A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Radiation Exposure Measurement
研究概览
简要总结
The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.
详细描述
The TRIGEN SURESHOT™ Distal Targeting System was designed to be an intraoperative image-guided localization system to aid with drill positioning for screws during intramedullary nailing distal interlocking. It is hypothesized that this system will aid in identification of the distal holes leading to reduced exposure to radiation. The SURESHOT System provides information to the surgeon that is used to place surgical instruments utilizing electromagnetic tracking data obtained intraoperatively. It is indicated for long bone fractures treated with intramedullary nailing in which the use of stereotactic surgery may be appropriate. The hypothesis is that using the TRIGEN SURESHOT™ Distal Targeting System will allow accurate distal locking while effectively decreasing the amount of radiation exposure compared to the standard instrumentation process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate.
- •Subject is between 18-80 years of age.
- •Subject is skeletally mature
- •Subject is of legal age and capable of providing legal consent.
- •Subject is suitable for current Intramedullary Nailing procedure
- •Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation.
排除标准
- •Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate.
- •Fracture with vascular injury (Gustilo Type IIIC) requiring repair
- •Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement).
- •Fracture of the Metaphyseal distal femur with intraarticular comminution
- •Known Pathological Fracture
- •Subject is a prisoner
- •Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures
- •Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator.
- •Contralateral femoral shaft fracture
研究组 & 干预措施
TRIGEN SURESHOT Distal Targeting
TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
干预措施: TRIGEN SURESHOT Distal Targeting Instrumentation. (Device)
Standard Nailing Instrumentation.
Free-hand technique utilizes x-rays to find screw holes
干预措施: Free-hand technique (Other)
结局指标
主要结局
Radiation Exposure Measurement
时间窗: Intraoperative
Radiation exposure measured in two ways: Whole body badge TLD ring badge
次要结局
- Distal Locking Time(Intraoperative)