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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Subjects will be implanted with an ATTUNE Primary total knee replacement.
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Cuyuna Regional Medical Center
Crosby, Minnesota, United States
OrthoCarolina
Charlotte, North Carolina, United States
Campbell Clinic
Germantown, Tennessee, United States
Proliance Orthopedic Associates
Renton, Washington, United States
Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks.
The primary objective of this clinical investigation is to evaluate whether the accuracy to plan of the long leg alignment achieved with 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 by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome.
Time frame: 12 weeks
Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks.
The accuracy of the distal femoral varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
Time frame: 12 weeks
Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks
The accuracy of the proximal tibial varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
Time frame: 12 weeks
Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks
The accuracy of the femoral component flexion angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
Time frame: 12 weeks
Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks
The accuracy of the Tibial slope angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
Time frame: 12 weeks
Type and Frequency of Adverse Events
Rate of local Adverse events and local serious adverse events reported within the first 90 days and the first year post surgery. Local means at the site of the procedure (i.e. the operated Knee). Serious adverse events are events that required medical or surgical intervention to prevent a serious impairment to health.
Time frame: 12 weeks, 1 year
Soft Tissue Damage
Investigators conducted an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts.
Time frame: Day of operation (intraoperative)
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