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临床试验/NCT02190435
NCT02190435已完成不适用

Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures

William Beaumont Hospitals2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Tip-to-apex Distance

研究概览

简要总结

There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has become a well-accepted and increasingly more common procedure among orthopaedic traumatologists, and is standard of care at our institution.

While advancements in intramedullary nail fixation have made it a relatively efficient procedure, the placement of the lag screw into the femoral head still remains a challenging step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most commonly reported complications with IM nail fixation. Previous work has shown that the lag screw position is an important factor in reducing screw cut-out. This step of the procedure can be time demanding and often requires several intraoperative radiographs for accurate placement. Recently developed computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved screw placement and potentially reduce radiation exposure to the patient and surgeon. To date, the potential advantages of computer-assisted navigation have not been examined.

The primary objective of this study is to examine whether the use of Stryker's ADAPT computer-assisted navigation for Gamma nail fixation can result in improved lag screw placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a difference in the lag screw placement (i.e. tip to apex distance measurement) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation. Additionally, we hypothesize that there is a difference in radiation exposure (i.e. fluoroscopy time) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.

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

  • Patients undergoing hip fracture fixation with a Gamma Nail by one of four orthopaedic trauma surgeons at William Beaumont Hospital Royal Oak
  • Diagnosis of an intertrochanteric femur fracture (AO Classification 31-A1,A2)
  • Low energy mechanism of injury (i.e. fall, twist)

排除标准

  • Minors (less than 18 years)
  • Have a high energy mechanism of injury (e.g. motor vehicle accident, fall from height)
  • Have an open fracture (i.e. the skin is broken at the fracture site), or
  • Present with multiple injuries to the ipsilateral lower extremity

结局指标

主要结局

Tip-to-apex Distance

时间窗: Intraoperative

Distance between lag screw tip and head surface as measured on the ADAPT system

次要结局

  • Radiation Exposure(Intraoperative)

研究者

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

Kevin Grant, MD

Principal Investigator

William Beaumont Hospitals

研究点 (2)

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