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Persona SoluTion PPS Femur PMCF

NCT07286513 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-26
Primary Completion
2029-12-31
Completion
2037-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286513 on ClinicalTrials.gov