RecruitingPhase 4NCT05097976

Medrol Dosepak for Outpatient Total Knee Arthroplasty

An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial

Sponsor

Rush University Medical Center

Enrollment

420 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Total Knee Arthroplasty

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

Min Age: 18 Years

Inclusion Criteria3

Any patient undergoing primary TKA with a diagnosis of osteoarthritis
≥ 18 years old
Willingness to undergo randomization

Exclusion Criteria15

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