Medrol Dosepak for Total Knee Replacement
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are using chronic corticosteroids or opiates, you cannot participate in the trial.
What data supports the effectiveness of the drug Medrol Dosepak for total knee replacement?
Is Medrol Dosepak (Methylprednisolone) generally safe for humans?
Methylprednisolone, used in various forms like Medrol Dosepak, has been associated with complications when accidentally injected into the eye, causing retinal damage. However, when used correctly, it is generally considered safe, as studies show it is rapidly cleared from the body and does not cause significant tissue changes in controlled settings.13456
How is the drug Medrol Dosepak unique for total knee replacement?
Research Team
Craig Della Valle, MD
Principal Investigator
Rush University Medical Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a methylprednisolone taper or placebo starting on postoperative day 1 following total knee arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 weeks postoperatively
Treatment Details
Interventions
- Methylprednisolone
- Placebo
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor