NCT04912908已完成不适用
Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
Ganymed Robotics1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Validation of navigation algorithm
研究概览
简要总结
Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.
详细描述
During knee replacement surgery, per-operative images of the patient's knee will be taken. These images will then be compared with the pre-operative CT-scan of the patient using the novel navigation algorithm. The algorithm will be validated based on its ability to correctly compare both modalities (pre-operative and per-operative images).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Adults patients who signed the ICF of the study
- •Patients suffering from knee osteoarthritis requiring a total knee replacement surgery
排除标准
- •Patient under the age 18
- •Patient unable to consent to the study or refusing to participate
- •Patient with history of knee replacement on the knee that will be operated again
- •Patient unable to realize a pre-operative CT-scan
- •Patient not covered by French Health insurance or equivalent.
结局指标
主要结局
Validation of navigation algorithm
时间窗: 12 months
Comparison between peroperative images and preoperative CT-scan
次要结局
未报告次要终点
研究者
研究点 (1)
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