跳至主要内容
临床试验/NCT03806114
NCT03806114Unknown不适用

Impact of Dislocation Precautions on Fear and Function in Patients Undergoing Hip Replacement

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2019年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
212
试验地点
1
主要终点
Change in Oxford Hip Score

研究概览

简要总结

This study is looking at the impact of giving patients precautions, or restrictions for movement, when undergoing a total hip replacement. Have of the participants will receive precautions, while the other half will not receive any precautions.

详细描述

Patients undergoing hip replacements are often told by health care providers to avoid specific positions and activities to decrease the risk of their hip dislocating following their surgery. This, however, results in patients becoming more fearful of moving and leads to limitations in their function and decreased quality of life. Previous research has shown that hip dislocations following surgery are most commonly attributed to poor implant position rather than the actions of the patients. Teaching precautions takes up healthcare resources and may use finances that are not necessarily required. This study aims to compare groups with half receiving precautions and half not receiving precautions, to assess the impact of precautions on the patients' quality of life.

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
Single (Outcomes Assessor)

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

  • •Receiving a primary total hip arthroplasty (THA) due to osteoarthritis or osteonecrosis
  • •Willing and able to sign consent

排除标准

  • •Receiving a lateral approach hip arthroplasty
  • •Cannot make follow up visits

研究组 & 干预措施

Anterior Approach Precautions

Other

This group receives precautions and have a total hip arthroplasty with a posterior approach.

干预措施: Anterior Approach Precautions (Procedure)

Posterior Approach Precautions

Other

This group receives precautions and have a total hip arthroplasty with a posterior approach.

干预措施: Posterior Approach Precautions (Procedure)

Anterior Approach No Precautions

Other

This group receives does not precautions and have a total hip arthroplasty with an anterior approach.

干预措施: No Precautions (Procedure)

Posterior Approach No Precautions

Other

This group receives does not receive precautions and have a total hip arthroplasty with a posterior approach.

干预措施: No Precautions (Procedure)

结局指标

主要结局

Change in Oxford Hip Score

时间窗: Week before surgery to 6 months after surgery

Assess function of the hip

次要结局

  • Canadian Patient Experience Survey - Inpatient Care (CPES-IC)(At 2 weeks after surgery)
  • Change in Tampa Scale for Kinesiophobia(Week before surgery to 6 months after surgery)
  • Change in Forgotten Joint Score(6 weeks after surgery to 6 months after surgery)
  • Change in EQ-5D-5L(Week before surgery to 6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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