Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain at lag screw
研究概览
简要总结
Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. This study will help determine if implant related pain is different depending to the lag screw design.
详细描述
This study compares cephalomedullary fixation of intertrochanteric femur fractures using the Arthrex Hip Nail System with a telescoping lag screw compared to the Zimmer Natural Nail and the Smith and Nephew InterTan. This pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws The primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients greater than or equal to 22 years of age who undergo treatment of an intertrochanteric hip fracture with an intramedullary nail.
- •Fluoroscopic views of the final fixation construct or a post-operative radiograph taken within 24 hours must be available.
排除标准
- •Non-ambulatory prior to injury (patient must do more than only transfers)
- •Cognitive deficiencies that prevent the patient from providing their own informed consent
- •Inability to follow-up at the discretion of the investigator (incarceration, moving out of area, no permanent housing)
- •Prior fracture to injured hip
- •Prior surgery to injured hip
- •Basi-cervical fracture pattern (fracture that begins above the lesser trochanter and exits medial to the greater trochanter)
- •Patients not treated within 48 hours of admission
- •Chronic or acute infection at site of surgery
- •Language barrier preventing completion of study forms in English
- •Open fracture
- •Fracture related to neoplasm
结局指标
主要结局
Pain at lag screw
时间窗: 52 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
次要结局
- Radiographic lateralization of lag screw(52 weeks)
- Incidence of lag screw injections(52 weeks)
- Reoperation rate(52 weeks)