ROSA Total Knee Post Market Study EMEA

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 surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.

Detailed Description
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The main purpose of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation. This will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters. The primary endpoint will report on the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits

Official Title
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ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System

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

Intervention / Treatment
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* Procedure: Device: Persona Total Knee
* Procedure: Device: NexGen Total Knee
* Procedure: Device: Vanguard Total Knee


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion criteria Inclusion criteria: Patient is a minimum of 18 years of age Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or 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 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 contractures, 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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No

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: ROSA Total Knee Robotic Instrumentation<br>Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation | Procedure: Device: Persona Total Knee<br>* The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice<br>Procedure: Device: NexGen Total Knee<br>* The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice<br>Procedure: Device: Vanguard Total Knee<br>* The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice<br>|
| Active Comparator: Conventional TKA Instrumentation<br>Total knee arthroplasty performed with conventional instrumentation | Procedure: Device: Persona Total Knee<br>* The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice<br>Procedure: Device: NexGen Total Knee<br>* The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice<br>Procedure: Device: Vanguard Total Knee<br>* The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation | measuring femoral rotation in the axial plane using pre and post op CT assessments | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure operative workflow efficiency by recording following time points during surgery | time points recorded are: patient in-and out time, incision- and incision closed time | 1 year | 
| Evaluate the change of the Oxford Knee Score between baseline and each post-operative follow up | Oxford Knee Score is a patient-reported form and consists of 12 questions on the influence of the knee (surgical side) on daily activities or pain. The patient scores each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome). | 1 year | 
| Evaluate Health related quality of life at baseline and each post-operative follow up | EQ-5D-5L health questionnaireEuroqol-5 dimensions by the EuroQol Group consists of a descriptive system of health-related quality of life by a questionnaire and a thermometer scale. The Questionnaire comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with each 5 levels: no problems (level 1), slight problems (level 2), moderate problems, (level 3) severe problems (level 4) and extreme problems (level 5). The digits for the five dimensions can be combined into a 5-digit number and may be converted to a score (maximum is 1), defined by the health state classification.The Thermometer generates a self rating of current health-related quality of life and has end points of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. It should be used with the 5-digit health state classification to build a composite picture of the respondent's health status. | 1 year | 
| Evaluate Pain intensity at baseline and each post-operative follow up | NRS Pain (Numeric Rating Scale for Pain). NRS Pain is a numeric scale from 0 to 10 to measure pain intensity from 0 (no pain) to 10 (worst imaginable pain) | 1 year | 
| Evaluate knee functionality at baseline and each post-operative follow up | Objective Knee Assessment is used to assess knee functionality by the investigator with objective knee indicators (2011 The Knee Society) up to 100 points. A higher score means a better functional outcome | 1 year | 
| Evaluate awareness of patients affected knee joint at baseline and each post operative follow up | FJS-12 is a patient-reported form and consist of 12 questions to assess awareness of patients affected knee joint in daily activities.all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 top 100. A high score indicate a high degree of forgetting the artificial joint, i.e. a lower degree of awareness. | 1 year | 
| Evaluate patient satisfaction at baseline (first postop visit) and each post operative follow up | Patients to provide additional information regarding the level of satisfaction with the operated knee by answering 4 questions with 4 options to answer from very satisfied, satisfied, dissatisfied to very dissatisfied | 1 year |