Trials / Not Yet Recruiting
Not Yet RecruitingNCT07286513
Persona SoluTion PPS Femur PMCF
A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-28
- Primary completion
- 2029-12-01
- Completion
- 2037-12-01
- First posted
- 2025-12-16
- Last updated
- 2026-02-27
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07286513. Inclusion in this directory is not an endorsement.