Recruiting

Medrol Dosepak

Sponsor:

Rush University Medical Center

Code:

NCT05097976

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Methylprednisolone

Placebo

Study Details

Brief 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.

Conditions

Total Knee Arthroplasty

Study ID

NCT05097976

Start date

Mar 1, 2022

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Methylprednisolone

21 x 4mg tablets beginning on POD 1

Placebo

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 and Locations

Central contacts

Anne DeBenedetti

3124322468anne.debenedetti@rushortho.com

Locations

Rush Oak Brook Outpatient Center

Recruiting

Oak Brook, Illinois, United States, 60523

Contacts

Anne DeBenedetti, BA

3124322468anne.debenedetti@rushortho.com

Principal Investigator:

craig Della Valle, MD

More Information

Sponsor

Rush University Medical Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Methylprednisolone
  • acute postoperative pain
  • acute function
  • opioid consumption
  • complications following total knee arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-07-09.