ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
Phase: NA
Conditions: Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Sponsor: Zimmer Biomet

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ROSA Total Knee Post Market Study 
 
A prospective, multicenter, EMEA post market clinical follow up 
of the ROSA® Knee System 
 
CME2019-24K 
 
V3.0, 4 February 2020 
 
 
 
STUDY SPONSOR 
Zimmer GmbH Clinical Affairs  
Sulzerallee 8 
P.O. Box CH-8404 Winterthur  
Switzerland 
 
 
 
 
 

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Study Synopsis 
Title 
ROSA Total Knee Post Market Study – a prospective, multi-center 
EMEA post market clinical follow up study for the ROSA Total knee 
system 
Protocol Number 
CME2019-24K 
Sponsor 
Zimmer GmbH 
Manufacturer 
Zimmer CAS, 75 Queen Street Suite 33000, Montreal, Quebec. 
Canada 
Study Device(s) 
ROSA® Knee System 
Study 
Objectives/Endpoints 
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: 
1. 
Planned vs actual component positioning 
2. 
Operative workflow efficiency 
3. 
Patient safety based on incidence and frequency of adverse 
events 
4. 
Clinical performance measured by overall pain and function, 
health- related quality of life data, and radiographic 
parameters. 
 
Primary endpoint: 
Evaluate the accuracy of implant alignment for ROSA total knee 
robotic instrumentation compared to conventional instrumentation, 
by measuring femoral rotation in the axial plane using pre op and 
post op CT assessments. 
 
Secondary endpoints: 
Measure operative workflow efficiency by recording following time 
points during surgery: 
Patient in –and out time, incision – and incision closed time 
 
Evaluate the change of the following scores between baseline and 
each post-operative follow up for performance and clinical benefits: 
• Oxford Knee Score 
• Objective Knee Assessment 
• Patient Satisfaction 
• EQ-5D 
• NRS Pain 
• FJS-12 
Indications/Target 
population 
Patients qualifying for primary total knee arthroplasty who meet the 
inclusion/exclusion criteria for study participation 

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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 
Study Design 
Prospective, multicenter study, using Zimmer Biomet commercially 
available Persona, NexGen and Vanguard total knee implant system. 
Each consecutive, potential and eligible patient presenting as a 
candidate for primary knee arthroplasty will be offered study 
participation. 
 
Selection process should be rotated on an equal basis. (eg. 5 
Robotic TKA’s followed by 5 Conventional TKA’s and so on until 
enrolment is complete) 
Clinical Phase 
Post market 
Sample Size 
Maximum 8 EMEA sites, with participating surgeons contributing 
from 20 of each robotic and conventional knees per site. 
Maximum study enrolment of 240 subjects in total, including 40 
subjects in the CT sub cohort 
Length of Study 
2,5 years (1,5 year enrolment with 1 year of follow-up). Follow-up 
visits at 6 weeks, 3 months and 1 year. 

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Materials and 
Methods 
Inclusion of 240 eligible subjects within maximum of 8 EMEA sites, 
divided into 2 groups (robotic and conventional group). 
 
Sub cohort of 40 subject for CT assessment and analysis 
 
Prospective follow up visit until 1 year post-operative with clinical 
and radiographic assessments. 
Data Collection 
Web based database (Electronic data capture system) 
Statistical Reporting 
Performance will be evaluated for pain, function, health- related 
quality of life, and planned component position vs post-op 
component position. Data will be summarized descriptively additional 
to evaluation of data on surgical technique and instrumentation. 
Categorical data (e.g., gender or race) will be summarized using 
counts and percentages with 95% Confidence Interval (CI) limit over 
the time period of interest. Continuous data, such as age, will be 
summarized by using means, medians, SD, minimum, maximum, 
and 95% CI over the time period of interest. Implant survival and 
return to function will be summarized using a Kaplan-Meier method 
and presented with rates (as percentages) and CI. 
 
Routine summaries of complication data is represented by 
frequencies and percentages. The sample size is based on a 
longitudinal data collection model and using functional outcomes as 
secondary endpoints. 
 
The data from the CT sub cohort will detect for a difference in 
deviation from the initial alignment target proportions and presented 
with rates (as percentages) and CI. 
Continuous data from pre and post-operative CT measurement will 
be summarized by using means, medians, SD, minimum, maximum 
and 95% CI over the time period of interest. 
Scores/Performance 
Assessments 
Clinical performances are assessed by the following scores: 
• Oxford Knee Score 
• Objective Knee Assessment 
• Patient Satisfaction 
• EQ-5D 
• NRS Pain 
• FJS-12 
 
Radiographic performances are assessed by: 
• Radiographic imaging method pre- and post-operatively 
• Sub cohort for CT scan pre- and post-operatively 
Standards 
The PMCF is compliant with the below: 
• The Declaration of Helsinki (DoH) - Ethical principles for 
medical research involving human subjects. [1] 
• ISO 14155: 2011 - Clinical investigation of medical devices for 
human subjects - Good clinical practice. [2] 

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References 
[1] WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI, Ethical Principles 
for Medical Research Involving Human Subjects, Version October 2013. 
[2] ISO 14155:2011 International Standard for Clinical investigation of medical devices 
for human subjects -- Good clinical practice. 

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