Oral Steroid Taper After Total Knee Arthroplasty

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT07070882
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2025-06-20
• Study First Submitted: 2025-06-28
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-06-20
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Surveys	Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 Post-Operative 2-3 weeks, and Post-Operative 6-10 weeks	Patient will report daily pain levels and nausea using Visual Analog Scale. The visual analog scale is from 0-10 with increments of 2 with 0 being no nausea and 10 being the worst and vomiting. Pain will also be documented similarly with 0 being no pain and 10 being the worst pain ever.

Secondary Outcome Measures

Name	Time	Method
Surveys	Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 Post-Operative 2-3 weeks, and Post-Operative 6-10 weeks	Patient will complete the KOOS Jr. Its calculates score from the survey questions answered with a score of 0 indicating knee disability and 100 representing perfect knee health.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States