Medrol Dosepak for Outpatient Total Knee Arthroplasty

Part of paid clinical trials in Oak Brook, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT05097976
Phase
PHASE4
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Methylprednisolone — DRUG
    21 x 4mg tablets beginning on POD 1
  • Placebo — DRUG
    21 sugar tablets beginning on POD 1 with standard management

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Apr 2026
Primary completion
May 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Methylprednisolone taper
    Methylprednisolone taper - 21 x 4mg tablets beginning on POD 1
  • Placebo Comparator: Placebo taper
    2.Placebo taper - 21 sugar tablets beginning on POD 1 with standard management

Primary Outcome Measure

Opioid consumption at one-week postoperative [ Time Frame: one week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush Oak Brook Outpatient CenterOak BrookIllinois60523
Anne DeBenedetti, BA
[email protected]
312-432-2468
craig Della Valle, MD (PRINCIPAL_INVESTIGATOR)
scott sporer, md (SUB_INVESTIGATOR)
tad gerlinger, md (SUB_INVESTIGATOR)

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By research site
Rush Oak Brook Outpatient Center· Oak Brook, IL

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