Clinical trial NCT02219581: Steroids in Total Knee Arthroplasty
Official title: Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Pain
Inflammation
Osteoarthritis
Keywords: Osteoarthritis
Postoperative pain
Total knee arthroplasty
Orthopaedics
Inflammation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Score
timeFrame: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
measure: Opioid Analgesic Usage
timeFrame: 1 day post-operatively
Secondary outcomes:
measure: Soft Tissue Swelling
timeFrame: 1 day post-operatively
measure: Range of Motion (ROM)
timeFrame: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
measure: Post-operative Day of Physical Therapy Clearance
timeFrame: Up to 3 days post-operatively
measure: Antiemetic Dose Administered
timeFrame: Post-operative Days 1 and 2
measure: Blood Glucose
timeFrame: Baseline, Post-operative Day 1
measure: 36-Item Short Form Health Survey (SF-36) Score
timeFrame: Baseline, 12 months post-operatively
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
timeFrame: Baseline, 1, 4, and 12 months post-operatively
measure: Length of Hospital Stay
timeFrame: Up to 3 days post-operatively
measure: Number of Participants Readmitted to the Hospital
timeFrame: Up to 12 months post-operatively
measure: Number of Participants With Wound Infections
timeFrame: Up to 12 months post-operatively
Other outcomes:
Locations:
city: Tucker
country: United States
facility: Emory Orthopedic and Spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Thomas L Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References: