Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
The purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a period of 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Eighteen (18) or older
- •Known to have ankle arthritis for more than six (6) months
- •Tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved
- •Patient tests (questionnaires) show that ankle arthritis is severe
- •Patient willing to take part in the study, including signing consent form after carefully reading it
排除标准
- •Dead Bone in the Ankle
- •Severe foot or Ankle Deformity
- •Prior Ankle Fusion or Replacement
- •Active or Prior Infection in the Ankle
- •Obesity (greater than 250 lbs)
- •Medical Conditions precluding safe surgery
- •Nerve or Muscle disease
- •Severe osteoporosis
研究组 & 干预措施
Ankle Arthroplasty
干预措施: Ankle Arthroplasty (Procedure)
Ankle Artrodeses
干预措施: Ankle Arthrodesis (Procedure)
结局指标
主要结局
Complications
时间窗: 10 years
Radiographs
时间窗: 10 years
AAOS Foot and Ankle Questionnaire - includes SF-36
时间窗: 10 years
Ankle Osteoarthritis Scale
时间窗: 10 years
AOFAS Ankle-Hindfoot Scale
时间窗: 10 years
Foot Function Index
时间窗: 10 years
次要结局
未报告次要终点