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NCT Number: NCT07070882

Oral Steroid Taper After Total Knee Arthroplasty

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Primary outcomes

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

    Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 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.

Secondary outcomes

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

    Time frame: 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)

    Patient will complete the KOOS Jr. The total score ranges from 0 indicating knee disability to 100 representing perfect knee health.

  2. Postoperative nausea and vomiting (PONV) score

    Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

    Postoperative nausea and vomiting (PONV) will be assessed daily by telephone from post-operative days 1-6, where 0 indicates no nausea and 100 indicates the worst possible nausea or active vomiting.

  3. Daily opioid use

    Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

    Daily opioid use will be recorded for POD1-6, including inpatient opioid administration on POD1, with patients reporting narcotic use for the preceding day. All opioids were converted to morphine milligram equivalents (MME) using the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain. Conversion MMEs used were: 7.5 MME for oxycodone 5 mg, 10 MME for hydromorphone 2 mg, 10 MME for hydrocodone 10 mg, 10 MME for tramadol 50 mg.

  4. Ondansetron use

    Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

    Patients will report the number of rescue ondansetron tablets taken during each 24-hour period over POD 1-6.

  5. Knee Range of motion (ROM)

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

    Knee range of motion (ROM) will be measured by the attending surgeon using a goniometer at the first (approximately 2 weeks) and second postoperative visits (approximately 8 weeks). Changes in range of motion will be calculated relative to the preoperative baseline. For flexion, postoperative flexion minus preoperative flexion was used, with positive values indicating improved flexion. Extension was recorded as degrees of flexion contracture using positive values only; change in extension was calculated as preoperative minus postoperative extension, with positive values indicating improved extension.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effectiveness of an Oral Methylprednisolone Taper Following Primary Total Knee Arthroplasty

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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