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Prosthesis

Knee Replacement Types for Osteoarthritis (MP-Persona Trial)

N/A

Waitlist Available

Led By John Antoniou, MD, PhD

Research Sponsored by Lady Davis Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females between 18 - 80 years at the time of surgery

Be older than 18 years old

Must not have

Patients with inflammatory arthritis, severe neurological conditions, or severe cardiovascular conditions

The presence of previous failed lower extremity arthroplasty or metalwork in situ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 2 years following tka

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the clinical effectiveness of two different types of knee replacements, specifically looking at whether or not one provides a better "natural feeling" to the patient.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from both devices may include pain at the surgery site, swelling, stiffness in the joint area, infection risk around the implant, blood clots in legs or lungs post-surgery and possible allergic reactions to materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe arthritis, neurological, or heart conditions.

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

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I have severe hip osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative (as baseline) and at 1 and 2 years following tka

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative (as baseline) and at 1 and 2 years following tka

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative (as baseline) and at 1 and 2 years following tka for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee

Secondary study objectives

Adverse Events

EQ-5D-5L Self-Evaluation Questionnaire for Implant Performance

Global Rating of Change (GRC) Self-Evaluation Questionnaire for Implant Performance

+7 more

Other study objectives

Maximum Voluntary Isometric Contractions (MVIC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 4Eligibility criteria met