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临床试验/NCT04587440
NCT04587440
Unknown
不适用

Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 53 人2021年2月2日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Coxarthrosis; Primary
发起方
University Hospital, Brest
入组人数
53
试验地点
1
主要终点
Variation of the pelvic incidence
最后更新
4年前

概览

简要总结

Total hip replacement is one of the most common surgical procedure in France. In 2010, an estimated 147 513 total hip procedures were performed. This number is constantly increasing.

Although it is common, it can lead to many complications. The intra-prosthetic luxation is the second one after aseptic loosening.

The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components. This orientation is influenced by statics and dynamics parameters.

So far, the literature shows that only static parameters are considered by surgeons. Thus, in reference to Lewinneck publication, which states that the luxation risk is lower if the cup is oriented with 15° +/- 10° of anteversion and 40°+/- 10° of inclination with respect to the anterior pelvic plan (APP). Defined by the two anterosuperior iliacs spines and pubic symphysis.

However, this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life.

To consider these variations of pelvic inclination, it is possible to measure the angle between APP and the horizontal (in lying position) or the vertical (in standing position) plan.

Several devices allow the measure of pelvic inclination but they all have important limits (EOS radiography, scanner or navigation). A new device has been developed in Brest to measure this inclination in several positions of the daily life.This software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility.

The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device, and to assess the amount of variation induced by hip replacement procedures.

注册库
clinicaltrials.gov
开始日期
2021年2月2日
结束日期
2023年8月2日
最后更新
4年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 未提供

排除标准

  • Patient Under 18
  • Patient Under protective measure (guardianship, curatorship) or unable to consent
  • Patient requiring revision THR
  • Patient with geographic mobility plan before the end of the follow-up
  • Symptomatic contralateral hip
  • Symptomatic dorsolumbar rachis
  • Pelvis or spine surgery planed during the follow-up
  • Pregnant or nursing woman

结局指标

主要结局

Variation of the pelvic incidence

时间窗: Day 0 - Month 3

The main evaluation criterion is the variation of the pelvic incidence between pre- and post-operative total hip replacements

次要结局

  • Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Harris hip score)(Day 0 - Month 3)
  • Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (EVA)(Day 0 - Month 3)
  • Analysis of the correlation between the variation in pelvic incidence while sitting, standing and lying down and the implant settings(Day 0 - Month 3)
  • Analysis of the correlation between variation in pelvic incidence while sitting, standing and lying down and clinical parameters (Hand-ground distance)(Day 0 - Month 3)

研究点 (1)

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