ROSA Robot Used in Total Knee Replacement Post Market Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System

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

Intervention / Treatment
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* Device: PERSONA Total Knee
* Device: Vanguard Total Knee
* Device: NexGen 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 Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard 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

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 | Device: PERSONA Total Knee<br>* Primary Total Knee Arthroplasty<br>Device: Vanguard Total Knee<br>* Primary Total Knee Arthroplasty<br>Device: NexGen 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>Device: Vanguard Total Knee<br>* Primary Total Knee Arthroplasty<br>Device: NexGen 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 |
| --- | --- | --- |
| 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. 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 and the maximum score is 48 points. | 1 year | 
| Workflow Efficiency | Intraoperative questionnaire detailing surgical and OR efficiencies. Operative Time Tourniquet Time Personnel involved/present in OR Knee Alignment Values | 1 year |