Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of fracture nonunion
研究概览
简要总结
In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.
详细描述
Intertrochanteric femur fractures are a common injury pattern seen after acute hip trauma, with a very high rate of morbidity and mortality particularly among elderly patients. Cephalomedullary nail fixation has become a mainstay of treatment for both stable and unstable intertrochanteric fractures, offering greater stability than other options without replacing the native hip joint when possible. Despite this, the incidence of fracture nonunion remains high, resulting in poor functional outcomes, higher healthcare costs, and conversion to hemi- or total hip arthroplasty.
In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The Artemis PFN implant offers several purported advantages over existing implants. It is manufactured with a titanium core coated with carbon-fiber reinforced polyetheretherketone (PEEK), combining the strength of titanium with the bone-imitating biomechanical properties and radiolucency of PEEK. A number of additional features built into the Artemis System are designed to facilitate lower-complexity assembly/insertion, as well as reduce the likelihood of implant failure.
The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation
排除标准
- •Pediatric patients (<18 years)
- •Pregnant females
- •Patients with other concomitant orthopaedic injuries
结局指标
主要结局
Rate of fracture nonunion
时间窗: Up to 6 months
Rate of implant-related failure
时间窗: Up to 6 months
次要结局
- Fluoroscopy usage time(Intraoperative)
- Estimated blood loss(Intraoperative)
- Preoperative pain as assessed by a visual analog scale(30 days preoperatively)
- Preoperative function as assessed by the Functional Independence Measure(30 days preoperatively)
- Operative duration(Intraoperative)
- Discharge disposition(Perioperative, up to 6 months post procedure)
- Postoperative function as assessed by the Functional Independence Measure(Up to 6 months)
- Duration of hospital stay(Perioperative, up to 6 months post procedure)
- Postoperative complications(Up to 6 months)
- Postoperative pain as assessed by a visual analog scale(Up to 6 months)
- Financial costs(Intraoperative)
- Use of gait-aid device(Up to 6 months)
- Postoperative radiographic healing(Up to 6 months)
- Environmental costs(Intraoperative)