VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

NCT06563843 | Recruiting

• 1 other identifier: VRAS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty (TKA)

Keywords

VELYS; Total Knee Arthroplasty (TKA); Process flow; Robotic-assisted surgery; Operational excellence

Outcome Measures

Primary Outcomes (1)

• Operational efficiency

  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 Outcomes (3)

• Ergonomic impaction - weight of trays

  3 months

• Ergonomic impaction - posture assessment

  3 months

• Total procedure cost

  3 months

Study Arms (2)

Performing VELYS robot-assisted TKA

Surgeons performing VELYS robot-assisted TKA

Procedure: Robotic-assisted TKA

Performing conventional TKA

Surgeons performing conventional TKA

Procedure: Conventional TKA

Interventions

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.

Also known as: DePuy Synthes, Velys Robotic-Assisted Solution

Performing VELYS robot-assisted TKA

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.

Also known as: DePuy Synthes, Attune Knee System, Sigma Total Knee System

Performing conventional TKA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Orthopaedic surgeons performing conventional and robot-assisted TKA

Sponsors & Collaborators

• DEO NV: lead

Study Sites (1)

Circle health group - BMI The Park hospital

Nottingham, NG5 8RX, United Kingdom

RECRUITING

Study Officials

• Willem Franssen, Msc.

  DEOcare

  STUDY DIRECTOR

• Benjamin Bloch, M.D.

  Circle Health Group - BMI The Park Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline BR Vandeputte, Msc.

CONTACT

+32469154039; aline@deo.care

Jeroen Dille, Msc.

CONTACT

+32468290492; jeroen@deo.care

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 21, 2024
• Study Start: August 27, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)