跳至主要内容
临床试验/NCT04623073
NCT04623073已完成不适用

The External Obturator Footprint as a Landmark for Stem Dept - Clinical Validation

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年1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
135
试验地点
1
主要终点
Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs

研究概览

简要总结

One of the goals of Total Hip Arthroplasty (THA) is to reconstruct leg length as adequately as possible. In order to achieve this one needs landmarks that are visible both on the templating X ray as well as during surgery. The classical posterior and lateral approaches often rely on the distance from the greater trochanter (GT) to the shoulder of the femoral stem or the distance from the lesser trochanter (LT) to the side of the neck osteotomy. If the surgeon finds out on the digital template that the distance from the GT to the shoulder of the implant should be X mm to achieve equal leg length, than the surgeon can try to reconstruct this during surgery. During the Direct Anterior Approach (DAA) these landmarks usually are not visible or require additional dissection injuring important soft tissue structures along the way. One anatomical structure that appears to be always visible during the DAA is the External Obturator tendon (EO). It was recently confirmed that the level of insertion of the EO onto the proximal femur can also always be determined on pre-operative X rays. It therefore represents one of the few landmarks that is visible both on the templating X ray as well as during DAA THA. Indeed, many hip surgeons, including ourselves, believe that if the shoulder of the femoral stem is near the insertion of the EO leg length cannot be far off. However, there is no clinical data to support this. The investigators would therefore like to the correlate the distance observed intra-operatively to the actual established distance on the post-operative X ray.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon

排除标准

  • Distance not noted
  • No radiographs available

结局指标

主要结局

Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs

时间窗: 2 days

次要结局

  • Visibility of the EO tendon intra-operatively(2 days)
  • Inter and intra-rater reliability(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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