VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

August 20, 2024 updated by: DEO NV

Comparison Between Velys Robotic-Assisted Solution (VRAS) and Conventional Surgery in Total Knee Arthroplasty: An Operational Excellence Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10

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: Aline BR Vandeputte, Msc.
  • Phone Number: +32469154039
  • Email: aline@deo.care

Study Contact Backup

  • Name: Jeroen Dille, Msc.
  • Phone Number: +32468290492
  • Email: jeroen@deo.care

Study Locations

  • United Kingdom
    • Ng5 8rx
      • Nottingham, Ng5 8rx, United Kingdom
        • Recruiting
        • Circle health group - BMI The Park hospital
        • Contact:
          • Benjamin Bloch, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The 10 participants of the study are orthopaedic surgeons. They will execute at least 5 conventional TKA procedures and at least 5 VELYS robot-assisted TKA procedures.

This study is observational, with a focus on operational excellence, and as such DEO.care will not influence surgeon's decisions with regards to surgical technique philosophies. Surgeon will select the relevant techniques for each case at his/her own discretion.

Description

Inclusion Criteria:

  • Orthopaedic surgeons performing conventional and robot-assisted TKA

Exclusion Criteria:

  • /

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Performing VELYS robot-assisted TKA
Surgeons performing VELYS robot-assisted TKA
Procedure: Robotic-assisted TKA
Robotic-assisted Total Knee Arthroplasty or total knee replacement is a surgical procedure using a robot to resurface a knee joint damaged with arthritis, and where the knee joint of the patient is replaced with a prosthesis.
Other Names:
  • DePuy Synthes, Velys Robotic-Assisted Solution
Performing conventional TKA
Surgeons performing conventional TKA
Procedure: Conventional TKA
Conventional Total Knee Arthroplasty or total knee replacement is a surgical procedure to manually resurface a knee joint damaged with arthritis, and where the knee joint of the patient is replaced with a prosthesis.
Other Names:
  • DePuy Synthes, Attune Knee System, Sigma Total Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operational efficiency
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ergonomic impaction - weight of trays
Time Frame: 3 months
Weight of trays will be measured to report ergonomic impaction of the team for the VRAS TKR compared to conventional TKR.
3 months
Ergonomic impaction - posture assessment
Time Frame: 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.
3 months
Total procedure cost
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DEO NV

Investigators

  • Study Director: Willem Franssen, Msc., DEOcare
  • Principal Investigator: Benjamin Bloch, M.D., Circle health group - BMI The Park hospital

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 (Estimated)

August 27, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VRAS

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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