Severe Knee PainNCT02337244
Zimmer POLAR Persona - TKA (EMEA Study)
An observational study of Severe Knee Pain and Severe Knee Disability, run by Zimmer, GmbH at 12 sites in 6 countries.
Trial summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include: 1. Implant survivorship based on removal of a study device. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Knee Pain, Severe Knee Disability, Osteoarthritis
- What is being tested?
- Zimmer Persona Total Knee System
- Type of treatment
- Medical device
- How many people
- 777 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 18 Nov 2013to Dec 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System.
Who may be able to join
- Patient 18-75 years of age, inclusive.
- Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
- collagen disorders and/or avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus, or flexion deformities;
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- the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations.
- Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling.
Who cannot join
- Patient is currently participating in any other surgical intervention studies or pain management studies.
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
- Insufficient bone stock on femoral or tibial surfaces.
- Skeletal immaturity.
- Neuropathic arthropathy.
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
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- Stable, painless arthrodesis in a satisfactory functional position.
- Severe instability secondary to the absence of collateral ligament integrity.
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
- 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
12 sites in 6 countries.
12 sites in 6 countries
United Kingdom4 sites
Golden Jubilee National Hospital
Clydebank
Harrogate and District NHS
Harrogate, HG2 7SX
University of Leeds
Leeds, Leeds/UK, LS2 9JT
The Newcastle Upon Tyne Hospitals
Newcastle
France2 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Centre Hospitalier régional Universitaire de Montpellier
Montpellier, 34980
Netherlands1 site
Stichting Research Orthopedie & Reinier de Graaf Groep
Delft, 2612
About this study
Official title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:
- Implant survivorship based on removal of a study device.
- Safety based on incidence and frequency of adverse events.
- Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
Read the detailed description
This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis
- Being tested
- Zimmer Persona Total Knee System
- Keywords
- Osteoarthritis, Rheumatoid arthritis, Traumatic arthritis, Polyarthritis, Total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Persona Total Knee SystemDevice
Also called Primary Knee Replacement, Total Knee Arthroplasty, Total Knee Replacement
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier Implant Survivorship
Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.
Measured: 5 years
Secondary outcomes (4)
'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.
The scores related to the five KOOS subscales calculated at different time points until 5 years.
Measured: 5 years
'Forgotten Joint Score' (FJS-12)
The score related to the FJS-12 patient-reported questionaire calculated at different time points until 5 years.
Measured: 5 years
Oxford Knee Score (OKS)
The score related to the OKS patient-reported questionaire calculated at different time points until 5 years.
Measured: 5 years
EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)
The scores related to the EQ-5D-3L questionnaire and the EQ-VAS calculated at different time points until 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start18 Nov 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Knee PainStudies of the same condition, open and under way.
- 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
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer, GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Dominkus, MD, Principal investigator, Orthopädisches Spital Speising, Wien, AustriaHendrik Verburg, MD, Principal investigator, Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, NetherlandsNicholas London, MD, Principal investigator, Harrogate and District NHS, Harrogate, EnglandStéphane Boisgard, MD, Principal investigator, CHU de Clermont-Ferrand, Clermont-Ferrand, FranceFrançois Canovas, Prof, Principal investigator, Hospital Lapeyronie, MontpellierPere Torner, MD, Principal investigator, Hospital Parc Tauli, SabadellJon Clarke, MD, Principal investigator, Golden Jubilee National Hospital, ClydebankDavid Deehan, Prof, Principal investigator, Freeman Hospital, Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337244
- Sponsor's protocol ID
- CSE2013-07K
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2015
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.
PubMed 30832636
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)
- ClinicalTrials.gov ID
- NCT02337244
- Acronym / sponsor ID
- CSE2013-07K
- Conditions
- Severe Knee Pain, Severe Knee Disability, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis
- Keywords
- Osteoarthritis, Rheumatoid arthritis, Traumatic arthritis, Polyarthritis, Total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 777 participants (actual)
- Lead sponsor
- Zimmer, GmbHIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- 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.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:
- Implant survivorship based on removal of a study device.
- Safety based on incidence and frequency of adverse events.
- Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
Detailed description
This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System.
Key inclusion criteria (9 listed)
- Patient 18-75 years of age, inclusive.
- Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations.
- Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling.
Key exclusion criteria (12 listed)
- Patient is currently participating in any other surgical intervention studies or pain management studies.
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
- Insufficient bone stock on femoral or tibial surfaces.
- Skeletal immaturity.
- Neuropathic arthropathy.
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 Persona Total Knee SystemAlso: Primary Knee Replacement, Total Knee Arthroplasty, Total Knee ReplacementNo Intervention | Device | – |
Primary outcome
Kaplan-Meier Implant Survivorship
Time frame: 5 years
Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.
4 secondary outcomes
'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.
Time frame: 5 years
'Forgotten Joint Score' (FJS-12)
Time frame: 5 years
Oxford Knee Score (OKS)
Time frame: 5 years
EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)
Time frame: 5 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 25 Nov 2025.
- Derived from this study: PubMed 30832636Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.
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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.
Martin Dominkus, MD principal investigator
Orthopädisches Spital Speising, Wien, Austria
Hendrik Verburg, MD principal investigator
Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands
Nicholas London, MD principal investigator
Harrogate and District NHS, Harrogate, England
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Knee Pain and Severe Knee Disability, run by Zimmer, GmbH at 12 sites in 6 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 9 inclusion and 12 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, France, Germany, Spain, Austria and 1 more country. 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?
Kaplan-Meier Implant Survivorship (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337244, which also lists 1 linked publication.
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 25 Nov 2025.