Osteoarthritis ArthritisNCT02269254
Persona Versus NexGen
A study testing Persona PS Knee Prosthesis by Zimmer and NexGen PS Knee Prosthesis by Zimmer in people with Osteoarthritis Arthritis and Joint Diseases, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Osteoarthritis Arthritis, Joint Diseases, Musculoskeletal Diseases
- What is being tested?
- Persona PS Knee Prosthesis by Zimmer and NexGen PS Knee Prosthesis by Zimmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty
- Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Stratification is performed per diagnosis group (OA/RA).
Who cannot join
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- Insufficient Dutch or English language skills
- Patients indicated for revision arthroplasty
- Patient is (or might be) pregnant
- When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). In case only one of the bones has insufficient markers, the patient will be followed for the other bone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy
The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet.
The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures.
Read more
This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis.
Different sample sizes are used for the different parts of this study:
- 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA
- 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period.
Main study parameters/endpoints are:
- Migration, measured by means of RSA.
- Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts.
- In vivo kinematics by means of fluoroscopy.
- Patient Reported Outcome Measures by means of questionaires.
- Being tested
- Persona PS Knee Prosthesis by Zimmer, NexGen PS Knee Prosthesis by Zimmer
- Keywords
- Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-Up Studies, Arthroplasty, Replacement, Knee/methods
- Medical subject headings
- Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona PS Knee Prosthesis by ZimmerDevice
Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer
NexGen PS Knee Prosthesis by ZimmerDevice
Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer
| Study group | Role | What they receive |
|---|---|---|
| Persona PS | Experimental | Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer Receives: Device: Persona PS Knee Prosthesis by Zimmer |
| NexGen PS | Active comparator | Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer Receives: Device: NexGen PS Knee Prosthesis by Zimmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration, measured by means of RSA.
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
Measured: 2 Years
Secondary outcomes (4)
Knee Prosthesis motion by means of Fluoroscopy.
Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis.
Measured: 1 Year
EQ-5D
General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire
Measured: 2 Years
KOOS
Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire
Measured: 2 Years
VAS pain
Pain score after activity and during rest; (Likert scale 0-10)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2019
- Study completionJun 2019
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 Osteoarthritis ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, R.G.H.H. Nelissen, Leiden University Medical Center
- Investigators
- Rob GHH Nelissen, Prof. PhD, MD, Principal investigator, Dep. Orthopaedics, Leiden University Medical CenterEdward R Valstar, Prof. PhD. MSc, Principal investigator, Dep. Orthopaedics, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269254
- Sponsor's protocol ID
- P13.277
- Status last verified
- Feb 2020
- First submitted
- 23 Sep 2014
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
de Laat NN, Koster LA, Robertson JE, Nelissen RGHH, Kaptein BL. Clinical Validation and Excellent Interobserver Agreement of Volumetric Matching Micromotion Analysis (V3MA) in Total Knee Arthroplasty. J Orthop Res. 2026 Jan;44(1):e70049. doi: 10.1002/jor.70049. Epub 2025 Aug 24.
PubMed 40849786
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy
- ClinicalTrials.gov ID
- NCT02269254
- Acronym / sponsor ID
- P13.277
- Keywords
- Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-Up Studies, Arthroplasty, Replacement, Knee/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 21 Oct 2014 (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 NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet.
The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures.
This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis.
Different sample sizes are used for the different parts of this study:
- 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA
- 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period.
Main study parameters/endpoints are:
- Migration, measured by means of RSA.
- Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts.
- In vivo kinematics by means of fluoroscopy.
- Patient Reported Outcome Measures by means of questionaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persona PS | Experimental | Device: Persona PS Knee Prosthesis by ZimmerTotal Knee Replacement with Persona PS Knee Prosthesis by Zimmer |
| NexGen PS | Active comparator | Device: NexGen PS Knee Prosthesis by ZimmerTotal Knee Replacement with NexGen PS Knee Prosthesis by Zimmer |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty
- Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Stratification is performed per diagnosis group (OA/RA).
Key exclusion criteria (5 listed)
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- Insufficient Dutch or English language skills
- Patients indicated for revision arthroplasty
- Patient is (or might be) pregnant
- When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). In case only one of the bones has insufficient markers, the patient will be followed for the other bone.
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 PS Knee Prosthesis by ZimmerTotal Knee Replacement with Persona PS Knee Prosthesis by Zimmer | Device | Persona PS |
| NexGen PS Knee Prosthesis by ZimmerTotal Knee Replacement with NexGen PS Knee Prosthesis by Zimmer | Device | NexGen PS |
Primary outcome
Migration, measured by means of RSA.
Time frame: 2 Years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
4 secondary outcomes
Knee Prosthesis motion by means of Fluoroscopy.
Time frame: 1 Year
EQ-5D
Time frame: 2 Years
KOOS
Time frame: 2 Years
VAS pain
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 40849786de Laat NN, Koster LA, Robertson JE, Nelissen RGHH, Kaptein BL. Clinical Validation and Excellent Interobserver Agreement of Volumetric Matching Micromotion Analysis (V3MA) in Total Knee Arthroplasty. J Orthop Res. 2026 Jan;44(1):e70049. doi: 10.1002/jor.70049. Epub 2025 Aug 24.
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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.
Rob GHH Nelissen, Prof. PhD, MD principal investigator
Dep. Orthopaedics, Leiden University Medical Center
Edward R Valstar, Prof. PhD. MSc principal investigator
Dep. Orthopaedics, Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persona PS Knee Prosthesis by Zimmer and NexGen PS Knee Prosthesis by Zimmer in people with Osteoarthritis Arthritis and Joint Diseases, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 inclusion and 5 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Migration, measured by means of RSA. (time frame: 2 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 NCT02269254, 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 11 Feb 2020.