NCT02452957撤回不适用
A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
Stryker Trauma and Extremities1 个研究点 分布在 1 个国家开始时间: 2020年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of patients with device related adverse events as a measure of safety
研究概览
简要总结
The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
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
- •A subject must meet all of the following inclusion criteria in order to enter the study:
- •Adult subject 18 years or older,
- •Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
- •Scapula and proximal humerus must have reached skeletal maturity,
- •Willing and able to comply with the protocol,
- •Willing and able to personally sign the informed consent form,
- •Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.
排除标准
- •A subject will not be eligible to participate in the study if any of the following conditions is present:
- •lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
- •Severe Walch grade B2 glenoid defined as >60% posterior head displacement and >20% posterior glenoid bone loss,
- •metal allergies or sensitivity,
- •infection at or near the site of implantation,
- •distant or systemic infection.
结局指标
主要结局
Number of patients with device related adverse events as a measure of safety
时间窗: 24 months
All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.
次要结局
- Change in the DASH Score as a measure of improvement in the patients' Quality of Life(24 months)
- Change in the Range of Motions (ROM) as a measure of effectiveness(24 months)
- Change in humeral cortical thickness as an evaluation of Stress Shielding(24 months)
- Change in the Constant Score as a measure of effectiveness(24 months)
研究者
研究点 (1)
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