跳至主要内容
临床试验/NCT03825029
NCT03825029Unknown不适用

Can the Difference Between the Operative and Radiographic Cup Inclination Angle Be Reduced by Applying a Pillow Between the Patient's Legs in Total Hip Arthroplasty Performed In The Lateral Decubitus Position?

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change in radiographic cup inclination angle

研究概览

简要总结

The purpose of this study is to find out whether placing a pillow between the legs during hip surgery will result in a better aligned hip replacement.

详细描述

During hip replacement surgery the cup is placed on specific planned angles. Cup placement has an effect on the patients' pain-free range of movement, dislocation rates and satisfaction. However, the angles of the cup orientation (i.e. the tilt and rotation), which are preoperatively planned and postoperatively measured on radiographs, have a high variability even when an experienced surgeon is performing the surgery. One of the reasons this occurs is because the operated leg can move the pelvis to a different position in the time between set-up and actual implantation which may lead to the cup being placed in a non-optimal position. This study aims to see if the difference between planned and achieved cup angles and pelvic movement can be lessened by putting a pillow in between the legs to keep it in a stable horizontal position.

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

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

  • Patient awaiting primary total hip arthroplasty using a posterior approach in a lateral decubitus position
  • Patients capable of reading, understanding, and willing to sign the informed consent form

排除标准

  • Total hip arthroplasty not using a posterior approach in a lateral decubitus position
  • Prior hip osteotomy or fracture osteosynthesis on the index hip

结局指标

主要结局

Change in radiographic cup inclination angle

时间窗: Intra-operatively and post-operatively (within one month after the surgery)

The difference between the operative and postoperative radiographic cup inclination angle

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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