Severe Knee PainNCT07843966
Persona Revision Knee System EMEA PMCF Study
An observational study of Severe Knee Pain and Severe Knee Disability, run by Zimmer, GmbH at 2 sites in 2 countries.
Trial summary
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- How many people
- 238 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2026to Dec 2038
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing revision total knee arthroplasty with the Persona Revision Knee System who meet the study eligibility criteria at participating study sites.
Who may be able to join
- Patient qualifies for a revision knee arthroplasty with the Persona Revision Knee System. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
- Patient experiences severe knee pain and disability due to:
- The salvage of previously failed knee surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- One-stage revision performed for infection OR
- Second stage (reimplantation) of a planned two-stage revision.
- Patient is ≥ 18 years.
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- Patient is skeletally mature.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Protocol and Informed Consent Form.
- Patient has participated in the Informed Consent process and is willing and able to sign the Informed Consent Form.
Who cannot join
- Patient received the study device for any condition not listed in the indications or in combination with a non-compatible device.
- First Knee Replacement patients.
- Patient with only inlay/bearing exchange/revision.
- Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
- Patient has any of the following contraindications:
- Any active or suspected latent infection in or about the knee joint or distant foci of infection which may cause hematogenous spread to the implant site: In any case, the infection needs to be treated prior to the revision surgery.
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- Insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
- Skeletal immaturity.
- Neuropathic arthropathy.
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity.
- Diagnosis of rheumatoid arthritis in conjunction with any of the following at the preoperative appointment: An ulcer of the skin, history of recurrent breakdown of the skin, use of steroids.
- Patients in whom the Persona Revision Knee System is used as a temporary, interim, spacer-type, or destination-spacer construct are not eligible, including use in a 1.5-stage revision strategy or as the first-stage construct in a planned 2-stage revision. Enrollment is restricted to subjects in whom the Persona Revision Knee System is implanted as the surgeon-intended definitive revision knee arthroplasty following infection eradication.
- Patient underwent contralateral total knee arthroplasty within 3 months of the planned index procedure or has a contralateral total knee arthroplasty planned within 3 months of the index procedure.
- Patient is known to be pregnant or planning to become pregnant during the time they will be participating in the study.
- Patient is a member of a vulnerable population group, such as
- A prisoner.
- A known alcohol or drug abuser.
- Mentally incompetent or unable to understand what participation in this study entails.
- Patient with suspected or confirmed metal sensitivity or allergy to the metals of the device.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: Post-Market Clinical Follow-Up Study to Provide Long-term Safety, Performance and Clinical Benefits Data of the Persona® Revision Knee System (Implants and Instrumentation)
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
Read the detailed description
Study Design:
This is a multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, Dual cohort study.
Objectives:
- Confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and its Instrumentation when used in revision TKA.
- Confirm that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording Patient-Reported clinical Outcome Measures (PROMs) and radiographic outcomes (if standard of care).
Condition Being Treated/Target population:
The target population for this study consists of patients presenting with a clinically diagnosed necessity for revision total knee arthroplasty with severe knee pain or reduction in functionality resulting in the need for salvage of previously failed surgical attempts, or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery
Per indication approved in the European Union and European Economic Area, only revision cases can be included in this study. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
EC Approval:
The study will require each site to obtain Ethics Committee approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
Length of Study:
12 years including at least 2 years of enrollment and 10 years of follow up.
Subjects must meet all the inclusion criteria and none of the exclusion criteria and receive the study device to participate in this study.
Study subjects will undergo preoperative clinical evaluations prior to their revision knee arthroplasty. The post-operative clinical and radiographic (if standard of care) evaluations will be conducted at 3 months, 1-year, 2-years, 3 -years, 5-years, 7-years and 10-years after implantation.
Data collection will de done in paper and electronic Case Report Forms (CRFs). CRFs will be completed either in-office or hospital at pre-operative, Surgery, Discharge, and the 3 months, 1-year, 2-year, and 5-year intervals. CRFs will be completed either in-office, by phone or by mail at the 3-year, 7-year, and 10-year intervals.
