Persona SoluTion PPS Femur PMCF

Part of paid clinical trials in Denver, Colorado.

Sponsor
Zimmer Biomet
Study ID
NCT07286513
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total knee arthroplasty — DEVICE
    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.

Study Details

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 Dates

Start date
Feb 26, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2037

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Persona® SoluTion PPS CR Femur with MC Bearing, cementless
    This cohort will consist of subjects who receive the Persona® SoluTion PPS Cruciate Retaining Femur with the Medial Congruent Bearing, with cementless fixation.
  • Arm: Persona® SoluTion PPS PS Femur with PS Bearing, cementless
    This cohort will consist of subjects who receive the Persona® SoluTion PPS Posterior Stabilized Femur with the Posterior Stabilized Bearing, with cementless fixation.
  • Arm: Persona® SoluTion PPS CR or PS Femur, cemented
    This cohort will consist of subjects who receive the either the Persona® SoluTion PPS Cruciate Retaining Femur (with the Medial Congruent Bearing) or Posterior Stabilized Femur (with the Posterior Stabilized Bearing), with cemented fixation.

Primary Outcome Measure

Change in KOOS JR Score between pre-op and 2 years post-op [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Denver Hip and Knee, Inc.DenverColorado80134-

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By research site
Denver Hip and Knee, Inc.· Denver, CO

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