Intelligent Operating Room (InOR) for Orthopaedic Surgery

Knee Replacement Clinical Trial

— InOR  

Official title:

Intelligent Operating Room (InOR) for Orthopaedic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167787
• Other study ID #: ULCH DS 001
• Status: Recruiting
• Start date: October 10, 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: November 2019
• Source: Digital Surgery Ltd.
• Contact: Karen Kerr, Dr
• Phone: 07967135052
• Email: karen.kerr[@]touchsurgery.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Knee Replacement
• Musculoskeletal

Locations

Country	Name	City	State
United Kingdom	University College London Hospital NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Digital Surgery Ltd.	University College London Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Report the effect of presenting information intraoperatively through digital displays and augmented reality headsets.	Assessed through monitoring scores from qualitative questionnaires of the surgical team;	14 months
Secondary	To provide automatic post-operative analytics after each surgical operation (up to 150 cases).	Including phase timings and instrumentation	14 months