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Corticosteroid

Methylprednisolone for Knee Arthritis

Phase 4
Waitlist Available
Led By Johannes F Plate
Research Sponsored by F. Johannes Plate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients indicated for primary total knee arthroplasty
Be older than 18 years old
Must not have
Patients with a history of peptic ulcer disease
Patients less than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-week, 6-week and 3-month postoperative visits
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

"This trial is testing if a specific steroid medication, methylprednisolone, can improve patient outcomes after knee replacement surgery. The steroid will be given in decreasing doses over time to see if it helps

Who is the study for?
This trial is for individuals with knee arthritis who have undergone total knee arthroplasty. Participants should be interested in improving postoperative pain and range of motion. Specific inclusion and exclusion criteria are not provided, but typically would involve age, overall health status, and absence of conditions that could interfere with the study.
What is being tested?
The study tests if a tapering dose of methylprednisolone after surgery can improve functional outcomes compared to just using dexamethasone during surgery. A taper involves starting with a high dose then gradually reducing it over several days.
What are the potential side effects?
Possible side effects may include increased blood sugar levels, mood swings, increased appetite, trouble sleeping, indigestion or heartburn from methylprednisolone; dexamethasone might cause similar effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am recommended to have a total knee replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had peptic ulcers in the past.
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I am under 18 years old.
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I am unable to give consent by myself.
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I have a history of heart failure.
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I have a history of kidney or liver failure.
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I am on long-term steroid medication.
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I manage my chronic pain with opioids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-week, 6-week and 3-month postoperative visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-week, 6-week and 3-month postoperative visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Daily Pain at rest and with movement
Knee Range of motion
Prescription narcotic usage
+1 more
Secondary study objectives
Knee Injury and Osteoarthritis Outcome Scores
Wound healing
Other study objectives
Postoperative complications

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intraoperative and Post-operative steroidExperimental Treatment2 Interventions
Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper
Group II: Intraoperative SteroidActive Control1 Intervention
Patients randomized to this group will only receive intraoperative intravenous dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone injection
2019
Completed Phase 4
~390

Find a Location

Who is running the clinical trial?

F. Johannes PlateLead Sponsor
Johannes F PlatePrincipal InvestigatorUniversity of Pittsburgh
~67 spots leftby Oct 2025
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