NCT00969969已完成3 期
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 23
- 主要终点
- VAS, FAAM, Safety
研究概览
简要总结
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •≥ 18 years of age
- •Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis
- •Presence of good bone stock
- •Capable of completing self-administered questionnaires
排除标准
- •< 18 years of age
- •Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis
- •Active bacterial infection of the foot
- •Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)
结局指标
主要结局
VAS, FAAM, Safety
时间窗: up to 2 years
The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues.
次要结局
未报告次要终点
研究者
研究点 (23)
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