INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years
研究概览
简要总结
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up to 13 sites
详细描述
The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with up to 13 investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ With ADAPTIS™ Technology Total Ankle System.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Be over 22 years of age at the time of surgery;
- •Diagnosed with unilateral and/or bilateral ankle joint disease;
- •Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;
- •Willing and able to consent to participate (written, informed consent;
- •Willing and able to attend the requested follow-up visits;
- •A clinical decision has been made to use INFINITY™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment.
排除标准
- •Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;
- •Subjects requiring revision total ankle replacement of the ankle being considered for study
结局指标
主要结局
Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years
时间窗: 10 years
Assess the 10-year survivorship of 200 patients implanted with the INFINITY™ with ADAPTIS™ Technology Total Ankle System is non-inferior to other, similar devices.
次要结局
- PROMIS® Global Health Questionnaire(10 years)
- Ankle Osteoarthritis Score (AOS) Questionnaire(10 years)
- Patient Satisfaction of Total Ankle Replacement (TAR)(10 years)
- Radiographic Evaluation- Physician Reported Questionnaire(10 years)
- Foot & Ankle Observational Score (FAOS) questionnaire.(10 years)