Oral Steroid Taper After Total Knee Arthroplasty

NCT07070882 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: AAAV7426
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Mean postoperative pain over post-operative days 1-6 (POD1-6)

  Pain will be assessed using a 0-100 visual analog scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Pain will be assessed during knee flexion to 90 degrees and with ambulation, and daily scores will be averaged across post-operative days 1-6 (POD1-6) for each patient to derive the primary outcome.

  Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

Secondary Outcomes (5)

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)

  Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6; first postoperative clinic visit (approximately 2 weeks); second postoperative visit (approximately 8 weeks)

• Postoperative nausea and vomiting (PONV) score

  Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

• Daily opioid use

  Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

• Ondansetron use

  Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

• Knee Range of motion (ROM)

  first postoperative visit (approximately 2 weeks); second postoperative visits (approximately 8 weeks)

Study Arms (2)

Patients receiving oral methylprednisolone

EXPERIMENTAL

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

Drug: Methylprednisolone

Patients receiving standard pain management without the taper

NO INTERVENTION

Patients receiving standard pain management without the taper

Interventions

Methylprednisolone DRUG

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

Patients receiving oral methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 17, 2025
• Study Start: June 20, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 20, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)