FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Device-related Adverse Events and Device Deficiencies
研究概览
简要总结
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
详细描述
Study Title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study (Knee Spanning Kit and Damage Control Kit)
Sponsor: Zimmer Biomet
Study Design: Prospective enrollment, prospective follow-up, single cohort study
Clinical Phase: Postmarket
Number of Sites: Up to three sites
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
- •Patient must be 18 years of age or older
- •Patient must be treated with either the Knee Spanning or Damage Control FastFrame External Fixation System according to the European Economic Area (EEA) indications*
- •EEA Indications (a subset of the cleared US indications):
- •The FastFrame External Fixation System - Knee Spanning Kit is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
- •The FastFrame External Fixation System - Damage Control Kit is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
排除标准
- •Patient has an active or suspected infection
- •Patient has conditions that limit their ability and/or willingness to follow instructions during the healing process
- •Patient has inadequate skin, bone, or neurovascular status
- •Patient is a prisoner
- •Patient is pregnant and/or breastfeeding
- •Patient is a known current alcohol and/or drug abuser in the opinion of the Investigator
- •Patient has a mental or neurologic condition that will not allow for proper Informed Consent and/or participation in follow-up program in the opinion of the Investigator
研究组 & 干预措施
FastFrame External Fixation System - Knee Spanning or Damage Control Kit
The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.
干预措施: FastFrame External Fixation System - Knee Spanning or Damage Control Kit (Device)
结局指标
主要结局
Number of Participants With Device-related Adverse Events and Device Deficiencies
时间窗: 2-4 weeks postoperative
Frequency and incidence of device-related adverse events and device deficiencies before the FastFrame External Fixation System is exchanged by another device (i.e. plates, screws, etc.).
次要结局
- Number of Participants With Another Device-related Adverse Events(2-4 weeks postoperative)