A Phase 1 interventional study of Methylprednisolone in Osteoarthritis, Knee, sponsored by Columbia University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Columbia University · Phase 1, Interventional, and Prevention
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).
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 116 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients will receive a tapered dose of methylprednisolone with the standard of care pain management
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.
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
Patient will complete the KOOS Jr. The total score ranges from 0 indicating knee disability to 100 representing perfect knee health.
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)
Postoperative nausea and vomiting (PONV) score
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.
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Daily opioid use
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.
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Ondansetron use
Patients will report the number of rescue ondansetron tablets taken during each 24-hour period over POD 1-6.
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Knee Range of motion (ROM)
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.
Time frame: first postoperative visit (approximately 2 weeks); second postoperative visits (approximately 8 weeks)
Plan to share: Undecided
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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