Persona SoluTion PPS Femur PMCF

NCT07286513 | Enrolling By Invitation FDA Device

• 1 other identifier: CMU2025-04K
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

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; Rhematoid Arthritis

Keywords

Total Knee; Total knee arthroplasty; Knee replacement

Outcome Measures

Primary Outcomes (1)

• Change in KOOS JR Score between pre-op and 2 years post-op

  A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function).

  2 years

Secondary Outcomes (7)

• KOOS JR Score

  5 years

• Oxford Knee Score (OKS)

  5 years

• EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire

  5 years

• Numeric Rating Scale (Pain)

  5 years

• Survival Rate of Implant

  10 years

Other Outcomes (3)

• Patient Expectations Pre- and Post-op

  5 years

• Patient Satisfaction Questionnaire

  5 years

• Assessment of Radiographic Outcomes

  10 years

Study Arms (3)

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.

Device: Total knee arthroplasty

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.

Device: Total knee arthroplasty

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.

Device: Total knee arthroplasty

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.

Also known as: Total Knee replacement

Persona® SoluTion PPS CR Femur with MC Bearing, cementless; Persona® SoluTion PPS CR or PS Femur, cemented; Persona® SoluTion PPS PS Femur with PS Bearing, cementless

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population should be a consecutive series of subjects implanted with the Persona® SoluTion® PPS Femurs along with the corresponding Vivacit-E polyethylene articulating surface that meet the inclusion and exclusion criteria. To avoid selection bias, each Investigator will prospectively offer study participation to each consecutive potential and eligible patient for primary TKA using the commercially available Persona® SoluTion device. Bilateral patients requiring simultaneous surgical treatment will not be included in this study.

You may qualify if:

• 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

You may not qualify if:

• Patient is currently participating in any other surgical intervention or pain management study
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Denver Hip and Knee, Inc.

Denver, Colorado, 80134, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients will take a blood draw for a metal -Lymphocyte Transformation Test (metal-LTT) test to be performed by Orthopedic Analysis, LLC.

MeSH Terms

Conditions

Disease; Arthritis; Collagen Diseases

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: February 26, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2037
• Last Updated: April 21, 2026

Record last verified: 2026-02

Locations

US (1)