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NCT07286513

Persona SoluTion PPS Femur PMCF

Sponsor: Zimmer Biomet

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.

Official title: A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-02-28

Completion Date

2037-12

Last Updated

2026-02-27

Healthy Volunteers

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 Flexion Deformity of Knee

Interventions

DEVICE

Total knee arthroplasty

The screening population will consist of patients for whom clinical decision has been made to use the Persona® SoluTion® PPS femoral implant in total knee arthroplasty prior to enrollment in the research.

Inclusion Criteria: 1. Patient is of legal age of consent and skeletally mature 2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. 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). 5. A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research Exclusion Criteria: 1. Patient is currently participating in any other surgical intervention or pain management study 2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent) 3. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions 4. 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 5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 6. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint 7. Insufficient bone stock on femoral or tibial surfaces 8. Skeletal immaturity 9. Neuropathic arthropathy 10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 11. A stable, painless arthrodesis in a satisfactory functional position 12. Severe instability secondary to the absence of collateral ligament integrity 13. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 14. Study device not implanted during surgery, or surgery did not occur 15. KOOS JR score not collected pre-operatively 16. Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition