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临床试验/NCT03790306
NCT03790306已完成不适用

Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty

St. Elizabeth Medical Center, Utica, NY1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
1
主要终点
Short Physical Performance Battery

研究概览

简要总结

To prove that anterior approach total hip arthroplasty using the HANA table can be performed with little, if any, need for opioids using a combination of education, optimized pre op and post op pain protocols and optimized recovery tools.

详细描述

Methods:

Data Collection:

  • pre-op assessment/physical therapy evaluation
  • post op assessment - PACU, phase II (Prior to discharge)
  • phone calls after discharge (post op day 1, 2, 3)
  • follow up assessment in surgeon's office (3 and 6 weeks post op)
  • Ortech
  • Swiftpath
  • HOOS jr

Pre-optimization:

  • All patients enroll in SwiftPath education program
  • Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective total hip arthroplasty
  • unilateral
  • patient surgeries scheduled to be performed at the hospital and surgery center
  • patients must enroll in SwiftPath
  • Ability to read and understand English

排除标准

  • Patient diagnosis of schizophrenia, bipolar disease, dementia
  • previous burn to affected extremity
  • BMI > 40
  • Hemoglobin <12 female, <13 male
  • Albumin less than 3.5
  • A1C >8.0

结局指标

主要结局

Short Physical Performance Battery

时间窗: 6 Weeks

Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.

Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period

时间窗: 6 weeks

Number of patients that took any opioids throughout 6-week follow-up period

Pre-operative Narcotic Use

时间窗: Pre-operatively

Percentage of patients that used used opioids pre-operatively

次要结局

  • Sleep Quality(6 Weeks)
  • Number of Patients That Return to Work 6 Weeks After Surgery(6 weeks)
  • Number of Patients Who Return to Driving 6 Weeks After Surgery(6 Weeks)
  • Length of Stay in Hospital(1 week)
  • Numeric Pain Scores(6 Weeks)
  • Number of Participants Who Adhere to Prescribed Post op Recovery Protocol(2 weeks)

研究者

发起方
St. Elizabeth Medical Center, Utica, NY
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Andrew B. Wickline

Orthopedic Surgeon

St. Elizabeth Medical Center, Utica, NY

研究点 (1)

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