Postoperative Prednisone Regimen in TKA and Its Effect on Continuous Glucose Levels
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Pain at Rest
研究概览
简要总结
This study compares the efficacy of a 5-day post-operative oral prednisone regimen (40 mg daily) with the standard intraoperative steroid regimen, focusing on pain, swelling, range of motion, opioid use, and glucose levels monitored continuously.
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
- None
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
- •Undergoing Primary Unicompartmental Knee Arthroplasty or Total Hip Arthroplasty
- •Age 18 and above
排除标准
- •Steroid therapy
- •Narcotic use within past 3 months
- •History of corticosteroid intolerance
- •Pregnancy
- •Uncontrolled diabetes
- •Doesn't own smart phone
- •Drop Criteria:
- •- 2nd dose of IV dexamethasone
研究组 & 干预措施
Post-operative Steroids
Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively.
干预措施: Prednisone (Drug)
Post-operative Steroids
Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively.
干预措施: Continuous Glucose Monitor (Device)
Post-operative Steroids
Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively.
干预措施: InkWell Health Tattoos (Other)
Standard of care
Participants will receive standard of care treatment, consisting of the intravenous administration of dexamethasone and periarticular administration of steroids intraoperatively.
干预措施: Continuous Glucose Monitor (Device)
Standard of care
Participants will receive standard of care treatment, consisting of the intravenous administration of dexamethasone and periarticular administration of steroids intraoperatively.
干预措施: InkWell Health Tattoos (Other)
结局指标
主要结局
Pain at Rest
时间窗: 2 weeks
Pain intensity at rest will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain.
Pain with Ambulation
时间窗: 2 weeks
Pain intensity with ambulation will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain.
次要结局
- Continuous Glucose Levels(2 weeks)
- Adverse Outcomes(2 weeks)
- Swelling(2 weeks)
- Range of Motion(2 weeks)
- Opioid Consumption(2 weeks)
研究者
Roshan P. Shah
Russell A. Hibbs Associate Professor of Orthopedics in Orthopedic Surgery and in Surgery
Columbia University