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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative days 1 through 7 (week one)

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

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

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

431 Previous Clinical Trials

157,981 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

~25 spots leftby Dec 2024

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