Oral Steroid Taper After Total Knee Arthroplasty

NCT ID: NCT07070882

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2027-06-20

Brief Summary

This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA).

Detailed Description

This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA). While intravenous (IV) corticosteroids have been shown to provide short-term pain relief in the immediate postoperative period, their effects are limited to the first 24 hours. Given the inflammatory nature of TKA recovery, extending steroid administration through an oral taper may provide additional benefits in pain control, opioid reduction, and functional recovery. This study will assess whether adding an oral steroid taper to standard multimodal pain management improves clinical outcomes in TKA patients.This prospective, single-blinded, randomized controlled trial will enroll adults aged 18 and older undergoing primary TKA for osteoarthritis at Columbia University Medical Center.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients receiving oral methylprednisolone

Patients receiving a six-day oral methylprednisolone taper (21 tablets, 4 mg each) in addition to standard multimodal pain management

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

Patients will receive a tapered dose of methylprednisolone with the standard of care pain management

Patients receiving standard pain management without the taper

Patients receiving standard pain management without the taper

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Methylprednisolone

Patients will receive a tapered dose of methylprednisolone with the standard of care pain management

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Any patient undergoing primary TKA with a diagnosis of osteoarthritis
• > 18 years old
• Willingness to undergo randomization
• Patients who will be home by postoperative day (POD) #1 to start the dosing schedule that day (includes both ambulatory and POD #1 discharge patients)

Exclusion Criteria

• Reported chronic corticosteroid or opiate use prior to surgery
• Prior Open Surgery on the Ipsilateral Knee
• Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, septic arthritis, or postoperative 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Herbert John Cooper, MD

Associate Professor of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Columbia University Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacqueline Lenahan

Role: CONTACT

jl5092@cumc.columbia.edu

917-583-2885

Facility Contacts

Herbert John Cooper, MD

Role: primary

hjc2008@cumc.columbia.edu

212-305-6959

Other Identifiers

AAAV7426

Identifier Type: -

Identifier Source: org_study_id