Knee Replacement Types for Osteoarthritis (MP-Persona Trial)

Palo Alto (17 mi)

Overseen byJohn Antoniou, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Lady Davis Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. However, an increasing number of patients are complaining about their TKA due to altered sensations between their previous joint and the implant. Although several designs have been proposed to improve these outcomes, the knee kinematics after TKA remains different from physiological kinematics. The Medial Pivot TKA design was introduced to closely mimic normal knee kinematics and create the natural feeling of the knee. This study is intended to evaluate the clinical effectiveness and ability to restore knee motion of two TKA devices: the Medial Pivot Persona TKA Zimmer design with the traditional Zimmer Persona Knee-PS. The investigator's hypothesis is that the Medial Pivot design will results in better patient outcomes and restore knee motion at natural parameters.

Eligibility Criteria

This trial is for adults aged 18-80 with knee osteoarthritis who need a total knee replacement and can follow the study's procedures. They must understand and consent to the study, but cannot join if they have inflammatory arthritis, severe neurological or cardiovascular conditions, previous failed leg surgeries, severe hip OA, or recent leg trauma.

Inclusion Criteria

I am between 18 and 80 years old.

Exclusion Criteria

I have severe arthritis, neurological, or heart conditions.

I have had a failed leg joint replacement or metal implants in my leg.

I have severe hip osteoarthritis.

Treatment Details

The trial compares two types of total knee replacements: Zimmer MP Persona (a new design aiming to mimic natural knee motion) versus the traditional Zimmer Persona Knee-PS. The goal is to see which one gives better patient outcomes and more natural-feeling knee movement after surgery.

3Treatment groups

Experimental Treatment

Active Control

Group I: Zimmer MP PersonaExperimental Treatment1 Intervention

Zimmer MP Persona is total knee prosthesis intended to resurface the articulating surface of the femoral, tibial and patellar bones. It employs modular components between the tibial plates and articular surfaces and a medial congruent bearing manufactured from Vivacit-E Highly Crosslinked Polyethylene (HXPE). Persona® Medial Congruent Bearing is available in several sizes and offers up to a 13mm anterior lip height to provide greater anterior constraint and subluxation resistance. Can be used with a with both cruciate retaining and posterior stabilized femoral provisionals

Group II: Zimmer Persona Knee-PSActive Control1 Intervention

Zimmer Biomet Persona® Knee-PS is a semiconstrained knee prosthesis that employs modular components between the tibial plates and articular surfaces. The device is intended to resurface the articulating surface of the femoral, tibial and patellar bones. The posterior stabilized (PS) femoral provisionals and components can be used with the PS or constrained posterior stabilized (CPS) bearings provisionals and components when the PCL is deficient and removed.The Persona Femur offers 21 distinct profiles, in 2 mm increments.

Group III: Healthy ParticipantsActive Control1 Intervention

The control group for the kinematic assessment