Medrol Dosepak for Outpatient Total Knee Arthroplasty

NCT05097976 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 21090203
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Opioid consumption at one-week postoperative

  Relative difference in cumulative opioid consumption at Post-op day 7, measured in morphine equivalents.

  one week

Secondary Outcomes (12)

• Patient reported outcome measures: Daily Visual Analogue Scale for Pain

  Week 1

• Patient reported outcome measures : Daily Visual Analogue Scale for Pain

  3 weeks

• Patient reported outcome measures: Daily Visual Analogue Scale for Pain

  6 weeks

• Patient reported outcome measures: Daily Visual Analogue Scale of nausea

  Postoperative days 1 through 7 (week one)

• Patient reported outcome measures: vomiting episodes

  Postoperative days 1 through 7 (week 1)

Study Arms (2)

Methylprednisolone taper

EXPERIMENTAL

Methylprednisolone taper - 21 x 4mg tablets beginning on POD 1

Drug: Methylprednisolone

Placebo taper

PLACEBO COMPARATOR

2.Placebo taper - 21 sugar tablets beginning on POD 1 with standard management

Drug: Placebo

Interventions

Methylprednisolone DRUG

21 x 4mg tablets beginning on POD 1

Also known as: medrol dosepak

Methylprednisolone taper

Placebo DRUG

21 sugar tablets beginning on POD 1 with standard management

Placebo taper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing primary TKA with a diagnosis of osteoarthritis
• ≥ 18 years old
• Willingness to undergo randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush Oak Brook Outpatient Center

Oak Brook, Illinois, 60523, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Craig Della Valle, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne DeBenedetti

CONTACT

3124322468; anne.debenedetti@rushortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator (surgeon) and participant (patient) will be blinded to whether they are discharged with a placebo or treatment (oral corticosteroid).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)