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临床试验/NCT04993053
NCT04993053已完成不适用

Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年6月20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
61
试验地点
1
主要终点
Fixation failure rate (cut-out or cut-through)

研究概览

简要总结

Intramedullary nailing is the standard treatment of trochanteric fractures. Mechanical failure such as cut-out and cut-through are associated with high rates of revision surgery, functional impairment and mortality. Augmentation of the implant have shown encouraging results in reducing the number of mechanical failures. The aim of the study was to evaluate the rate of mechanical failure of the cement augmented screws of TFNA nails.

A descriptive, retrospective, multi-operator, single-centre study was performed at our level 1 trauma centre. Patients were included if they were > 65 years of age, presented with a trochanteric fracture treated with an augmented TFNA nail. The primary outcome was fixation failure rate (cut-out or cut-through) at 3 and 6 postoperative months. Secondary endpoints were intraoperative data, clinical scores, and radiographic analysis.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 65 years of age
  • a trochanteric fracture that occurred through a low-energy mechanism
  • an augmented TFNA nail

排除标准

  • pathological fracture
  • open fracture
  • hips with pre-existing deformities other than osteoarthritis
  • a history of hip surgery
  • an insufficient quantity of injected cement (< 3 mL).

结局指标

主要结局

Fixation failure rate (cut-out or cut-through)

时间窗: change at 3 and 6 postoperative months

On X rays

次要结局

  • duration of hospitalisation(once)
  • EuroQoL 5-Dimensions score(change at 3 and 6 postoperative months)
  • length of surgery(at 3 and 6 postoperative months)
  • Harris Hip Score(at 3 and 6 postoperative months)
  • TFNA screw position(once)
  • the need for revision surgery(at 3 and 6 postoperative months)
  • analysis evaluating quality of reduction(once)
  • Augmentation volume(once)
  • radiation exposure(once)
  • Intraoperative adverse events(once)
  • Visual Analogue Scale score(at 3 and 6 postoperative months)
  • Parker Mobility Score(at 3 and 6 postoperative months)
  • distribution of cement on either side of the cervicocephalic screw(once)
  • postoperative complications(at 3 and 6 postoperative months)
  • the tip-apex distance(once)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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