An observational study in Rhematoid Arthritis, Osteo Arthritis of the Knee and Traumatic Arthritis of Knee (Diagnosis), sponsored by Zimmer Biomet. Enrolling by invitation at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Zimmer Biomet · Observational
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.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 200 is above the median of 151 across 202 observational studies indexed under Arthritis.
Browse Arthritis studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Compared within Arthritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will consist of subjects who receive the Persona® SoluTion PPS Cruciate Retaining Femur with the Medial Congruent Bearing, with cementless fixation.
Device: Total knee arthroplasty
This cohort will consist of subjects who receive the Persona® SoluTion PPS Posterior Stabilized Femur with the Posterior Stabilized Bearing, with cementless fixation.
Device: Total knee arthroplasty
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.
Device: Total knee arthroplasty
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.
Also known as: Total Knee replacement
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).
Time frame: 2 years
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 years
Patient Expectations Pre- and Post-op
Per the 2011 Knee Society scoring manual: "\[This\] is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function." Higher scores preoperatively indicate more positive expectations of the patient's total knee replacement surgery, and higher scores postoperatively indicate the level to which a patient's pre-op expectations have been met.
Time frame: 5 years
Patient Satisfaction Questionnaire
A three-question Patient Satisfaction Questionnaire. The questions include general satisfaction, level of pain, and a hypothetical question about whether the patient would do the surgery again.
Time frame: 5 years
Assessment of Radiographic Outcomes
Radiographic parameters to be evaluated include, but are not limited to, radiolucencies, osteolysis, hypertrophy, subsidence, and heterotopic ossification. All radiographic evaluations performed according to the protocol will be reviewed by the investigator at the time of the evaluation for significant radiographic findings.
Time frame: 10 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2029, 46 months after the start.
Of 87 observational studies under Arthritis, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 223. This study's planned 46 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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