Knee PainNCT04338893
ROSA Total Knee Post Market Study EMEA
A study testing Device: Persona Total Knee, Device: NexGen Total Knee and Device: Vanguard Total Knee in people with Knee Pain and Chronic Osteoarthritis, run by Zimmer Biomet at 6 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle
- What is being tested?
- Device: Persona Total Knee, Device: NexGen Total Knee and Device: Vanguard Total Knee
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 15 Dec 2020to 22 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Germany2 sites
Herzogin Elisabeth Hospital
Braunschweig
Evangelisches Waldkrankenhaus Spandau
Spandau
About this study
Official title: 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.
Read the 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
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
- Being tested
- Device: Persona Total Knee, Device: NexGen Total Knee, Device: Vanguard Total Knee
- Medical subject headings
- Genu Valgum, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Persona Total KneeProcedure or surgery
The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
Device: NexGen Total KneeProcedure or surgery
The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
Device: Vanguard Total KneeProcedure or surgery
The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice
| Study group | Role | What they receive |
|---|---|---|
| ROSA Total Knee Robotic Instrumentation | Active comparator | Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation Receives: Procedure: Device: Persona Total Knee; Procedure: Device: NexGen Total Knee; Procedure: Device: Vanguard Total Knee |
| Conventional TKA Instrumentation | Active comparator | Total knee arthroplasty performed with conventional instrumentation Receives: Procedure: Device: Persona Total Knee; Procedure: Device: NexGen Total Knee; Procedure: Device: Vanguard Total Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative, 3 months
Secondary outcomes (10)
Operative Workflow Efficiency
Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Dec 2020
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee PainStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338893
- Sponsor's protocol ID
- CME2019-24K
- Status last verified
- Dec 2025
- First submitted
- 24 Jan 2020
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
- ClinicalTrials.gov ID
- NCT04338893
- Acronym / sponsor ID
- CME2019-24K
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROSA Total Knee Robotic Instrumentation | Active comparator | Procedure: Device: Persona Total Knee, Procedure: Device: NexGen Total Knee, Procedure: Device: Vanguard Total KneeTotal knee arthroplasty performed with ROSA Total Knee Robotic instrumentation |
| Conventional TKA Instrumentation | Active comparator | Procedure: Device: Persona Total Knee, Procedure: Device: NexGen Total Knee, Procedure: Device: Vanguard Total KneeTotal knee arthroplasty performed with conventional instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Persona Total KneeThe choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice | Procedure or surgery | Conventional TKA Instrumentation, ROSA Total Knee Robotic Instrumentation |
| Device: NexGen Total KneeThe choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice | Procedure or surgery | Conventional TKA Instrumentation, ROSA Total Knee Robotic Instrumentation |
| Device: Vanguard Total KneeThe choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice | Procedure or surgery | Conventional TKA Instrumentation, ROSA Total Knee Robotic Instrumentation |
Primary outcome
Alignment Accuracy
Time frame: Pre-operative, 3 months
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.
10 secondary outcomes
Operative Workflow Efficiency
Time frame: Intraoperative
Oxford Knee Score (OKS)
Time frame: Pre-operative, 6 weeks, 3 months, 1 year
EuroQol 5D (EQ-5D) - Score
Time frame: Pre-operative, 6 weeks, 3 months, 1 year
EuroQol 5D (EQ-5D) VAS Scale
Time frame: Pre-operative, 6 weeks, 3 months, 1 year
NRS (Numeric Rating Scale) Pain
Time frame: Pre-operative, 6 weeks, 3 months, 1 year
Forgotten Joint Score (FJS)
Time frame: Pre-operative, 6 weeks, 3 months, 1 year
Patient Satisfaction - Question 1
Time frame: 6 weeks, 3 months, 1 year
Patient Satisfaction - Question 2
Time frame: 6 weeks, 3 months, 1 year
Patient Satisfaction - Question 3
Time frame: 6 weeks, 3 months, 1 year
Patient Satisfaction - Question 4
Time frame: 6 weeks, 3 months, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Rohmer study director
Zimmer Biomet
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Persona Total Knee, Device: NexGen Total Knee and Device: Vanguard Total Knee in people with Knee Pain and Chronic Osteoarthritis, run by Zimmer Biomet at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, Israel, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alignment Accuracy (time frame: Pre-operative, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.