Intelligent Operating Room (InOR) for Orthopaedic Surgery

• Conditions: Musculoskeletal; Knee Replacement

• Registration Number: NCT04167787
• Lead Sponsor: Digital Surgery Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-10-18
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-12-02
• Study Completion: 2020-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College London Hospital NHS Trust; 🇬🇧 London, United Kingdom