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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performing VELYS robot-assisted TKA | Surgeons performing VELYS robot-assisted TKA |
| |
| Performing conventional TKA | Surgeons performing conventional TKA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ergonomic impaction - weight of trays | Weight of trays will be measured to report ergonomic impaction of the team for the VRAS TKR compared to conventional TKR. | 3 months |
| Ergonomic impaction - posture assessment |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aline BR Vandeputte, Msc. | Contact | +32469154039 | aline@deo.care | |
| Jeroen Dille, Msc. | Contact | +32468290492 | jeroen@deo.care |
| Name | Affiliation | Role |
|---|---|---|
| Willem Franssen, Msc. | DEOcare | Study Director |
| Benjamin Bloch, M.D. | Circle Health Group - BMI The Park Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Circle health group - BMI The Park hospital | Recruiting | Nottingham | NG5 8RX | United Kingdom |
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| 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. |
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Surgeon's posture assessment using RULA and REBA method will be executed to report ergonomic impaction for the VRAS TKR compared to conventional TKR.
| 3 months |
| Total procedure cost | 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. | 3 months |