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NCT07070882 | RECRUITING | Osteoarthritis, Knee

Oral Steroid Taper After Total Knee Arthroplasty
Sponsor:

Columbia University

Information provided by (Responsible Party):

Herbert John Cooper, MD

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).

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

Methylprednisolone

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : SINGLE
Primary Purpose : PREVENTION
Official Title : Effectiveness of an Oral Methylprednisolone Taper Following Primary Total Knee Arthroplasty
Actual Study Start Date : 2025-06-20
Estimated Primary Completion Date : 2026-06-20
Estimated Study Completion Date : 2027-06-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Oral Steroid Taper After Total Knee Arthroplasty

Location Details

NCT07070882

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Locations

RECRUITING

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032