Persona SoluTion PPS Femur PMCF

Enrolling by invitation

Conditions studied: Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis, Collagen Disorders, Avascular Necrosis of Femoral Condyle, Valgus Deformity, Varus Deformity, Flexion Deformity of Knee

In brief

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.

Key facts

Study ID

NCT07286513

Run by

Zimmer Biomet

People needed

200

Starts

2026-02-26

Expected to finish

2037-12-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Denver Hip and Knee, Inc. — Denver, Colorado, United States
• Medstar Health Research Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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