Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563843
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
VRAS Velys Robot-Assisted Solution Operational Excellence Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Velys Robotic-Assisted Solution VRAS and Conventional Surgery in Total Knee Arthroplasty An Operational Excellence Evaluation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None