- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167787
Intelligent Operating Room (InOR) for Orthopaedic Surgery (InOR)
November 18, 2019 updated by: Digital Surgery Ltd.
The objective of the study is to evaluate the usefulness of digital technologies to support surgical teams before, during, and after an operation.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen Kerr, Dr
- Phone Number: 07967135052
- Email: karen.kerr@touchsurgery.com
Study Locations
-
-
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London, United Kingdom, NW1 2BU
- Recruiting
- University College London Hospital NHS Trust
-
Contact:
- Nachappa Sivanesan Uthraraj
- Email: nachappa.uthraraj@nhs.net
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
-Adult patients undergoing elective total and unicondylar knee replacement.
Description
- Inclusion Criteria:
- Adult patients 18-99 years.
- All willing patients undergoing elective total and unicondylar knee replacement (both navigated and robotic-assisted).
- Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline scores of qualitative questionnaires (every 8 weeks in one surgical team).
Time Frame: 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.
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets.
Time Frame: 14 months
|
Assessed through monitoring scores from qualitative questionnaires of the surgical team;
|
14 months
|
To provide automatic post-operative analytics after each surgical operation (up to 150 cases).
Time Frame: 14 months
|
Including phase timings and instrumentation
|
14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2019
Primary Completion (Anticipated)
December 2, 2020
Study Completion (Anticipated)
December 2, 2020
Study Registration Dates
First Submitted
October 18, 2019
First Submitted That Met QC Criteria
November 14, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ULCH DS 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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