NCT02408471终止不适用
Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 18
- 主要终点
- Number of Participants With Revisions
研究概览
简要总结
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indications consistent with the FDA approved Indications For Use: Index, long, ring, or small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization
- •Willing to participate in the study
- •Signed an Informed Consent Form
- •The means and ability to return for all required study visits
- •Are not transient
排除标准
- •Patients who have any of the following contraindications will be excluded from the study:
- •Inadequate bone stock at the implantation site
- •Active infection in the MCP joint
- •Nonfunctioning and irreparable MCP musculotendinous system
- •Physical interference with or by other prostheses during implantation or use
- •Procedures requiring modification of the prosthesis
- •Skin, bone, circulatory and/or neurological deficiency at the implantation site
结局指标
主要结局
Number of Participants With Revisions
时间窗: 12 months
Count of participants with a revision surgery.
次要结局
- Change in Grip Strength(Preoperatively to 12 months)
- Change in Tip Pinch(Preoperatively to 12 months)
- Function Visual Analog Scale (VAS)(Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months)
- Change in Joint Range of Motion(Preoperatively to 12 months)
- Change in Radial-Ulnar Deviation(Preoperatively to 12 months)
- Joint Position(Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months)
- Component Migration(6 Weeks, 12 Weeks, 6 Months, 12 Months)
- Joint Pain Visual Analog Score (VAS)(Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months)
- Cosmetic Appearance Visual Analog Scale (VAS)(Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months)
- Bone Changes by Device(6 Weeks, 12 Weeks, 6 Months, 12 Months)
研究者
研究点 (18)
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