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

Study Locations

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

Digital Surgery Ltd.

Collaborators

University College London Hospitals

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.

Clinical Trials on Knee Replacement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe