Rhematoid ArthritisNCT07286513
Persona SoluTion PPS Femur PMCF
An observational study of Rhematoid Arthritis and Osteo Arthritis of the Knee, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis)
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2026to Dec 2037
- Phase
- Observational
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: The study population should be a consecutive series of subjects implanted with the Persona® SoluTion® PPS Femurs along with the corresponding Vivacit-E polyethylene articulating surface that meet the inclusion and exclusion criteria. To avoid selection bias, each Investigator will prospectively offer study participation to each consecutive potential and eligible patient for primary TKA using the commercially available Persona® SoluTion device. Bilateral patients requiring simultaneous surgical treatment will not be included in this study.
Who may be able to join
- Patient is of legal age of consent and skeletally mature
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
- Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- Patient qualifies for total knee arthroplasty based upon physical exam and medical history and meets the approved indications for use of the Persona® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort).
- A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research
Who cannot join
- Patient is currently participating in any other surgical intervention or pain management study
- Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
- Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
- Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
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- 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
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- Study device not implanted during surgery, or surgery did not occur
- KOOS JR score not collected pre-operatively
- Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Medstar Health Research Institute
Baltimore, Maryland, 21218
Denver Hip and Knee, Inc.
Denver, Colorado, 80134
AdventHealth Porter
Denver, Colorado, 80210
Norton Orthopedic Institute
Louisville, Kentucky, 40241
About this study
Official title: A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur
The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR.
The target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU).
The primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.
- Conditions
- Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis, Collagen Disorders, Avascular Necrosis of Femoral Condyle
- Being tested
- Total knee arthroplasty
- Keywords
- Total Knee, Total knee arthroplasty, Knee replacement
- Medical subject headings
- Disease, Arthritis, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDevice
Also called Total Knee replacement
The screening population will consist of patients for whom clinical decision has been made to use the Persona® SoluTion® PPS femoral implant in total knee arthroplasty prior to enrollment in the research.
| Study group | Role | What they receive |
|---|---|---|
| Persona® SoluTion PPS CR Femur with MC Bearing, cementless | This cohort will consist of subjects who receive the Persona® SoluTion PPS Cruciate Retaining Femur with the Medial Congruent Bearing, with cementless fixation. Receives: Device: Total knee arthroplasty | |
| Persona® SoluTion PPS PS Femur with PS Bearing, cementless | This cohort will consist of subjects who receive the Persona® SoluTion PPS Posterior Stabilized Femur with the Posterior Stabilized Bearing, with cementless fixation. Receives: Device: Total knee arthroplasty | |
| Persona® SoluTion PPS CR or PS Femur, cemented | This cohort will consist of subjects who receive the either the Persona® SoluTion PPS Cruciate Retaining Femur (with the Medial Congruent Bearing) or Posterior Stabilized Femur (with the Posterior Stabilized Bearing), with cemented fixation. Receives: Device: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KOOS JR Score between pre-op and 2 years post-op
A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function).
Measured: 2 years
Secondary outcomes (7)
KOOS JR Score
A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function).
Measured: 5 years
Oxford Knee Score (OKS)
A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations.
Measured: 5 years
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
The EQ-5D-5L instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire produces an "index" score that ranges from 0 to 1, where 0 is the value of a health state equivalent to dead; and 1 is the value of full health, with higher scores indicating higher health utility. The EQ VAS is a 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion. 100 indicates the best health imaginable and 0 indicates the worst health imaginable. Change in Index and EQ VAS scores will be compared from baseline to 2-year follow-up as well as from baseline to 5-year postoperative follow-up for each cohort. This change will also be compared between the cohorts.
Measured: 5 years
Numeric Rating Scale (Pain)
The 11-item pain NRS asks patients to rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). It is the most widely used instrument for pain screening with higher scores indicating greater pain intensity.
Measured: 5 years
Survival Rate of Implant
Survival Rate (Survivorship) will be both assessed by revision/additional surgeries to the affected joint due to aseptic loosening only or by revision, removal, exchange of the implanted device due to any reason. Aseptic loosening and other reasons for additional surgeries may be identified by radiographic imaging.
Measured: 10 years
Frequency and types of Adverse Events
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
Measured: 10 years
Assessment of the prevalence of metal hypersensitivities using a metal Lymphocyte Transformation Test (LTT)
The Orthopedic Panel 2 tests for hypersensitivity to aluminum, cobalt, chromium, iron, molybdenum, nickel, vanadium, zirconium, titanium alloy particles, cobalt alloy particles, bone cement particles, and bone cement liquid.
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 posted16 Dec 2025
- Study start26 Feb 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhematoid ArthritisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286513
- Sponsor's protocol ID
- CMU2025-04K
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided