NCT01331278已完成4 期
A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty
Foundation for Southwest Orthopedic Research4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- mean intraoperative time
研究概览
简要总结
The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.
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
- •must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
- •must be 18 years of age or older
- •must be capable and willing to provide informed consent
- •must have flexion contracture less than 15 degrees.
- •must have ligament stability no more than 2 degrees instability in varus/valgus extension stress
排除标准
- •medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
- •currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
- •known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
- •Knee alignment deformities greater than 7 degrees varus or valgus
- •known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
- •known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee
结局指标
主要结局
mean intraoperative time
时间窗: measured during surgery (day 1)
Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin.
次要结局
- alignment accuracy(3 weeks post-op)
研究者
研究点 (4)
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