ROSA Total Knee Investigational Testing Authorization Study

Study Overview
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Brief Summary
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This is a prospective, single-center 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 Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.

Detailed Description
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The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty. The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Official Title
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ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System

Conditions
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Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis

Intervention / Treatment
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* Device: PERSONA Total Knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a minimum of 18 years of age Pre-op component positioning and sizing plan prior to surgery Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona knee components implanted in accordance with product labeling Patient has participated in this study-related Informed Consent process Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form Patient is willing and able to complete scheduled study procedures and follow-up evaluations Exclusion Criteria: Patient is currently participating in any other surgical intervention studies or pain management studies Patient has underwent contralateral UKA or TKA within the last 18 months Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation) Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic Assisted TKA<br>Robotic Assisted TKA via ROSA Robot | Device: PERSONA Total Knee<br>* Primary Total Knee Arthroplasty<br>|
| Active Comparator: Conventional TKA<br>Conventional TKA | Device: PERSONA Total Knee<br>* Primary Total Knee Arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D questionnaire | EQ-5D | 1 year | 
| Oxford Knee Score Questionnaire | Oxford Knee Score | 1 year |