Clinical Outcomes of MP Persona vs. Persona Knee-PS (MP-Persona)

Lady Davis Institute

Status: Invitation-only

Conditions: Osteoarthritis, Knee

Treatments: Device: Zimmer MP Persona; Device: Zimmer Persona Knee-PS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03681977

CODIM-MBM-17-162

Details and patient eligibility

About

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.

Full description

This is a prospective, double-blinded, randomized control study comparing the TKA Zimmer Medial Pivot Persona design to the traditional Zimmer Persona Knee-PS. Eighty patients requiring a TKA will be recruited and randomized to one of the two treatment arms following confirmation of eligibility criteria. Forty age and sex matched healthy participants with no knee OA will also be recruited to provide a comparator measure of "normal" joint motion.

Clinical follow-up visits and radiographic assessments will be performed pre- and post-operative at 6-weeks, 1-year, 2-years. Knee kinematics and self-assessment will be completed at the following intervals: pre-operative as baseline assessments for knee motion, 1-year, 2-years. Measures will include joint mechanics and neuromuscular activation during walking and stair stepping measured with motion capture and electromyography, and clinical/self assessment including pain in response to physical activity. Any other adverse events and complications (i.e, implant failure, re-operation, infection) will be record throughout the study.

Healthy participants will only be assessed once to provide normative data.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals diagnosed with osteoarthritis, who in the opinion of the investigator, are suitable candidates for primary total knee replacement using the devices specified in the protocol;
• Males and females between 18 - 80 years at the time of surgery;
• Individuals who understand the conditions of the study and are willing and able to provide informed consent for participation in the study;
• Individuals who are willing and able to participate for the length of the prescribed term of follow-up;
• Individuals who are willing and able to complete all the assessments specified by the study protocol.

Exclusion criteria

• The presence of previous failed lower extremity arthroplasty or metalwork in situ;
• Patients with severe hip osteoarthritis;
• Patients with lower extremity trauma requiring surgery within 1 year;
• Patients with inflammatory arthritis, severe neurological conditions, or severe cardiovascular conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 3 patient groups

Zimmer MP Persona

Experimental group

Description:

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

Treatment:

Device: Zimmer MP Persona

Zimmer Persona Knee-PS

Active Comparator group

Description:

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.

Treatment:

Device: Zimmer Persona Knee-PS

Healthy Participants

No Intervention group

Description:

The control group for the kinematic assessment