Osteoarthritis, Knee
Conditions
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.
Interventions
DRUGMethylprednisolone
Patients will receive a tapered dose of methylprednisolone with the standard of care pain management
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean postoperative pain over post-operative days 1-6 (POD1-6) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Patient will complete the KOOS Jr. The total score ranges from 0 indicating knee disability to 100 representing perfect knee health. |
| Postoperative nausea and vomiting (PONV) score | 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. |
| Daily opioid use | 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. |
| Ondansetron use | 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. |
| Knee Range of motion (ROM) | 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. |
Countries
United States
Outcome results
None listed