Osteoarthritis, KneeNCT03073941
A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen
A study testing Persona total knee system and Nexgen total knee system in people with Osteoarthritis, Knee, run by Zimmer Biomet at 5 sites in Denmark.
Trial summary
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Persona total knee system and Nexgen total knee system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 5 sitesDenmark
- Study dates
- Dec 2016to 31 Dec 2031
- 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
- Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
- >18 years of age
- Participants must be able to speak and understand Danish
- Participants must be able to give informed consent and be cognitively intact
- Participants must be able to complete all post-operative controls
- Participants must not have severe comorbidities, American Society of Anesthesiologists (ASA) score ≤ 3
- Clinically suitable to receive a CR implant (no severe deformity and/or ligament instability)
Who cannot join
- Terminal illness
- Revision knee replacement surgery
- Rheumatoid Arthritis (RA)
- Traumatic etiology
- Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed.
- Altered pain perception and / or neurologic affection due to diabetes or other disorders.
- Patients will be excluded intraoperative if CR implant is not suitable.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital
Aalborg, DK-9000
Copenhagen University hospital, Gentofte
Copenhagen, DK-2900
Hvidovre hospital
Copenhagen
Dept. of Orthopaedic Surgery, Næstved Sygehus
Næstved, DK-4700
Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt
Vejle, DK-7100,
About this study
Official title: A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen Total Knee System in Total Knee Arthroplasty
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
Read the detailed description
Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee. There is an increasing demand for joint replacement in a younger population. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity. Studies have shown that modern implant designs can potentially improve outcome. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Within Total knee arthroplasty, design changes are introduced in an attempt to improve knee kinematics, functionality and outcome, but those potential improvements need to be evaluated.
The NexGen Total Knee System is a knee replacement system with well a documented performance and has been the device of choice in many institutions. Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Such design changes and proposed benefits need to be evaluated in a prospective clinical trial, with focus on patient safety, satisfaction and implant durability.
The aim is to evaluate intra-operative and postop complications, long-term survivorship and patient reported outcome measures following primary total knee replacement using Persona Cruciate Retaining (CR) total Knee system compared to NexGen Cruciate Retaining (CR) total Knee System.
This project is carried out as a 2-arm randomized controlled single-blinded trial. A total of 314 participants are to be included at 6 centers in Denmark. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After 2-year follow-up the patients will be followed for survivorship through the Danish Knee Arthroplasty Registry.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Persona total knee system, Nexgen total knee system
- Keywords
- Knee arthroplasty, Knee function, Total knee replacement, Persona total knee system, NexGen total knee system
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona total knee systemDevice
Also called Zimmer Biomet Persona total knee system
314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
Nexgen total knee systemDevice
Also called Zimmer Biomet Nexgen total knee system
314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
| Study group | Role | What they receive |
|---|---|---|
| Persona CR | Active comparator | Patients who received a Persona CR total knee implant Receives: Device: Persona total knee system |
| NexGen CR | Active comparator | Patients who received a NexGen CR total knee implant Receives: Device: Nexgen total knee system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
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: 3 months, 1 year and 2 years postoperatively
Secondary outcomes (9)
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score).
Measured: 3 months, 1 year and 2 years postoperatively
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 the joint 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 joint awareness, while a total score of 0 indicates the highest level of joint awareness.
Measured: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 1
Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?"
Measured: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 2
Patients were asked to answer the following satisfaction/anchoring question: "Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?"
Measured: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 3
Patients were asked to answer the following satisfaction/anchoring question: "If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?"
Measured: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 4
Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?"
Measured: 3 months, 1 year and 2 years postoperatively
EuroQol 5D (EQ-5D) Score
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 questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression.
For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead.
Measured: 3 months, 1 year and 2 years postoperatively
Radiolucency / Osteolysis
All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately.
Measured: Immediate postoperative and 3 months, 1 year and 2 years postoperatively
Long-term Survivorship
Registry data at 5, 7 and 10 years postoperatively.
