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UNKNOWNN/A

VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

Sponsor: DEO NV

NCT ID: NCT06563843

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Robotic-assisted TKA (procedure), Conventional TKA (procedure)
How long the study runs
Study runs about 23 months (dates as stated)
About the drug or intervention
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. · 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.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 100 Years
Who
All
Number of participants
10
Started
2024-08-27
Last checked
2024-08

Plain English Summary

What is this study?

  • • Testing a new treatment for total knee arthroplasty (tka)
  • • Clinical study - 10 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with total knee arthroplasty (tka)

Where?

  • • Nottingham - Circle health group - BMI The Park hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Total Knee Arthroplasty (TKA)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 100 Years
  • Who can join: All genders

What the study is looking for

  • ✓Orthopaedic surgeons performing conventional and robot-assisted TKA
See the full criteria
Inclusion Criteria: * Orthopaedic surgeons performing conventional and robot-assisted TKA Exclusion Criteria: * /

Where Is This Study? (1 UK site)

Circle health group - BMI The Park hospital

Nottingham, United Kingdom

Recruiting

How to Get in Touch

Aline BR Vandeputte, Msc.

Sponsor contact

CONTACT

+32469154039 aline@deo.care

Jeroen Dille, Msc.

Sponsor contact

CONTACT

+32468290492 jeroen@deo.care
Data sourced from ClinicalTrials.gov · Last verified: 2024-08