Medrol Dosepak for Outpatient Total Knee Arthroplasty

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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