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临床试验/NCT02093832
NCT02093832已完成不适用

Does the Femoral Head Size Can Predict the Cup Size? Retrospective Study.

HaEmek Medical Center, Israel2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.

研究概览

简要总结

This study had four aims:

  1. To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
  2. To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
  3. To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
  4. To suggest an additional online monitoring tool on the accuracy of the preoperative process and implant selection. We hypothesized that high accuracy rates will be found between the preoperative planned cup size and the actual implanted cup size. Furthermore, we hypothesized that strong correlations will be found between the planned and actual implanted cup size and the actual femoral head diameter size.

详细描述

Methods This is a retrospective study , that will include patients who underwent primary cementless THA due to end-stage hip osteoarthritis during 2011 and 2013 . Inclusion criteria were: Patients that underwent primary THA due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.

Data collection The following data will be collected: patients' characteristic including gender, age at surgery and side of surgery; implant information including cup model, planed cup size, actual cup size, shell type and outer diameter size (mm); actual femoral head diameter size (mm); the difference between the planned cup size and the actual cup size that was used; the difference between the actual femoral head diameter size measured at the end of surgery and the cementless implanted cup outer diameter size; the difference between the actual femoral head diameter size and the planed cup size..

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;

排除标准

  • Significant distortion in the femoral head.
  • Previous reconstructive surgery - radial osteotomy and hip socket.

结局指标

主要结局

To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.

时间窗: up to one year

次要结局

  • To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.(up to one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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