跳至主要内容
临床试验/NCT04180423
NCT04180423终止不适用

What Factors Affect Operating Room Efficiency When Performing TKA Using Customized Implant Techniques: Conformis iTotal (CR), (PS)

Restor3D1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
59
试验地点
1
主要终点
Operating Room Efficiency

研究概览

简要总结

This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • > 18 years of age

排除标准

  • Participation in another clinical study which would confound results
  • Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
  • Simultaneous bilateral Total Knee Arthroplasty cases

结局指标

主要结局

Operating Room Efficiency

时间窗: Single time point - day of surgery

Surgeon questionnaire to determine operating room efficiency from the 1st to the 50th iTotal implant performed and to determine any differences that might exist between operating room efficiency between the iTotal surgery and baseline metrics when performing OTS implant surgery

次要结局

未报告次要终点

研究者

发起方
Restor3D
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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