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临床试验/NCT04211987
NCT04211987已完成不适用

Evaluation of Functional Rehabilitation Fast Track Total Hip Arthroplasty vs Standard Care: a Randomized Controlled Trial

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2018年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Early functional outcomes

研究概览

简要总结

Fast-track total hip arthroplasty (THA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

详细描述

The aim of this protocol is to compare standard care and fast track total hip arthroplasties. The fast track care consists of:

  • preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
  • antalgic protocol administered only orally
  • early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position. The standard care consists of usual antalgic and physiotherapy post-operative care:
  • Antalgic protocol consist in intravenous drugs
  • the first physiotherapy session is the day after surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
  • BMI < 32
  • American Society of Anesthesiologists physical status classification system (ASA) </= 2
  • preoperative hemoglobin (HB) >13 g/dl
  • patients eligible for spinal anesthesia
  • presence of a care-giver

排除标准

  • psychiatric diseases
  • preoperative use of crutches
  • preoperative HB < 13 g/dl

结局指标

主要结局

Early functional outcomes

时间窗: Third post operative day

Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day. This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results.

次要结局

  • hospital staying(Third post operative day)
  • Harris Hip Score (HHS)(12 months after surgery)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(12 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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