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临床试验/NCT04167787
NCT04167787Unknown不适用

Intelligent Operating Room (InOR) for Orthopaedic Surgery

Digital Surgery Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).

研究概览

简要总结

The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients 18-99 years.
  • All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).

排除标准

  • Patients/staff who are unwilling to participate in the study
  • Patients/staff that withdraw from the study
  • Two stage revisions for infected primary total knee replacements, multiple stage procedures for complex deformities,
  • Single stage revision procedures with the need for special instruments and modified steps
  • Patients with cognitive impairment/ special cognitive needs.
  • <18 years old

结局指标

主要结局

Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).

时间窗: 14 months

To determine how digital technologies and advanced data analytics can improve team coordination, efficiency and performance intraoperatively through understanding and mapping of surgical workflows and instrumentation use.

次要结局

  • Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets.(14 months)
  • To provide automatic post-operative analytics after each surgical operation (up to 150 cases).(14 months)

研究者

发起方
Digital Surgery Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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