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临床试验/NCT04873544
NCT04873544已完成不适用

Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2018年10月1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
69
试验地点
1
主要终点
the postoperative hospitalization time

研究概览

简要总结

The study aimed to investigate the impact of enhanced recovery after surgery (ERAS) protocols on the clinical effect of total knee arthroplasty (TKA) via the midvastus approach

详细描述

In this study, a randomized controlled study was conducted to further investigate the impact of ERAS protocols in the clinical efficacy of TKA with the midvastus approach. The ERAS protocols were adopted for the ERAS group and consisted of pure juice drinking 2 hours before the surgery, optimization of the preoperative anesthesia plan, phased use of tourniquets, and the use of tranexamic acid as well as a drug cocktail. The operative time, first postoperative walking time, first straight leg elevation time, postoperative hospitalization time, visual analogue scale score (VAS score), New York Hospital of Special Surgery knee score (HSS score), Knee Society Score (KSS score), and knee range of motion were used to assess the clinical effects in the two groups. All the included patients were followed up for 12 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
56 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral primary knee osteoarthritis
  • Varus, valgus, and flexion contracture deformity of the knee joint < 10°
  • The range of motion of the knee joint was > 80°
  • Body mass index (BMI) < 30
  • No previous history of knee surgery on the affected side .Agreed to participate in the trial.

排除标准

  • Rheumatoid arthritis
  • Extra-knee deformity
  • Simultaneous bilateral knee arthroplasty
  • Severe dysfunction of the liver, kidney, and blood system
  • Severe cardiovascular diseases
  • Gastrointestinal ulcer .Other medical conditions like nausea, vomiting, snoring, and allergy to related analgesic drugs.

结局指标

主要结局

the postoperative hospitalization time

时间窗: 12 months

the postoperative hospitalization time

次要结局

  • visual analogue scale score (VAS score)(12 months)
  • New York Hospital of Special Surgery knee score (HSS score)(12 months)
  • the operative time(2 hours)
  • first straight leg elevation time(1 day)
  • knee range of motion(12 months)
  • first postoperative walking time(1 day)
  • Knee Society Score (KSS score)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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