Pyrocarbon Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 8
- 主要终点
- Change from Baseline to last follow-up visit in ASES scores
研究概览
简要总结
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort.
Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject in the Pyrocarbon IDE Study and has not had the device explanted.
- •Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
- •Willing and able to comply with the requirements of the study protocol
排除标准
- •Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
结局指标
主要结局
Change from Baseline to last follow-up visit in ASES scores
时间窗: Follow-up visits through 10 years Post-Op
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
次要结局
- Change from Baseline to last follow-up visit in Constant Murley scores(Follow-up visits through 10 years Post-Op)
- Change from Baseline to last follow-up visit in EQ-5D scores(Follow-up visits through 10 years Post-Op)
- Number of device associated and procedure associated adverse events.(Follow-up visits through 10 years Post-Op)
- Change from Baseline to last follow-up visit in SANE scores(Follow-up visits through 10 years Post-Op)
- Change from Baseline to last follow-up visit in Subject Satisfaction scores(Follow-up visits through 10 years Post-Op)
- Evaluation of operated shoulder range of motion(Follow-up visits through 10 years Post-Op)
- Rates of revision surgeries.(Follow-up visits through 10 years Post-Op)