This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted UKA and that of traditional methods.
Sites will enroll participants into two separate arms for this study (rUKA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study and will be pre-screened for participation in the informed consent process. The primary objective of this study is to evaluate and compare the accuracy of the ROSA® Partial Knee System in regards to implant placement with that of traditional instrumentation. This will include the assessment of the planned vs. actual component positioning. Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures. Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12-18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Unicompartmental Knee Replacement
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States
Accuracy of implant position
To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Partial Knee System) with that of conventional instrumentation (Traditional UKA). Accuracy of the Implemented Plan will be evaluated by assessing Implant alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Partial Knee System.
Time frame: 6 Weeks
Evaluation of Patient safety
Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Time frame: 24 months
Evaluation of range of motion
Evaluation of knee flexion/extension pre-operatively and post-operatively
Time frame: 24 months
Evaluation of Instability
Medial/Lateral and Anterior/Posterior instability measured from none to severe(\>5mm).
Time frame: 24 months
Patient Reported Outcome Measure (Oxford Knee Score)
A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best).
Time frame: 24 months
Patient Reported Outcome Measure (KOOS-12)
A questionnaire completed by the patient consisting of a 12-item short form of the original 42-item Knee Injury Osteoarthritis Outcome Score (KOOS), and will be used to measure the patients' perception of pain, function, and knee-related quality of life
Time frame: 24 months
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Numeric Pain Rating Scale (NPRS)
An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip. On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable
Time frame: 24 Months
Subject Satisfaction
A questionnaire consisting of a single satisfaction question in regard to the subjects knee replacement. Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.
Time frame: 24 Months