ROSA Total Knee Post Market Study EMEA

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of the Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities
• Intervention / Treatment: Procedure: Device: Persona Total Knee; Procedure: Device: NexGen Total Knee; Procedure: Device: Vanguard Total Knee

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Cliniques Universitaires Saint-luc
• Germany
  • Braunschweig, Germany
    • Herzogin Elisabeth Hospital
  • Spandau, Germany
    • Evangelisches Waldkrankenhaus Spandau
• Israel
  • Jerusalem, Israel
    • The Research Fund of Hadassah Medical Organization
• Italy
  • Arezzo, Italy
    • San Giuseppe Hospital
• Switzerland
  • Geneva, Switzerland
    • Hôpitaux Universitaires de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ROSA Total Knee Robotic Instrumentation; Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation	Procedure: Device: Persona Total Knee; The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice; Procedure: Device: NexGen Total Knee; The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice; Procedure: Device: Vanguard Total Knee; The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice
Active Comparator: Conventional TKA Instrumentation; Total knee arthroplasty performed with conventional instrumentation	Procedure: Device: Persona Total Knee; The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice; Procedure: Device: NexGen Total Knee; The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice; Procedure: Device: Vanguard Total Knee; The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alignment Accuracy	Evaluate the accuracy of implant component 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.	Pre-operative, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Workflow Efficiency	Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time	Intraoperative
Oxford Knee Score (OKS)	The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27	Pre-operative, 6 weeks, 3 months, 1 year
EuroQol 5D (EQ-5D) - Score	The EQ-5D is a standardized instrument widely used to measure health status, and it is a self-reported assessment about the patient's quality of life. The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-5L, each question can be answered in five ways, indicating no, slight, moderate, severe or extreme pain. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead.	Pre-operative, 6 weeks, 3 months, 1 year
EuroQol 5D (EQ-5D) VAS Scale	The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health.	Pre-operative, 6 weeks, 3 months, 1 year
NRS (Numeric Rating Scale) Pain	The NRS Pain is an outcome measure of pain intensity in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Scores range from 0-10 points, with 0 representing "no pain" to 10 representing "worst imaginable pain".	Pre-operative, 6 weeks, 3 months, 1 year
Forgotten Joint Score (FJS)	The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of having a joint prosthesis during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of awareness of having a joint prosthesis, while a total score of 0 indicates the highest level of awareness of having a joint prosthesis.	Pre-operative, 6 weeks, 3 months, 1 year
Patient Satisfaction - Question 1	Patients were asked to answer the following question: "How satisfied are you with the results of your surgery?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.	6 weeks, 3 months, 1 year
Patient Satisfaction - Question 2	Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your pain?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.	6 weeks, 3 months, 1 year
Patient Satisfaction - Question 3	Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your ability to do home or yard work?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.	6 weeks, 3 months, 1 year
Patient Satisfaction - Question 4	Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your ability to do recreational activities?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.	6 weeks, 3 months, 1 year

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Emilie Rohmer, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): August 22, 2025
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Genu Valgum
• Other Study ID Numbers: CME2019-24K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No