Clinical trial NCT06563843: VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
Official title: Comparison Between Velys Robotic-Assisted Solution (VRAS) and Conventional Surgery in Total Knee Arthroplasty: An Operational Excellence Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Knee Arthroplasty (TKA)
Keywords: VELYS
Total Knee Arthroplasty (TKA)
Process flow
Robotic-assisted surgery
Operational excellence
Lead sponsor: DEO NV
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Orthopaedic surgeons performing conventional and robot-assisted TKA

Exclusion Criteria:

* /

Primary outcomes:
measure: Operational efficiency
timeFrame: 3 months
Secondary outcomes:
measure: Ergonomic impaction - weight of trays
timeFrame: 3 months
measure: Ergonomic impaction - posture assessment
timeFrame: 3 months
measure: Total procedure cost
timeFrame: 3 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Circle health group - BMI The Park hospital
state: Ng5 8rx
Study officials:
affiliation: DEOcare
name: Willem Franssen, Msc.
role: STUDY_DIRECTOR
affiliation: Circle Health Group - BMI The Park Hospital
name: Benjamin Bloch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: