Overview
Medrol Dosepak for Outpatient Total Knee Arthroplasty
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-11-01
2024-11-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Rush University Medical CenterTreatments:
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