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Enrolling by invitation NCT07286513

Persona SoluTion PPS Femur PMCF

— Observational Rhematoid Arthritis Osteo Arthritis of the Knee Traumatic Arthritis of Knee (Diagnosis) Polyarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total knee arthroplasty.
Who it may be relevant to
Registry conditions: Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Change in KOOS JR Score between pre-op and 2 years post-op [Time frame: 2 years]
Secondary outcome measures (7)
  • KOOS JR Score [Time frame: 5 years]
  • Oxford Knee Score (OKS) [Time frame: 5 years]
  • EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire [Time frame: 5 years]
  • Numeric Rating Scale (Pain) [Time frame: 5 years]
  • Survival Rate of Implant [Time frame: 10 years]
  • Frequency and types of Adverse Events [Time frame: 10 years]
  • Assessment of the prevalence of metal hypersensitivities using a metal Lymphocyte Transformation Test (LTT) [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • Patient is of legal age of consent and skeletally mature
  • Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
  • Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
  • 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).
  • A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research

Exclusion criteria

  • Patient is currently participating in any other surgical intervention or pain management study
  • Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
  • Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
  • 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
  • Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
  • Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
  • Insufficient bone stock on femoral or tibial surfaces
  • Skeletal immaturity
  • Neuropathic arthropathy
  • Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
  • A stable, painless arthrodesis in a satisfactory functional position
  • Severe instability secondary to the absence of collateral ligament integrity
  • Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
  • Study device not implanted during surgery, or surgery did not occur
  • KOOS JR score not collected pre-operatively
  • Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Denver Hip and Knee, Inc. — Denver
  • Medstar Health Research Institute — Baltimore

Identifiers

NCT: NCT07286513 · CMU2025-04K

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