NCT02831244已完成不适用
Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Foot and Ankle Ability Measure (FAAM) score
研究概览
简要总结
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.
详细描述
Agili-C™ implant is a CE marked. The Agili-CTM implant is a porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.
The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •18 years or older
- •Osteoarthritis of the First Metatarsophalangeal Joint
- •Presence of good bone stock
- •Physically and mentally willing and able to comply with post-operative
- •rehabilitation and routinely scheduled clinical and radiographic visits
排除标准
- •< 18 years of age
- •Any past or present evidence of infection of the treated joint
- •Any known malignant tumor of the foot
- •Known inflammatory arthropathy or crystal-deposition arthropathy
- •Chemotherapy treatment in the past 12 months
- •History of allergic reaction or intolerance to calcium carbonate or hyaluronate
- •Patient who is pregnant or intends to become pregnant during the study
- •History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
- •Known substance abuse or alcohol abuse
- •Participation in other clinical trials in parallel to this study
- •Known insulin dependent diabetes mellitus
- •Unable to undergo imaging studies
结局指标
主要结局
Foot and Ankle Ability Measure (FAAM) score
时间窗: 24 month
FAAM score will be evaluated at 24 months compared to baseline
Visual Analog Scale (VAS) Pain
时间窗: 24 month
VAS will be evaluated at 24 months compared to baseline
次要结局
- Great toe range of motion(2 weeks, 6 weeks, 3, 6, 12 18 and 24 months)
- Pain according to Visual Analog Scale (VAS)(2 weeks, 6 weeks, 3, 6, 12 and 18 months)
- Activities of Daily Living Subscale according to Foot and Ankle Ability Measure (FAAM)(2 weeks, 6 weeks, 3, 6, 12 and 18 months)
- AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society-AOFAS)(2 weeks, 6 weeks, 3, 6, 12, 18 and 24 months)
- Measurament of Joint Space maintenance in mm(12 and 24 months)
- Quality of life questionnaire (SF-36)(6, 12, 18 and 24 months)
研究者
研究点 (4)
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