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Recruiting NCT06563843

VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

Observational Total Knee Arthroplasty (TKA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic-assisted TKA, Conventional TKA.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty (TKA). Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Operational efficiency [Time frame: 3 months]
Secondary outcome measures (3)
  • Ergonomic impaction - weight of trays [Time frame: 3 months]
  • Ergonomic impaction - posture assessment [Time frame: 3 months]
  • Total procedure cost [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Orthopaedic surgeons performing conventional and robot-assisted TKA

Exclusion criteria

  • /

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

United Kingdom · 1 center
  • Circle health group - BMI The Park hospital — Nottingham

Identifiers

NCT: NCT06563843 · VRAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