Intelligent Operating Room (InOR) for Orthopaedic Surgery
InOR
1 other identifier
observational
150
1 country
1
Brief Summary
The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2019
CompletedFirst Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2020
CompletedNovember 20, 2019
November 1, 2019
1.1 years
October 18, 2019
November 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).
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.
14 months
Secondary Outcomes (2)
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
Eligibility Criteria
-Adult patients undergoing elective total and unicondylar knee replacement.
You may qualify if:
- Adult patients 18-99 years.
- All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Digital Surgery Ltd.lead
- University College London Hospitalscollaborator
Study Sites (1)
University College London Hospital NHS Trust
London, NW1 2BU, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
November 19, 2019
Study Start
October 10, 2019
Primary Completion
December 2, 2020
Study Completion
December 2, 2020
Last Updated
November 20, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share