This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed. The primary objectives will be assessed by measuring: 1. Intra-operative complications 2. Verification that the device performs as intended 3. Overall surgeon satisfaction with the instrumentation.
This study will involve single-arm, monocentric, cross-sectional observations conducted on the day of surgery. All assessments will take place during the pre-operative, intra-operative, and immediate postop periods on the day of surgery, with no additional follow-up beyond the procedure as robotic-assisted surgery using the current version of the robot is part of routine practice. The safety of the system is the primary endpoint. This will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary endpoint is defined by the usability of Zimmer Biomet ROSA® Knee System, v1.5. It will be assessed by: 1. Robotic log files to assess differences in the proposed plans by the system's new features and plan approved by the surgeon, along with time spent in the planning panel. 2. Surgeon satisfaction with the new features.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
Robotic-assisted primary total knee arthroplasty, evaluating updated features for the Zimmer Biomet ROSA® Knee System, v1.5.
Kensington Private Hospital
Kensington, Whangarei, New Zealand
Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. This will occur through the reporting of adverse events that outline the details and relationship to: 1. Device 2. Procedure 3. Instruments 4. Cement in order to determine device-related or non-device-related complications that occur during the procedure. Thus the incidence of procedure-emergent adverse events will notify and quantify the safety of the features added to the subject device (ROSA® Knee System v1.5 System)
Time frame: Intra-operative observations, with immediate post-operative documentation and reporting period.
Verification and Usability of the OptimiZe Planning and Activ Track Investigational Features of the ROSA® Knee System v1.5 System
Robotic log files will be evaluated to assess the following: a) The delta between the OptimiZe proposed plan and the final plan approved by the surgeon, planned and final laxities, planned and final resections thus allowing for conclusions to be drawn from objective datapoints on the verification of the OptimiZe planning feature, and its validation to execute the proposed plan. Additionally, surgeon satisfaction with the features will be evaluated with the following questionnaire (Case Report Form), to determine usability: 1. Were you able to perform tracker calibration? 2. Were you able to complete painting? 3. Were you able to perform the contact point step? 4. Overall, how satisfied are you with the usability of OptimiZe to assist with planning? 5. Overall, how satisfied are you with the usability of Activ Track to complete the resections? 6. How likely are you to recommend The ROSA Knee System v1.5 application to a peer? Q1-4 are yes/no, Q5-6 are subjective scales with 5 answers.
Time frame: Intra-operative evaluation, with immediate post-operative assessment and documentation. Data and statistical analysis will take place after the recruitment period has concluded.
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