FX Shoulder Solutions Retrospective / Prospective 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
- 2
- 主要终点
- Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
研究概览
简要总结
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
详细描述
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To 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.
Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study.
Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.
排除标准
- •Patient who does not meet the inclusion criteria above
结局指标
主要结局
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
时间窗: 10 years
* Adjusted Constant Score \> 70 * No continuous radiolucency or device migration/subsidence * No revision surgery or removal * No serious device related adverse event The Study will continue to follow patients prospectively to 10 years postoperative to track survivorship.
次要结局
- American Shoulder and Elbow Surgeon (ASES)(3, 6, 12, 24 months, 5 and 10 years.)
- Range of Motion(3, 6, 12, 24 months, 5 and 10 years.)
- Number of Participants with Radiographic Reviews and Assessments.(24 months, at 5 years and 10 years postoperative)
- Number of Participants Who Have a Secondary Surgical Intervention (SSI)(24 months and at 5 and 10 years)
- Serious Adverse Device Effects (SADE)(24 months and at 5 and 10 years postoperative.)
- Adjusted Constant Score(3, 6, 12, 24 months, 5 and 10 years.)
- QuickDASH(3, 6, 12, 24 months, 5 and 10 years.)
- Visual Analog Scale (VAS). A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length.(3, 6, 12, 24 months, 5 and 10 years)
- Device Related Adverse Events.(24 months and at 5 and 10 years postoperative)
- Serious Adverse Event(24 months and at 5 and 10 years postoperative)