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New treatment option for Total Knee Arthroplasty
Official title Medrol Dosepak for Outpatient Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT05097976
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for total knee arthroplasty.
Also referred to as medrol dosepak.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Any patient undergoing primary TKA with a diagnosis of osteoarthritis ≥ 18 years old
- Willingness to undergo randomization
You likely can't join if
- Reported chronic corticosteroid or opiate use
- Suspected or confirmed periprosthetic joint infection
- Revision TKA
- Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
- American Society of Anesthesiologists (ASA) score ≥ 4
- Reported history of liver disease, renal disease, or diabetes mellitus
See the full eligibility criteria
- Any patient undergoing primary TKA with a diagnosis of osteoarthritis ≥ 18 years old
- Willingness to undergo randomization
- Reported chronic corticosteroid or opiate use
- Suspected or confirmed periprosthetic joint infection
- Revision TKA
- Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
- American Society of Anesthesiologists (ASA) score ≥ 4
- Reported history of liver disease, renal disease, or diabetes mellitus
- Current systemic fungal infection or other local infection
- Immunocompromised or immunosuppressed
- Current peptic ulcer disease
- History of hypothyroidism, psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis
- Women with reported current pregnancy
- Known hypersensitivity to methylprednisolone ≤ 18 years old
- Inability to take oral medications
- Unable to provide consent
The study team makes the final eligibility decision.
Where it's taking place
- Oak Brook, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oak Brook, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.