The PMCF is compliant with the following:
- ISO 14155: 2020 - Clinical investigation of medical devices for human subjects - Good clinical practice
- The Declaration of Helsinki (DoH) - Ethical principles for medical research involving human subjects
- European Regulation (EU) 2017/745
- MDCG 2020-10/1 Safety reporting in clinical investigations for medical devices under the Regulation (EU) 2017/745
Funding: Funding for this clinical study is made available by Zimmer Biomet to support clinical data collection, Ethic Committees review fees and other expenses associated with the conduct and execution of this study protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Persona Revision Knee + CCK articular surface | From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and the CCK articular surface. | |
| Cohort 2: Persona Revision Knee + CPS or PS articular surface | From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and CPS or PS articular surface. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxford Knee Score (OKS) from Baseline to 2 Years
Average change in Oxford Knee Score (OKS) from baseline to 2 years follow-up. The average change will be evaluated against the Minimal Clinically Important Difference (MCID) of 4.0 points.
Measured: From baseline (pre-operative assessment) to 2 years after surgery
Secondary outcomes (6)
All-Cause Implant Survival
All-cause survival of the implant system based on removal of any core system component (femoral component, tibial plate, or articular surface) for any reason
Measured: From surgery up to 10 years post-surgery
Adverse events / Safety
Safety of the Persona Revision Knee System assessed by the frequency and incidence of adverse events, including the relationship of events to the implant, instrumentation, and/or surgical procedure.
Measured: From surgery up to 10 years of follow-up
Oxford Knee Score - follow-up beyond the primary endpoint
Oxford Knee Score to assess knee pain and functional performance during follow-up. The Oxford Knee Score ranges from 0 to 48, with higher scores indicating better outcomes.
Measured: Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery
EQ-5D-5L Health Related Quality of Life
EQ-5D-5L to assess subject health-related quality of life during follow-up.Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale, from level 1 (no problems) to level 5 (extreme problems or inability), with higher levels indicating worse health status. The EQ visual analogue scale (EQ VAS) ranges from 0 to 100, with higher scores indicating better self-rated health.
Measured: Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery
Patient Satisfaction with the Study Knee and Treatment
Patient Satisfaction Questionnaire to assess patient satisfaction with the study knee and treatment. Patient satisfaction with the study knee and treatment will be assessed using the Patient Satisfaction Questionnaire. The questionnaire includes three questions: usual knee pain during the past 4 weeks, satisfaction with the knee replacement, and willingness to undergo the surgery again. Responses are categorical and will be summarized descriptively; no total questionnaire score will be calculated. Knee pain is rated as None, Very mild, Mild, Moderate, or Severe, with higher severity indicating worse outcome. Satisfaction is rated as Very satisfied, Satisfied, Neutral, Dissatisfied, or Very dissatisfied, with higher satisfaction indicating better outcome. Willingness to undergo surgery again is recorded as Yes or No.
Measured: 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery
Percentage (%) of Participants with significant radiographic findings
Presence or absence of significant radiographic findings will be assessed by standard-of-care radiographs. If a significant finding is identified, the type of finding is documented, including osteolysis, radiolucency, radiodensity, bone loss, subsidence, heterotopic ossification, fracture, implant loosening, articular surface wear, patellar dislocation, subluxation, tilt, or other significant findings. The amount of the finding may be recorded in millimeters (mm) or degrees, when applicable.
Measured: From baseline up to 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer, GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Troelsen, MD, PhD, Principal investigator, Hvidovre University Hospital, Copenhagen, DenmarkFernando Martinez Delgado, MD, PhD, Principal investigator, Hospital Universitario Miguel Servet, Zaragoza, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843966
- Sponsor's protocol ID
- CMG2023-28K
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of individual participant data (IPD) has not yet been made and will be determined at a later stage of the study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study to Provide Long-term Safety, Performance and Clinical Benefits Data of the Persona® Revision Knee System (Implants and Instrumentation)
- ClinicalTrials.gov ID
- NCT07843966
- Acronym / sponsor ID
- CMG2023-28K
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Zimmer, GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 28 Sep 2026 (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.
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
Detailed description
Study Design:
This is a multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, Dual cohort study.
Objectives:
- Confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and its Instrumentation when used in revision TKA.
