跳至主要内容
临床试验/NCT04094935
NCT04094935Unknown不适用

Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Screws exceeding the posterior cortical

研究概览

简要总结

Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.

The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)

详细描述

  • Preoperative consultation

  • Oral information of the patient of the protocol and delivery of the written information note

  • Seeking patient's non-opposition to participating in the study

  • Inclusion of the patient

  • Surgical procedure for distal radius fracture + immediate post-operative radiography

  • Intervention performed according to the usual practices of the service by the surgeon of the day without randomization

  • Radiography: 2 shots: face and wrist profile

  • Control X-ray + consultation

  • Achieved at 3 weeks, 6 weeks and 3 months after the intervention

  • X-rays: 2 shots: face and wrist profile

  • Control ultrasound o Realized at 3 months after the intervention

End of participation in the study after consultation of 3 months.

研究设计

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

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

  • Age ≥ 18 years old
  • Fracture (s) of extra joint distal radius with or without joint refend in the sagitta plane
  • Osteosynthesis by anterior locked plate
  • Patient who did not oppose his participation in this research

排除标准

  • Distal radius fractures with joint refend frontal (posterior marginal)

结局指标

主要结局

Screws exceeding the posterior cortical

时间窗: 3 months

Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.

次要结局

  • Tendon complications(3 months)
  • Secondary displacement or dismantling(3 months)
  • Ablation of material or resumption early surgery(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验