Clinical Trial

Persona SoluTion PPS Femur PMCF

Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-04-22
Trial Details
NCT Number NCT07286513
Lead Sponsor Zimmer Biomet
Conditions Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis, Collagen Disorders, Avascular Necrosis of Femoral Condyle, Valgus Deformity, Varus Deformity +1 more
Enrollment 200 participants
Start Date 2026-02-26
Primary Completion 2029-12 (estimated)
Study Completion 2037-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-08