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NCT Number: NCT06563843

VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

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.

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Key information

Conditions

Total Knee Arthroplasty (TKA)

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Circle health group - BMI The Park hospital

Nottingham, NG5 8RX, United Kingdom

Location status: Recruiting

Location contact

Benjamin Bloch, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Orthopaedic surgeons performing conventional and robot-assisted TKA

Exclusion criteria

  • /

Treatment and study plan

Robotic-assisted TKA

Procedure

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

Conventional TKA

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aline BR Vandeputte, Msc.

CONTACT

[email protected]

+32469154039

Jeroen Dille, Msc.

CONTACT

[email protected]

+32468290492

Sponsors and collaborators

Lead sponsor

DEO NV

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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