This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
181
Primary Total Knee Arthroplasty
Primary Total Knee Arthroplasty
Primary Total Knee Arthroplasty
Vail-Summit Orthopaedics
Vail, Colorado, United States
Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
Westminster, Colorado, United States
SIU School of Medicine
Springfield, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
OrthoVirginia Chippenham
North Chesterfield, Virginia, United States
Clinical Performance
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Post-Operative Pain & Satisfaction
Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Time frame: 6 weeks, 3 months, and 1 year
Total Range of Motion
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
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