Patient Specific Talus Spacer Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Paragon 28
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
研究概览
简要总结
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
详细描述
This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
- •Avascular necrosis of the ankle joint;
- •Age 21 years old or older;
- •Subject has good general health; and
- •Subject signs a written informed consent form (ICF) prior to the surgical procedure.
排除标准
- •Presence of any contraindication identified in the device Instructions for Use;
- •Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
- •Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
- •For female subjects, pregnancy;
- •Active systemic disease, such as AIDS, HIV, or active infection;
- •Active infection or the skin is compromised at the surgical site; and
- •Systemic disease that would affect the subject's welfare;
- •Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
- •Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up.
- •If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient.
- •If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.
结局指标
主要结局
A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
时间窗: A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.
A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
时间窗: At 5 years compared to Baseline
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.
次要结局
- Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.(5 Years Post Procedure compared to baseline.)