Knee ArthropathyNCT03495232
Persona Cohort Nordic Multicenter Study
An observational study of Knee Arthropathy, run by Zimmer Biomet at 4 sites in 4 countries.
Trial summary
In this project the investigators wish to: Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system. This project is carried out as prospective cohort study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Zimmer Biomet Persona total knee system
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Nov 2016to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient planned for primary total knee arthroplasty (TKA) on orthopedic surgeons' waiting list may be asked and selected for the study.
Who may be able to join
- Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
Who cannot join
- Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
- Patients that meet any contraindications listed in the Instruction for Use
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Multicenter Prospective Cohort Study on Persona Total Knee System
In this project the investigators wish to:
Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.
Read more
This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.
Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively.
After the 2 year follow-up visit the patients recruited in the Scandinavian sites will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively. Since France does not have a national registry, the French site will also perform 5 year follow-up visits.
Read the detailed description
The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations.
The enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed.
Surgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant.
Participants will receive standard pain treatment and rehabilitation until discharge.
- Conditions
- Knee Arthropathy
- Being tested
- Zimmer Biomet Persona total knee system
- Keywords
- Total Knee Arthroplasty, Persona knee system, osteoarthrosis, Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Biomet Persona total knee systemDevice
Product manufactured by Zimmer Biomet used to replace the knee joint.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system as measured by Oxford knee score (OKS); a 12-item patient-reported Patient Reported Outcomes specifically designed and developed to assess function and pain after total knee replacement surgery. Score ranging from 0 (most severe symptoms/problems) to 48 (least severe).
Measured: 2 years
Secondary outcomes (7)
Evaluate patient reported physical activity level following primary total knee replacement using Persona Total Knee system. An 8-item patient-reported outcome. Score ranging from 0 (most severe symptoms/problems) to 32 (least severe).
Oxford knee score Activity \& Participation Questionnaire (OKS, APQ)
Measured: 2 years
Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system
EuroQol Group (EQ5D) standardized measure of health status. Measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Overall health status rated by the patient using the visual analogue scale (EQ-VAS).
Measured: 2 years
Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system
Anchoring questions. Focusing on Patient perception of their knee and their satisfaction with the knee after their knee surgery
Measured: 2 years
Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system
Forgotten Joint Score (FJS)
Measured: 2 years
Evaluate intraoperative and postoperative complications
Register adverse events including intraoperative complications and revisions at any postoperative time point.
Measured: 10 years
Evaluate implant positioning following primary total knee replacement using Persona Total Knee system
Measure radiolucency and osteolysis using conventional radiographs in anterior posterior (AP) and lateral views.
Measured: 2 years
Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system
Survival of the implant through registries
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Nov 2016
- Primary completion7 Apr 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Troelsen, Prof, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495232
- Sponsor's protocol ID
- K.CR.I.EU.15.13 Cohort
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2018
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study on Persona Total Knee System
- ClinicalTrials.gov ID
- NCT03495232
- Acronym / sponsor ID
- K.CR.I.EU.15.13 Cohort
- Conditions
- Knee Arthropathy
- Keywords
- Total Knee Arthroplasty, Persona knee system, osteoarthrosis, Knee
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 7 Apr 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this project the investigators wish to:
Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.
This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.
Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively.
After the 2 year follow-up visit the patients recruited in the Scandinavian sites will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively. Since France does not have a national registry, the French site will also perform 5 year follow-up visits.
Detailed description
The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations.
The enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed.
Surgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant.
Participants will receive standard pain treatment and rehabilitation until discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient planned for primary total knee arthroplasty (TKA) on orthopedic surgeons' waiting list may be asked and selected for the study.
Key inclusion criteria (1 listed)
- Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
Key exclusion criteria (2 listed)
- Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
- Patients that meet any contraindications listed in the Instruction for Use
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 |
|---|---|---|
| Zimmer Biomet Persona total knee systemProduct manufactured by Zimmer Biomet used to replace the knee joint. | Device | – |
Primary outcome
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system
Time frame: 2 years
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system as measured by Oxford knee score (OKS); a 12-item patient-reported Patient Reported Outcomes specifically designed and developed to assess function and pain after total knee replacement surgery. Score ranging from 0 (most severe symptoms/problems) to 48 (least severe).
7 secondary outcomes
Evaluate patient reported physical activity level following primary total knee replacement using Persona Total Knee system. An 8-item patient-reported outcome. Score ranging from 0 (most severe symptoms/problems) to 32 (least severe).
Time frame: 2 years
Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system
Time frame: 2 years
Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system
Time frame: 2 years
Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system
Time frame: 2 years
Evaluate intraoperative and postoperative complications
Time frame: 10 years
Evaluate implant positioning following primary total knee replacement using Persona Total Knee system
Time frame: 2 years
Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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.
Anders Troelsen, Prof principal investigator
Copenhagen University Hospital, Hvidovre
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy, run by Zimmer Biomet at 4 sites in 4 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, France, Norway, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system (time frame: 2 years). 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 2 Oct 2026.