The Use Of A Fibular Intramedullary Nail For Fixation For Unstable Fibula Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays
研究概览
简要总结
The objective of this post-market clinical study is to evaluate efficacy outcomes and complication rates in patients who have received the Fibulock™ Intramedullary Nail.
详细描述
This is a retrospective/prospective, multi-site observational study, designed to evaluate the clinical outcomes and complication rates in subjects who were previously implanted with a Fibulock™ intramedullary nail.
Patients will be screened for eligibility and subgroupings. Informed consent will be obtained from those who meet screening criteria and are interested in participating in the study.
Sites will be asked to enroll subjects according to past treatment, with the Fibulock™ intramedullary nail for unstable fibula fracture. The sites will enroll subjects in the study based on inclusion/exclusion criteria.
Patient pre-operative, intra-operative and post-operative records will be reviewed retrospectively. Once enrolled, subjects will undergo an evaluation of fracture outcome and complete a VAS pain score, SF-12, and Foot Function Index at 26 weeks and again at 52 weeks post-treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An unstable fibula fracture.
- •Must be less than 31 weeks post-implantation
- •Must have received surgical treatment with the Fibulock Intramedullary Nail for their unstable fibula - fracture
- •Male or female greater than or equal to 18 years of age and skeletally mature.
- •Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
- •Ability to understand and provide written authorization for use and disclosure of personal health information.
排除标准
- •Patients who are not implanted with a Sonoma Fibulock IM Nail
结局指标
主要结局
Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays
时间窗: 26 weeks
Lateral and mortice view x-rays at 26 weeks
次要结局
- Visual Analog Scale(26 weeks and 52 weeks)
- Foot Function Index(26 weeks and 52 weeks)
- SF 12(26 weeks and 52 weeks)