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临床试验/NCT02074969
NCT02074969已完成不适用

Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
re-operation rate

研究概览

简要总结

The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).

详细描述

This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).

All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.

Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.

Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.

After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.

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
None

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

  • AO/OTA 31-A2 fractures
  • age between 18 - 100 years
  • Signed written informed consent and agreement to attend the planned FUs
  • Able to understand and read country national language at an elementary level

排除标准

  • missing informed consent form
  • pathological fracture
  • incomplete patient record
  • death within one month of intervention (surgery)
  • prior surgery to the hip
  • polytrauma
  • any additional fracture
  • any implant at the same hip
  • infection

研究组 & 干预措施

Gamma Nail 3

Active Comparator

Gamma Nail 3 Stryker.

干预措施: Gamma Nail 3 (Device)

PFNA

Active Comparator

PFNA Antirotation Synthes

干预措施: PFNA (Device)

结局指标

主要结局

re-operation rate

时间窗: time between intervention and one year after

次要结局

  • Screw-Cut Out(time between intervention and one year after)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harry Widhalm

M.D.

Medical University of Vienna

研究点 (2)

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