跳至主要内容
临床试验/NCT06357312
NCT06357312Unknown不适用

Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail

Elda University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Evaluation of functional status using the Barthel index

研究概览

简要总结

Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.

详细描述

Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Blinding of the patient included in the study and the investigator evaluating the results

入排标准

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

入选标准

  • Patient over 50 years old
  • With unstable intertrochanteric hip fracture
  • Operated in the first 48 hours after hospital admission

排除标准

  • Simultaneous associated fractures
  • Fractures with subtrochanteric line
  • Non-acute fractures

结局指标

主要结局

Evaluation of functional status using the Barthel index

时间窗: 12 months

Evaluation of functional status 12 months after hip surgery

次要结局

  • Postoperative mechanical complications(12 months)
  • Parker mobility scale(12 months)

研究者

发起方
Elda University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Antonio Miralles-Muñoz

Head of Department of Orthopedic Surgery

Elda University Hospital

研究点 (2)

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