A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Demographics and Medical History
研究概览
简要总结
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.
详细描述
Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.
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Demographics and Medical History
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Pre & Post-Operative Data including Range of Motion
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Surgical Data
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Survivorship (phone/email or last known visit)
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Patient Reported Outcomes (phone/email single time point visit)
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Patient Satisfaction
-
KOOS Jr.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
- •Over 18 Years of age
排除标准
- 未提供
结局指标
主要结局
Demographics and Medical History
时间窗: 1 year
Demographics and medical history gathered from medical records
Pre and Post Operative Range of Motion
时间窗: 1 year
Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits
次要结局
未报告次要终点