Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 14
- 主要终点
- Safety: Monitoring frequency of AE, SAE and UADEs.
研究概览
简要总结
The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.
详细描述
The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder.
Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have previously participated in the Sidus IDE clinical trial.
- •Patient must not have undergone revision of the Sidus shoulder.
- •Patient must be able and willing to complete the protocol required follow-up.
- •Patient must be able and willing to sign the IRB/EC approved informed consent.
排除标准
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- •Patient did not previously participate in the Sidus IDE clinical trial.
- •Patient no longer has Sidus shoulder implanted.
结局指标
主要结局
Safety: Monitoring frequency of AE, SAE and UADEs.
时间窗: 10 Years
Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Implant Survival
时间窗: 10 Years
Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.
Performance: ASES Scores
时间窗: 10 Years
Will be determined by analyzing the ASES Questionnaire in subjects who received the Sidus Shoulder. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
次要结局
未报告次要终点