RECRUITING
I'm interested ...!!
Medrol Dosepak for Outpatient Total Knee Arthroplasty
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.
Conditions:
🦠 Total Knee Arthroplasty
🗓️ Study Start (Actual) 1 March 2022
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 420
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Oak Brook, Illinois, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 October 2021
  • First Submitted that Met QC Criteria 18 October 2021
  • First Posted 28 October 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024
I'm interested ...!!