Persona SoluTion PPS Femur PMCF

Zimmer Biomet

Status: Not yet enrolling

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

Treatments: Device: Total knee arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT07286513

CMU2025-04K

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is of legal age of consent and skeletally mature
2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
4. 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).
5. A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research

Exclusion criteria

1. Patient is currently participating in any other surgical intervention or pain management study
2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
3. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
4. 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
5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
6. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
7. Insufficient bone stock on femoral or tibial surfaces
8. Skeletal immaturity
9. Neuropathic arthropathy
10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
11. A stable, painless arthrodesis in a satisfactory functional position
12. Severe instability secondary to the absence of collateral ligament integrity
13. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
14. Study device not implanted during surgery, or surgery did not occur
15. KOOS JR score not collected pre-operatively
16. Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition

Trial design

200 participants in 3 patient groups

Persona® SoluTion PPS CR Femur with MC Bearing, cementless

Description:

This cohort will consist of subjects who receive the Persona® SoluTion PPS Cruciate Retaining Femur with the Medial Congruent Bearing, with cementless fixation.

Treatment:

Device: Total knee arthroplasty

Persona® SoluTion PPS PS Femur with PS Bearing, cementless

Description:

This cohort will consist of subjects who receive the Persona® SoluTion PPS Posterior Stabilized Femur with the Posterior Stabilized Bearing, with cementless fixation.

Treatment:

Device: Total knee arthroplasty

Persona® SoluTion PPS CR or PS Femur, cemented

Description:

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.

Treatment:

Device: Total knee arthroplasty