Measured: 5, 7 and 10 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startDec 2016
- Primary completion23 Nov 2021
- Study completion31 Dec 2031 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Troelsen, Professor, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073941
- Sponsor's protocol ID
- K.CR.I.EU.15.13
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2017
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mortensen KRL, Ingelsrud LH, Odgaard A, Kappel A, Varnum C, Schroder H, Gromov K, Troelsen A. Patient-reported outcomes and complications of a new-generation total knee system: a randomized controlled trial. Acta Orthop. 2025 Feb 25;96:195-202. doi: 10.2340/17453674.2025.43004.
PubMed 39998994
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
- A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen Total Knee System in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03073941
- Acronym / sponsor ID
- K.CR.I.EU.15.13
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee arthroplasty, Knee function, Total knee replacement, Persona total knee system, NexGen total knee system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
Detailed description
Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee. There is an increasing demand for joint replacement in a younger population. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity. Studies have shown that modern implant designs can potentially improve outcome. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Within Total knee arthroplasty, design changes are introduced in an attempt to improve knee kinematics, functionality and outcome, but those potential improvements need to be evaluated.
The NexGen Total Knee System is a knee replacement system with well a documented performance and has been the device of choice in many institutions. Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Such design changes and proposed benefits need to be evaluated in a prospective clinical trial, with focus on patient safety, satisfaction and implant durability.
The aim is to evaluate intra-operative and postop complications, long-term survivorship and patient reported outcome measures following primary total knee replacement using Persona Cruciate Retaining (CR) total Knee system compared to NexGen Cruciate Retaining (CR) total Knee System.
This project is carried out as a 2-arm randomized controlled single-blinded trial. A total of 314 participants are to be included at 6 centers in Denmark. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After 2-year follow-up the patients will be followed for survivorship through the Danish Knee Arthroplasty Registry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persona CR | Active comparator | Device: Persona total knee systemPatients who received a Persona CR total knee implant |
| NexGen CR | Active comparator | Device: Nexgen total knee systemPatients who received a NexGen CR total knee implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
- >18 years of age
- Participants must be able to speak and understand Danish
- Participants must be able to give informed consent and be cognitively intact
- Participants must be able to complete all post-operative controls
Key exclusion criteria (7 listed)
- Terminal illness
- Revision knee replacement surgery
- Rheumatoid Arthritis (RA)
- Traumatic etiology
- Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed.
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 |
|---|---|---|
| Persona total knee systemAlso: Zimmer Biomet Persona total knee system314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen | Device | Persona CR |
| Nexgen total knee systemAlso: Zimmer Biomet Nexgen total knee system314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen | Device | NexGen CR |
Primary outcome
Oxford Knee Score
Time frame: 3 months, 1 year and 2 years postoperatively
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
9 secondary outcomes
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
Time frame: 3 months, 1 year and 2 years postoperatively
Forgotten Joint Score (FJS)
Time frame: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 1
Time frame: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 2
Time frame: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 3
Time frame: 3 months, 1 year and 2 years postoperatively
Patient Satisfaction and Anchoring Questions - Question 4
Time frame: 3 months, 1 year and 2 years postoperatively
EuroQol 5D (EQ-5D) Score
Time frame: 3 months, 1 year and 2 years postoperatively
Radiolucency / Osteolysis
Time frame: Immediate postoperative and 3 months, 1 year and 2 years postoperatively
Long-term Survivorship
Time frame: 5, 7 and 10 years postoperatively.
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.
- Derived from this study: PubMed 39998994Mortensen KRL, Ingelsrud LH, Odgaard A, Kappel A, Varnum C, Schroder H, Gromov K, Troelsen A. Patient-reported outcomes and complications of a new-generation total knee system: a randomized controlled trial. Acta Orthop. 2025 Feb 25;96:195-202. doi: 10.2340/17453674.2025.43004.
- 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, Professor principal investigator
Hvidovre University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persona total knee system and Nexgen total knee system in people with Osteoarthritis, Knee, run by Zimmer Biomet at 5 sites in Denmark.
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 7 inclusion and 7 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 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 5 sites in Denmark. 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 17 Jan 2025). 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?
Oxford Knee Score (time frame: 3 months, 1 year and 2 years postoperatively). 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 NCT03073941, 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 12 May 2026.