NCT03681977

Clinical Outcomes of MP Persona vs. Persona Knee-PS

The Influence of Medial Pivot Knee Arthroplasty Implant Design on Joint Mechanics, Muscle Activation and Clinical Outcomes

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Lady Davis Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Zimmer MP Persona	The medial pivot Persona® knee implant with a Medial Congruent™ Bearing
DEVICE	Zimmer Persona Knee-PS	Persona the personalized knee system

Timeline

• Start date: 2019-09-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2018-09-24
• Last updated: 2024-07-12

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated device study