Effectiveness of an Oral Methylprednisolone Taper Following Primary Total Knee Arthroplasty
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Mean postoperative pain over post-operative days 1-6 (POD1-6)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Patients receiving standard pain management without the taper
Patients receiving standard pain management without the taper
Patients receiving oral methylprednisolone
Patients receiving a six-day oral methylprednisolone taper (21 tablets, 4 mg each) in addition to standard multimodal pain management
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Mean postoperative pain over post-operative days 1-6 (POD1-6)
时间窗: 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.
次要结局
- 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))
研究者
Herbert John Cooper, MD
Associate Professor of Orthopedic Surgery
Columbia University