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 range18 Years
SexALL
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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
✕. 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)
✕
What they're measuring
1
Change in KOOS JR Score between pre-op and 2 years post-op
. 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