The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Prescription narcotic usage
研究概览
简要总结
Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients indicated for primary total knee arthroplasty.
- •Access to computer or smartphone for completion of REDCap surveys
排除标准
- •Patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an HgbA1c >6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. Those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.
研究组 & 干预措施
Intraoperative and Post-operative steroid
Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper
干预措施: Methylprednisolone 4 milligram Tab (Drug)
Intraoperative and Post-operative steroid
Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper
干预措施: Dexamethasone injection (Drug)
Intraoperative Steroid
Patients randomized to this group will only receive intraoperative intravenous dexamethasone
干预措施: Dexamethasone injection (Drug)
结局指标
主要结局
Prescription narcotic usage
时间窗: daily for two weeks
Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication
Daily Pain at rest and with movement
时间窗: daily for two weeks
numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain
Sleep disturbance
时间窗: daily for two weeks
Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time
Knee Range of motion
时间窗: 2-week, 6-week and 3-month postoperative visits
goniometric measurement of knee extension and flexion
次要结局
- Wound healing(2-week, 6-week and 3-month postoperative visits)
- Knee Injury and Osteoarthritis Outcome Scores(2-week, 6-week and 3-month postoperative visits)
研究者
F. Johannes Plate
Director of Research Division of Adult Reconstruction
University of Pittsburgh