Persona SoluTion PPS Femur PMCF
Key facts
- Who runs it
- Zimmer Biomet
- Where
- Baltimore, Cleveland, Denver, and Louisville, United StatesSee the 5 sites
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 200 people, planned
- Started
- 26 Feb 2026
- Expected to end
- Dec 2037
- Type of study
- Observational, 3 groups
- Treatments tested
- Total knee arthroplasty
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- Patient is currently participating in any other surgical intervention or pain management 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
- Study device not implanted during surgery, or surgery did not occur
- 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
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition
- Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
- Neuropathic arthropathy
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- KOOS JR score not collected pre-operatively
Where in United States
- MedStar Health Research InstituteBaltimore, United StatesEnrolling by invitation
- Cleveland Clinic FoundationCleveland, United StatesEnrolling by invitation
- AdventHealth PorterDenver, United StatesEnrolling by invitation
- Denver Hip and Knee, Inc.Denver, United StatesEnrolling by invitation
- Norton Orthopedic InstituteLouisville, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- 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.
Treatment: 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.
Treatment: 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.
Treatment: Total knee arthroplasty
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur
- Record updated
- 5 November 2026