Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Survivorship of Salto Talaris Ankle Implant
研究概览
简要总结
This post market outcome study will look at the therapeutic results of the Salto Talaris Anatomic ankle prosthesis. The study population will consist of patients who will undergo an ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be conducted of the results, complications and revisions of this prosthesis based on the etiology for which the ankle arthroplasty was performed.
详细描述
This is a prospective, multi-center study that will capture the therapeutic results of the Salto Talaris Anatomic ankle prosthesis in the treatment of various ankle afflictions.
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
- •Subjects that need an ankle joint replacement due to arthritis or failed prior fusion.
- •Subjects who have failed standard conservative management of their ankle condition
排除标准
- •Class IV or higher anesthetic risk
- •Subjects who are not able to comply with the study procedures
- •Known contraindications to joint replacement such as active infection, complete talar necrosis, insufficient quality of bone stock, ligament laxity, severe osteopenia, Charcot's arthropathy
- •Unwilling to be followed for 5 years
结局指标
主要结局
Survivorship of Salto Talaris Ankle Implant
时间窗: 10 years
Count of participants without a failed ankle arthroplasty. Ankle arthroplasty will be considered as failed if the implant is revised or removed and the ankle fused.
次要结局
- The American Orthopaedic Foot and Ankle Society (AOFAS) Score(Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)