- Confirm that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording Patient-Reported clinical Outcome Measures (PROMs) and radiographic outcomes (if standard of care).
Condition Being Treated/Target population:
The target population for this study consists of patients presenting with a clinically diagnosed necessity for revision total knee arthroplasty with severe knee pain or reduction in functionality resulting in the need for salvage of previously failed surgical attempts, or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery
Per indication approved in the European Union and European Economic Area, only revision cases can be included in this study. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
EC Approval:
The study will require each site to obtain Ethics Committee approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
Length of Study:
12 years including at least 2 years of enrollment and 10 years of follow up.
Subjects must meet all the inclusion criteria and none of the exclusion criteria and receive the study device to participate in this study.
Study subjects will undergo preoperative clinical evaluations prior to their revision knee arthroplasty. The post-operative clinical and radiographic (if standard of care) evaluations will be conducted at 3 months, 1-year, 2-years, 3 -years, 5-years, 7-years and 10-years after implantation.
Data collection will de done in paper and electronic Case Report Forms (CRFs). CRFs will be completed either in-office or hospital at pre-operative, Surgery, Discharge, and the 3 months, 1-year, 2-year, and 5-year intervals. CRFs will be completed either in-office, by phone or by mail at the 3-year, 7-year, and 10-year intervals.
The PMCF is compliant with the following:
- ISO 14155: 2020 - Clinical investigation of medical devices for human subjects - Good clinical practice
- The Declaration of Helsinki (DoH) - Ethical principles for medical research involving human subjects
- European Regulation (EU) 2017/745
- MDCG 2020-10/1 Safety reporting in clinical investigations for medical devices under the Regulation (EU) 2017/745
Funding: Funding for this clinical study is made available by Zimmer Biomet to support clinical data collection, Ethic Committees review fees and other expenses associated with the conduct and execution of this study protocol
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Persona Revision Knee + CCK articular surface | – | –From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and the CCK articular surface. |
| Cohort 2: Persona Revision Knee + CPS or PS articular surface | – | –From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and CPS or PS articular surface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing revision total knee arthroplasty with the Persona Revision Knee System who meet the study eligibility criteria at participating study sites.
Key inclusion criteria (9 listed)
- Patient qualifies for a revision knee arthroplasty with the Persona Revision Knee System. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
- Patient experiences severe knee pain and disability due to:
- The salvage of previously failed knee surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- One-stage revision performed for infection OR
- Second stage (reimplantation) of a planned two-stage revision.
Key exclusion criteria (21 listed)
- Patient received the study device for any condition not listed in the indications or in combination with a non-compatible device.
- First Knee Replacement patients.
- Patient with only inlay/bearing exchange/revision.
- Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
- Patient has any of the following contraindications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Oxford Knee Score (OKS) from Baseline to 2 Years
Time frame: From baseline (pre-operative assessment) to 2 years after surgery
Average change in Oxford Knee Score (OKS) from baseline to 2 years follow-up. The average change will be evaluated against the Minimal Clinically Important Difference (MCID) of 4.0 points.
6 secondary outcomes
All-Cause Implant Survival
Time frame: From surgery up to 10 years post-surgery
Adverse events / Safety
Time frame: From surgery up to 10 years of follow-up
Oxford Knee Score - follow-up beyond the primary endpoint
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery
EQ-5D-5L Health Related Quality of Life
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery
Patient Satisfaction with the Study Knee and Treatment
Time frame: 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery
Percentage (%) of Participants with significant radiographic findings
Time frame: From baseline up to 10 years after surgery
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 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data (IPD) has not yet been made and will be determined at a later stage of the study.
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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.
Anders Troelsen, MD, PhD principal investigator
Hvidovre University Hospital, Copenhagen, Denmark
Fernando Martinez Delgado, MD, PhD principal investigator
Hospital Universitario Miguel Servet, Zaragoza, Spain
2 sites in 2 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 2 sites in 2 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 21 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Spain. 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?
Contact Silvina Grasso, PhD (0034674348191, silvina.grasso@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxford Knee Score (OKS) from Baseline to 2 Years (time frame: From baseline (pre-operative assessment) to 2 years after surgery). 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 28 Sep 2026.