A Prospective Randomized Trial Investigating the Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism and Respiratory Function During Intramedullary Nailing of Femoral Shaft Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Measurement of Embolic Debris
研究概览
简要总结
The purpose of this study is to determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures
详细描述
The current practice of reaming the medullary canal for the fixation of femur fractures is recommended, however, there is an associated increase in the level of embolic events which confers morbidity and, occasionally, mortality.
The RIA is a single device which is able to ream the medullary canal, irrigate the canal and subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and other contents responsible for these adverse embolic events.
A novel Reamer-Irrigator-Aspirator (RIA) (Synthes, Inc) will be evaluated in a randomized study, to determine its effect on the incidence of fat emboli events during reamed IM nail fixation of consecutive femoral shaft fractures as measured by intra-operative transesophageal echocardiogram and pulmonary function.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant aged 16 to 65 years of age
- •Skeletally mature
- •Isolated, closed femoral shaft fracture (participant may also have sustained a distal radius/wrist, distal tibia/ankle, hand, and/or foot fractures for eligible inclusion)
- •Fracture amenable to an antegrade I.M. nail
- •Fracture amenable to insertion of a 12 mm RIA
- •Fracture ≤ 48 hrs post injury
- •Participant has a 'Thorax' Abbreviated Injury Score (AIS) of < 2
- •Participant has a 'Head & Neck' AIS score of < 2
- •Provision of informed consent
排除标准
- •Fracture proximal to the lesser trochanter
- •Open fracture
- •Participant has a humeral, tibial, contralateral femoral, spinal,and/or pelvic fracture
- •Pathological fracture
- •Fractures > 48 hrs post injury
- •Limited life expectancy due to significant medical co-morbidities
- •Previous history of esophageal/gastric surgery
- •Previous history of esophageal/gastric tumor
- •Previous history of esophageal varices
- •Medical contraindication to surgery
结局指标
主要结局
Measurement of Embolic Debris
时间窗: Duration of surgical procedure.
The differences in total emboli score (Embolism Grading Scal3) between the 2 experimental groups were analyzed with a 2-sample 2-tailed t test. Embolism Grading Scale: Amount: Amount of right atrium fill by echogenic particles none = 0 less than ½ = 1 more than ½ = 2 complete fill = 3 Duration: Duration of echogenesis during 1-minute video segment (seconds) none = 0 less than 5 seconds = 1 5-30 seconds = 2 over 30 seconds = 3 Size: Diameter of largest echogenic particle (mm): none = 0 less than 5mm = 1 5-10mm = 2 larger than 10mm = 3 Percent: 0 =no fill 1. = less than 66 % 2. = greater than 66%
次要结局
未报告次要终点