
Decadron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 20 mg
Other Intervention Name(s)
Decadron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard multimodal pain management regimen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Score
Description
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.
Time Frame
Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
Title
Opioid Analgesic Usage
Description
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.
Time Frame
1 day post-operatively
Secondary Outcome Measure Information:
Title
Soft Tissue Swelling
Description
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.
Time Frame
1 day post-operatively
Title
Range of Motion (ROM)
Description
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.
Time Frame
Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
Title
Post-operative Day of Physical Therapy Clearance
Description
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.
Time Frame
Up to 3 days post-operatively
Title
Antiemetic Dose Administered
Description
Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.
Time Frame
Post-operative Days 1 and 2
Title
Blood Glucose
Description
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).
Time Frame
Baseline, Post-operative Day 1
Title
36-Item Short Form Health Survey (SF-36) Score
Description
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.
Time Frame
Baseline, 12 months post-operatively
Title
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
Description
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.
Time Frame
Baseline, 1, 4, and 12 months post-operatively
Title
Length of Hospital Stay
Description
The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.
Time Frame
Up to 3 days post-operatively
Title
Number of Participants Readmitted to the Hospital
Description
The number of participants with hospital readmissions after being discharged were recorded.
Time Frame
Up to 12 months post-operatively
Title
Number of Participants With Wound Infections
Description
The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.
Time Frame
Up to 12 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Bradbury, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Orthopedic and Spine Hospital
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Steroids in Total Knee Arthroplasty

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