UK Multi-Centre, Observational, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 24
- 主要终点
- Primary Outcome Measure survivorship at 10 years
研究概览
简要总结
Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study Design 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 500 with 10 sites
详细描述
Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study Design 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 N Subjects 500 with 10 sites Follow-Up Schedule Subject enrollment will consist of a Pre-operative, Operative, 6 months, 1 yr., 2 yr., 5yr., 7 yr., 10 yr., and an unscheduled visit as needed.
Primary Objective Evaluate the long-term survivorship of the INFINITY® implant over 10 years
Secondary Objective(s) Secondary objectives assessed will be to:
- Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.
- Compare the improvements in self-reported pain and social interaction for quality of life measures from pre-op through 10 years post operatively; assessed by EuroQol (EQ5D5L).
- Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.
- Compare the improvement in self-reported pain-free function scores from pre-op through 10 years post-operatively, assessed by the Manchester Oxford Foot Questionnaire (MOXFQ) walking/standing scores.
- Identify and report the safety of the implant in terms of complications and adverse events.
Inclusion Criteria Subjects to be included in the study must meet all of the following criteria:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects to be included in the study must meet all of the following criteria:
- •Be 21 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 / witnessed verbal consent) Willing and able to attend the requested follow-up visits;
- •Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •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
Primary Outcome Measure survivorship at 10 years
时间窗: 10 Years
The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY® Total Ankle System performance/survivorship at up to 10 years.
次要结局
- Manchester Oxford Foot Questionnaire (MOXFQ)-questionnaire(From Pre-op through 10 years)
- Ankle Osteoarthritis Score (AOS)-questionnaire(From Pre-op through 10 years)
- EQ5D-EuroQol-questionnaire(From pre-op through 10 years)
- Radiographic evaluation-physician reported questionnaire(From Pre-op through 10 years)