Steroids in Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT02219581 |
Recruitment Status :
Suspended
(Suspended pending acquisition of additional study staff.)
First Posted : August 19, 2014
Last Update Posted : November 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Postoperative Pain Inflammation Osteoarthritis | Drug: Dexamethasone 10 mg Drug: Dexamethasone 20 mg Drug: Standard multimodal pain management regimen Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | November 2021 |

Arm | Intervention/treatment |
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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.
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Drug: Standard multimodal pain management regimen
The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative:
Intraoperative:
Postoperative
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.
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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 Name: Decadron Drug: Standard multimodal pain management regimen The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative:
Intraoperative:
Postoperative
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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: 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 Name: Decadron Drug: Standard multimodal pain management regimen The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative:
Intraoperative:
Postoperative
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- Change in pain scores [ Time Frame: Baseline, 48 hours post-operatively (average length of inpatient stay) ]Postoperative pain will be 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 subject will be asked to choose the face that best describes their level of pain and their responses will be recorded. Higher scores indicate higher intensities of pain.
- Pain scores as recorded by the smart device app [ Time Frame: 7 days post-operatively ]Subjects will answer questions about their pain and record their responses using the app on their smart device.
- Change in pain scores [ Time Frame: 1 month post-operatively, 12 months post-operatively ]Postoperative pain will be 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 subject will be asked to choose the face that best describes their level of pain and their responses will be recorded. Higher scores indicate higher intensities of pain.
- Opioid analgesic usage [ Time Frame: Baseline, 2 weeks post-operatively ]The amount of each subject's postoperative opioid analgesic usage (converted into milligrams of morphine equivalents per day) will be recorded. The subjects will be asked to use a pain medication usage log to track the use of both prescribed narcotic medications and over the counter non-steroidal anti-inflammatory medications for knee pain.
- Soft tissue swelling [ Time Frame: Baseline, 1 day post-operatively ]Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be used as the value for that day.
- Soft tissue swelling [ Time Frame: 1 month post-operatively, 12 months post-operatively ]Soft tissue swelling will be evaluated using a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient. This measurement will be completed twice, and the average of the two measurements will be the value for that day.
- Change in range of motion (ROM) [ Time Frame: Baseline, 1 day 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.
- Change in range of motion (ROM) [ Time Frame: 1 month post-operaively, 12 months post-opreatively ]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 to clearance from physical therapy [ Time Frame: 2 days post-operatively ]The post-operative day when the subject is cleared by the physical therapy staff to go home will be recorded. A shorter clearance time is indicative of better joint function.
- Post-operative nausea [ Time Frame: Up to 1 month post-operatively ]The use of as-needed antiemetics will be recorded for each subject. Subjects will also be specifically asked about episodes of emesis using the BARF scale where each item is scored from 0= no nausea to 10= emesis.
- Post-operative vomiting [ Time Frame: Up to 1 month post-operatively ]The use of as-needed antiemetics will be recorded for each subject. Subjects will also be specifically asked about episodes of emesis using the BARF scale where each item is scored from 0= no nausea to 10= emesis.
- Levels of blood glucose [ Time Frame: Baseline, 48 hours post-operatively ]The subject's blood glucose level will be analyzed using a Hemocue analyzer.
- Functionality scores using Short Form using (SF)-36 [ Time Frame: Baseline, 12 months post-operatively ]The subjects' functional ability will be assessed using the Short Form (SF)-36 questionnaire. The Short Form-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.
- Functionality scores using (WOMAC) [ Time Frame: Baseline, 12 months post-operatively ]The and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire will be used to assess joint function. administered to patients at the baseline visit and at each follow up clinic visit. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
- Length of hospital stay [ Time Frame: 12 months post-operatively ]The length of each subject's hospital stay in days will be recorded. Higher number of days in the hospital indicate slower recovery.
- Number of hospital readmissions [ Time Frame: 12 months post-operatively ]The number of subjects who need readmission to the hospital will be recorded.
- Number of subjects with wound infections [ Time Frame: 1 month post-operatively, 12 months post-operatively ]The number of subjects with the clinical presence of wound drainage and periprosthetic infection will be recorded.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219581
United States, Georgia | |
Emory Orthopedic and Spine Hospital | |
Tucker, Georgia, United States, 30084 |
Principal Investigator: | Thomas L Bradbury, MD | Emory University |
Responsible Party: | Thomas L Bradbury, MD, Thomas L Bradbury MD, Emory University |
ClinicalTrials.gov Identifier: | NCT02219581 |
Other Study ID Numbers: |
IRB00066081 |
First Posted: | August 19, 2014 Key Record Dates |
Last Update Posted: | November 19, 2019 |
Last Verified: | November 2019 |
Osteoarthritis Postoperative pain Total knee arthroplasty Orthopaedics Inflammation |
Osteoarthritis Inflammation Pain, Postoperative Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pathologic Processes Postoperative Complications Pain Neurologic Manifestations Dexamethasone Dexamethasone acetate BB 1101 |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |