FX Shoulder Post-Market Follow-Up Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):
研究概览
简要总结
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
详细描述
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.
To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.
To provide data and analysis for presentations, abstracts, publications and other public release of results.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
- Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline
- No continuous radiolucency or device migration/subsidence
- No revision surgery
- No serious device related adverse event
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
排除标准
- •Patient who does not meet the inclusion criteria.
研究组 & 干预措施
Subjects
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
干预措施: FX Artificial Shoulder Prosthesis (Device)
结局指标
主要结局
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):
时间窗: 2 years
Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline. No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event.
Survivorship
时间窗: 10 years
Follow patient's post-operative to track survivorship.
次要结局
- Adjusted Constant Score(6 weeks, 3, 6, 12, and 24 months.)
- QuickDASH(6 weeks, 3, 6, 12, and 24 months.)
- Visual Analog Scale (VAS).(6 weeks, 3, 6, 12, and 24 months)
- Secondary Surgical Interventions (SSI)(24 months and at 5 years postoperative)
- Serious Adverse Event(24 months and at 5 years postoperative)
- Serious Adverse Device Effects (SADE)(24 months and at 5 years postoperative.)
- Range of Motion (ROM)(6 weeks, 3, 6, 12, and 24 months)
- Radiographic Reviews and Assessments.(24 months and at 5 years postoperative.)
- American Shoulder and Elbow Surgeon (ASES)(6 weeks, 3, 6, 12, and 24 months)
- Survival(24 months and at 5 years)