VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

Recruiting

• Conditions: Total Knee Arthroplasty (TKA)
• Interventions: Procedure: Robotic-assisted TKA; Procedure: Conventional TKA

• Registration Number: NCT06563843
• Lead Sponsor: DEO NV

Brief Summary

The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.

Detailed Description

The increasing number of total knee arthroplasty (TKA) procedures is putting a significant burden on healthcare systems, surgeons and their surgical teams. Technology is introduced to improve accuracy, reproducibility and efficiency of TKA surgery, and a significant portion of the patient population is now being treated using Robotic Assisted Surgery. However, robotic surgeries are believed to have a longer procedure time.

The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.

In this multicentre study, measurements will be conducted in 10 hospitals with 10 selected surgeons across selected countries in Europe and the UK. For each surgeon enrolled, a minimum of five VRAS assisted surgical procedures and five conventional surgical procedures will be observed. The OR set-up will be similar for all cases in the same hospital. The same experienced surgeon will conduct all procedures.

Study Timeline

• Study First Submitted: 2024-07-17
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Study Start: 2024-08-27
• Primary Completion: 2025-11
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Orthopaedic surgeons performing conventional and robot-assisted TKA

Exclusion Criteria

• /

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Performing VELYS robot-assisted TKA	Robotic-assisted TKA	Surgeons performing VELYS robot-assisted TKA
Performing conventional TKA	Conventional TKA	Surgeons performing conventional TKA

Primary Outcome Measures

Name	Time	Method
Operational efficiency	3 months	Efficiency will be assessed using OR time, by comparing the OR days and procedures where TKR is performed conventionally or by using VRAS surgery.; A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts.

Secondary Outcome Measures

Name	Time	Method
Total procedure cost	3 months	The procedure cost differences between VRAS TKR and conventional TKR will be calculated using activity based costing modeling. This model will include fixed direct, fixed indirect, and variable costs, tailored to each country's local cost parameters and healthcare financing models.
Ergonomic impaction - weight of trays	3 months	Weight of trays will be measured to report ergonomic impaction of the team for the VRAS TKR compared to conventional TKR.
Ergonomic impaction - posture assessment	3 months	Surgeon's posture assessment using RULA and REBA method will be executed to report ergonomic impaction for the VRAS TKR compared to conventional TKR.

Trial Locations

Locations (1)

Circle health group - BMI The Park hospital; 🇬🇧 Nottingham, Ng5 8rx, United Kingdom