NCT05097976 Medrol Dosepak for Outpatient Total Knee Arthroplasty
| NCT ID | NCT05097976 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rush University Medical Center |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 420 participants in total. It began in 2022-03-01 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Any patient undergoing primary TKA with a diagnosis of osteoarthritis •≥ 18 years old * Willingness to undergo randomization Exclusion Criteria: * 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
Contact & Investigator
Craig Della Valle, MD
PRINCIPAL INVESTIGATOR
Rush University Medical Center
Frequently Asked Questions
Who can join the NCT05097976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05097976 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05097976 currently recruiting?
Yes, NCT05097976 is actively recruiting participants. Contact the research team at anne.debenedetti@rushortho.com for enrollment information.
Where is the NCT05097976 trial being conducted?
This trial is being conducted at Oak Brook, United States.
Who is sponsoring the NCT05097976 clinical trial?
NCT05097976 is sponsored by Rush University Medical Center. The principal investigator is Craig Della Valle, MD at Rush University Medical Center. The trial plans to enroll 420 participants.