IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 27
- 主要终点
- Composite Safety Success Rate
研究概览
简要总结
This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.
详细描述
This is a registry database which will collect patient data as part of a physician's standard of care. Medical data will be collected on patients via questionnaires in either web based or paper forms. Both prospective and retrospective data will be entered into the database. Data collection will begin during the initial visit to the clinic. Demographic, surgical, hospital discharge, and adverse event data will be collected as well as patient reported outcomes including the PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) surveys. Patients will be asked to complete these surveys at the pre-operative and post operative visits at 75 days, 6 months, and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been deemed a candidate for the IlluminOss device
- •Patient is male or non-pregnant female
- •Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
- •Patient is willing and able to give informed consent if required
- •Traumatic patient is over the age of 50
- •IlluminOss procedure is the initial procedure to treat the traumatic injury
排除标准
- •United States (U.S.)
- •This product is contraindicated in U.S. patients who have:
- •an active or incompletely treated infection that could involve the site where the device will be implanted;
- •are allergic to any of the implant materials or to dental glue;
- •have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
- •distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
- •or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
- •European Union (EU)
- •This product is contraindicated in EU patients who have:
- •For all Bones:
- •Patients who are considered skeletally immature.
- •Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
- •Patients allergic to any of the implant materials, or to dental glue.
- •Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
- •Uncooperative patient or patient with neurologic disorder, incapable of following directions.
- •Distant foci of infections which may spread to the implant site.
- •Vascular insufficiency.
- •Open fractures with severe contamination.
- •Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- •Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
- •For acute Humerus fractures:
- •Patients who are under the age of Fifty (50)
- •For all bones excluding pathologic Humerus:
- •Metabolic disorders which may impair bone formation.
- •Osteomalacia.
- •Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
结局指标
主要结局
Composite Safety Success Rate
时间窗: 12 Months
次要结局
- Discharge Status(12 Months)
- Visual Analog Pain Score(12 Months)
- Fracture Healing(12 Months)
- Complications/Adverse Events(12 Months)
- Successful Device Implantation(12 Months)
- Disability & Return to Work Status(12 Months)
- Veterans Rand 12 Item Health Survey(12 Months)
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function(12 Months)