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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Patients receiving standard pain management without the taper | No Intervention | Patients receiving standard pain management without the taper |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Patients will receive a tapered dose of methylprednisolone with the standard of care pain management |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| 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. | 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. | 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. | 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. | first postoperative visit (approximately 2 weeks); second postoperative visits (approximately 8 weeks) |
| D012216 |
| Rheumatic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |