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Recruiting
NCT05097976
Medrol Dosepak for Outpatient Total Knee Arthroplasty
Conditions: Total Knee Arthroplasty
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 420
Sponsor: Rush University Medical Center
Location: Rush Oak Brook Outpatient Center Oak Brook Illinois
Summary
The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.
Eligibility Criteria
Inclusion Criteria:
* Any patient undergoing primary TKA with a diagnosis of osteoarthritis
•≥ 18 years old
* Willingness to undergo randomization
Exclusion Criteria:
* Reported chronic corticosteroid or opiate use
* Suspected or confirmed periprosthetic joint infection
* Revision TKA
* Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
* American Society of Anesthesiologists (ASA) score ≥ 4
* Reported history of liver disease, renal disease, or diabetes mellitus
* Current systemic fungal infection or other local infection
* Immunocompromised or immunosuppressed
* Current peptic ulcer disease
* History of hypothyroidism, psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis
* Women with reported current pregnancy
* Known hypersensitivity to methylprednisolone
•≤ 18 years old
* Inability to take oral medications
* Unable to provide consent
Source: ClinicalTrials.gov (NCT05097976). StuddyBuddy aggregates publicly available trial information.