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临床试验/NCT07630337
NCT07630337招募中不适用

Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1

研究概览

简要总结

The goal of this clinical trial is to learn if compressive cryotherapy can reduce postoperative opioid consumption in patients undergoing primary total knee arthroplasty. It will also evaluate whether compressive cryotherapy improves postoperative recovery compared with standard care using conventional ice application. The main questions it aims to answer are:

Does compressive cryotherapy reduce the total consumption of opioids during the first 7 days after total knee arthroplasty?

Does compressive cryotherapy reduce postoperative pain and improve early recovery compared with standard cryotherapy?

Researchers will compare compressive cryotherapy using the Game Ready® device with standard care using traditional ice packs to determine whether the intervention reduces opioid consumption and improves postoperative outcomes.

Participants will:

Be randomly assigned to receive compressive cryotherapy or standard cryotherapy with ice packs after surgery.

Apply the assigned treatment four times per day during the first 7 postoperative days.

Record daily pain levels using a visual analog scale (VAS) and document opioid consumption in a pain diary.

Attend a follow-up visit on postoperative day 7 for evaluation of knee swelling, hematoma size, and recovery using the QoR-15 questionnaire.

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

盲法说明

This is an open-label trial. Due to the nature of the intervention (compressive cryotherapy device versus conventional ice application), masking of participants and care providers is not feasible.

入排标准

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

入选标准

  • Age between 60 and 80 years
  • Scheduled to undergo primary total knee arthroplasty for knee osteoarthritis
  • Ability to understand the study procedures and provide written informed consent

排除标准

  • Revision total knee arthroplasty
  • Vascular disorders affecting the lower limbs
  • Body mass index (BMI) greater than 35 kg/m²
  • Active knee infection
  • Severe preoperative limitations in knee mobility

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignacio Garcia Mansilla

Knee Orthopedic Surgeon

Hospital Italiano de Buenos Aires

研究点 (1)

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