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Corticosteroid

Medrol Dosepak for Total Knee Replacement

Phase 4
Recruiting
Led By Craig Della Valle, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient undergoing primary TKA with a diagnosis of osteoarthritis
≥ 18 years old
Must not have
Immunocompromised or immunosuppressed
Unable to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative days 1 through 7 (week 1)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test whether an oral methylprednisolone taper can help improve pain and function following outpatient total knee arthroplasty, as well as decrease opioid use, nausea, and complications.

Who is the study for?
This trial is for adults over 18 undergoing their first total knee replacement due to osteoarthritis. Participants must be willing to be randomly assigned a treatment and able to take oral medication. It's not for those with certain chronic diseases, immune system issues, or infections; pregnant women; or anyone unable to consent.
What is being tested?
The study tests if an oral steroid called methylprednisolone can reduce pain, improve function, lessen opioid use and nausea after knee surgery compared to a placebo. The effects are measured from the day after surgery up to six weeks postoperatively.
What are the potential side effects?
Methylprednisolone may cause side effects like mood changes, weight gain, increased blood sugar levels, higher risk of infection, stomach ulcers, and trouble sleeping. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a knee replacement due to osteoarthritis.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My immune system is weak due to a condition or medication.
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I am unable to give my consent.
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I cannot take medications by mouth.
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I am having or have had a second knee replacement surgery.
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I am 18 years old or younger.
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I do not have a fungal or other infection right now.
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I have a history of conditions like hypothyroidism, heart failure, or myasthenia gravis.
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I regularly use corticosteroids or opiates.
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My primary diagnosis is not osteoarthritis but could be avascular necrosis, a fracture, or post-traumatic arthritis.
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I am currently pregnant.
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I might have an infection around my artificial joint.
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My health is severely limited by my illness.
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I have an active stomach or intestinal ulcer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative days 1 through 7 (week one)
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative days 1 through 7 (week one) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid consumption at one-week postoperative
Secondary study objectives
Clinical outcome: range of motion
Patient reported outcome measures : Daily Visual Analogue Scale for Pain
Patient reported outcome measures: Daily Visual Analogue Scale for Pain
+4 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Methylprednisolone taperExperimental Treatment1 Intervention
Methylprednisolone taper - 21 x 4mg tablets beginning on POD 1
Group II: Placebo taperPlacebo Group1 Intervention
2.Placebo taper - 21 sugar tablets beginning on POD 1 with standard management
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
248,944 Total Patients Enrolled
Craig Della Valle, MDPrincipal InvestigatorRush University Medical Center
9 Previous Clinical Trials
1,768 Total Patients Enrolled

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05097976 — Phase 4
Total Knee Replacement Research Study Groups: Methylprednisolone taper, Placebo taper
Total Knee Replacement Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT05097976 — Phase 4
Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05097976 — Phase 4
~0 spots leftby Dec 2024
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