Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.

Official Title
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Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center Post-market Clinical Investigation

Conditions
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Osteo Arthritis Knee, Osteoarthritis

Intervention / Treatment
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* Device: Total Knee Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive. Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable candidate for primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor Subject is currently not permanently bedridden, as determined by the Investigator Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English. Subject's pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery. Exclusion Criteria: The Subject is a woman who is pregnant or lactating. Contralateral knee has already been enrolled in this study. Subject had a contralateral amputation. Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. Subject has an active local or systemic infection Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy) Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Arm<br>Subjects enrolled into this arm of the study will receive an ATTUNE primary total knee replacement that has been implanted using manual instrumentation which is the current standard of care at the participating sites. | Device: Total Knee Replacement<br>* Subjects will be implanted with an ATTUNE Primary total knee replacement.<br>|
| Experimental: Robotic-Assisted Arm<br>Subjects enrolled into this arm will receive an ATTUNE primary total knee replacement that has been implanted with the use of the VELYS Robotic-Assisted Solution device. | Device: Total Knee Replacement<br>* Subjects will be implanted with an ATTUNE Primary total knee replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Long leg Alignment | To determine whether the accuracy to plan of the long leg alignment achieved with the VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed on long-leg X-rays taken at 12 weeks. If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of mechanical axis alignment achieved with VELYS Robotic-Assisted Solution will be conducted. | 12 weeks post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and frequency of adverse events | Evaluate the nature, severity, and frequency of local adverse events associated with the use of the VELYS Robotic-Assisted Solution in total knee arthroplasty during the procedure and within the subsequent 12 weeks, 90 days and 1 year. | Day of operation (intraoperative), 12 weeks, 1 year | 
| Soft tissue damage | Investigators will conduct an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts. | Day of operation (intraoperative) | 
| Alignment Outliers | The alignment outliers (>3 degrees outside of plan) in both Manual and Robotics cohorts will be summarized | 12 weeks | 
| Surgical time | The surgical time (skin to skin), Operative time (wheels in wheels out) and total operative room utilization time will be summarized for both manual and robotic-assisted cohorts. | Day of operation (intraoperative) | 
| Accuracy of position of components | Individual component alignment achieved with manual instruments and Robotic-assisted in the frontal and sagittal planes will be summarized, specifically: distal femoral varus-valgus (FM), proximal tibial varus-valgus (TM), femoral component flexion and tibial slope. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Knee, Robotic-Assisted, VELYS, Accuracy