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Medrol Dosepak for Outpatient Total Knee Arthroplasty

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion pushed from May 30, 2026 to May 30, 2027
    • Study completion pushed from Dec 2026 to Dec 2027
    • Site contact updated
    v10
  2. Primary completion date: Mar 2026 to May 30, 2026v9
  3. Primary completion date: Dec 2025 to Mar 2026
    • Site contact updated
    v8
  4. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2026
    • Site contact updated
    v7
  5. Primary completion date: Nov 2024 to Dec 2024
    • Study completion date: Nov 2025 to Dec 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Nov 2023 to Nov 2024
    • Study completion date: Nov 2024 to Nov 2025
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2021 to Mar 1, 2022
    • Site details revised
    v3
  4. Secondary endpoints: 7 to 12v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05097976
Lead Sponsor Rush University Medical Center
Conditions
(from sponsor)		 Total Knee Arthroplasty
Related terms Postoperative Pain
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov