VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
ConditionTotal Knee Arthroplasty (TKA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorDEO NV
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Orthopaedic surgeons performing conventional and robot-assisted TKA
Disqualifiers
/
Trial 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.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Robotic-assisted TKA
Procedure/SurgeryRobotic-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.
Conventional TKA
Procedure/SurgeryConventional 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.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Performing VELYS robot-assisted TKA1 intervention
Group B: Performing conventional TKA1 intervention
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
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.
Time frame
3 months2
Ergonomic impaction - posture assessment
Surgeon's posture assessment using RULA and REBA method will be executed to report ergonomic impaction for the VRAS TKR compared to conventional TKR.
Time frame
3 months3
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.
Time frame
3 months Source ClinicalTrials.gov