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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative days 1 through 7 (week 1)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am having a knee replacement due to osteoarthritis.

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid consumption at one-week postoperative

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,081 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any vacancies for this experiment?

"Affirmative. Per the information found on clinicaltrials.gov, this medical trial is actively enrolling patients and was initially posted in March of 2022 with last edited date being November 15th of that same year. 420 participants are needed at one specific site for evaluation purposes."

Answered by AI

How many individuals are actively participating in this research?

"Affirmative. Clinicaltrials.gov records show that this medical research is currently recruiting; the trial was initiated on March 1st, 2022 and last modified November 15th of the same year. 420 individuals are required to be recruited from one location in order to complete the study."

Answered by AI

Has Methylprednisolone been employed in any other clinical research?

"Presently, there are 39 Phase 3 and 150 overall active clinical trials for Methylprednisolone. Houston, Texas is the epicentre of these experiments but they can also be found in 6845 other locations across the globe."

Answered by AI

In what instances is Methylprednisolone commonly prescribed?

"Methylprednisolone is a commonly prescribed medication for ophthalmia, sympathetic and other autoimmune disorders like lupus erythematosus, scalp structure and temporal arteritis."

Answered by AI

Has Methylprednisolone been granted regulatory authorization by the FDA?

"By evaluating the Phase 4 status of Methylprednisolone, our team assessed it to have a safety rating of 3. This level signifies that this medication has already been approved by regulatory bodies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Medrol Dosepak for Outpatient Total Knee Arthroplasty

Craig J Della Valle, MD 2022. "Medrol Dosepak for Outpatient Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05097976.

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