Persona SoluTion PPS Femur PMCF (NCT07286513) | Clinical Trial Compass
By InvitationNot Applicable
Persona SoluTion PPS Femur PMCF
United States200 participantsStarted 2026-02-26
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking a score called KOOS JR before surgery and then again two years later — what does that score actually measure, and how would my own baseline score today compare to what's considered a meaningful improvement?
2Since this trial is listed as 'enrolling by invitation only,' what would it mean for my care if I'm not invited to participate — would I still have access to the same Persona SoluTion knee implant, or is it only available through the study?
3This appears to be a post-market follow-up study rather than a traditional phase trial, which means the implant is already approved for use — does that change the risk profile compared to an experimental treatment, and are there any safety signals your team is already aware of from earlier use?
4Given that my specific diagnosis — whether it's rheumatoid arthritis, avascular necrosis, or a deformity — is one of the conditions this study covers, do you think my situation fits what the study is designed to track, or would a different treatment path make more sense for me first?
5Since the study runs for at least two years of follow-up, what kind of commitment would that involve in terms of visits, assessments, or reporting, and is that realistic given my current health and life circumstances?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in KOOS JR Score between pre-op and 2 years post-op
. 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
. Insufficient bone stock on femoral or tibial surfaces