NCT05179005终止不适用
Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of re-operation
研究概览
简要总结
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone
详细描述
Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age, male or female
- •Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures
- •Minimum amount of follow-up data available, including one visit post-surgery
- •Willing and able to sign an Informed Consent for research
- •Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery
排除标准
- •Latent or active infection with positive culture at the time of implantation
- •Documented history of metal sensitivity
- •Documented psychiatric condition preventing the patient from following post-op care instructions
- •Fixation of the first and/or second (true) vertebrosternal rib
- •Bilateral rib fractures
- •Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization
- •Lung injury (open pneumothorax, tension pneumothorax, hemothorax > 1L, pulmonary contusion requiring mechanical ventilation)
结局指标
主要结局
Rate of re-operation
时间窗: 3 months post-op
Number of subjects who needed surgical re-intervention related to rib fracture repair
次要结局
- Length of stay in hospital(Day 0 (surgery) to Day 7)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic DeviceRib Fracture MultipleNCT04163224Zimmer Biomet
已完成
不适用
Effectiveness Of The Fibulock Intramedullary NailFibula FractureNCT02688296Arthrex, Inc.34
终止
不适用
Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical StudySenile PtosisNCT03055819Zift, LLC20
已完成
不适用
BioWick SureLock Clinical Outcomes StudyRotator Cuff TearNCT03199391Zimmer Biomet71
终止
不适用
FibroFix Cartilage P Knee Implant StudyOsteoarthritis, KneeNCT05560490Orthox Limited2