BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Number of Participants With Device Associated Adverse Events
研究概览
简要总结
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
详细描述
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients 18 years of age or older
- •Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
- •Patients willing and able to comply with the requirements of the study protocol and provide informed consent.
排除标准
- •Patients with active or latent infection
- •Patients with decreased vascularity
- •Patients with pathological soft tissue conditions
- •Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
- •Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
- •Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager
结局指标
主要结局
Number of Participants With Device Associated Adverse Events
时间窗: 12 Months
The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.
次要结局
- Clinical Functional Outcome - Adjusted Constant-Murley Score(12 Month)
- Number of Study Participants With Re-tears(12 Months)
- Clinical Functional Outcome - WORC Index(12 Months)