Total Knee Arthroplasty (TKA)
Conditions
Keywords
VELYS, Total Knee Arthroplasty (TKA), Process flow, Robotic-assisted surgery, Operational excellence
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.
Interventions
PROCEDURERobotic-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.
PROCEDUREConventional 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.
Sponsors
DEO NV
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Orthopaedic surgeons performing conventional and robot-assisted TKA
Exclusion criteria
* /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operational efficiency | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ergonomic impaction - weight of trays | 3 months | Weight of trays will be measured to report ergonomic impaction of the team for the VRAS TKR compared to conventional TKR. |
| Ergonomic impaction - posture assessment | 3 months | Surgeon's posture assessment using RULA and REBA method will be executed to report ergonomic impaction for the VRAS TKR compared to conventional TKR. |
| Total procedure cost | 3 months | The procedure cost differences between VRAS TKR and conventional TKR will be calculated using activity based costing modeling. This model will include fixed direct, fixed indirect, and variable costs, tailored to each country's local cost parameters and healthcare financing models. |
Countries
United Kingdom
Contacts
Primary ContactAline BR Vandeputte, Msc.
Backup ContactJeroen Dille, Msc.
Outcome results
None listed