Oral Steroid Taper After Total Knee Arthroplasty

Columbia University

Status and phase

Enrolling

Phase 1

Conditions

Osteoarthritis, Knee

Treatments

Drug: Methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT07070882

AAAV7426

Details and patient eligibility

About

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).

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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