Clinical Outcomes of MP Persona vs. Persona Knee-PS

NCT ID: NCT03681977

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zimmer MP Persona

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 Type: EXPERIMENTAL

Zimmer MP Persona

Intervention Type: DEVICE

The medial pivot Persona® knee implant with a Medial Congruent™ Bearing

Zimmer Persona Knee-PS

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 Type: ACTIVE_COMPARATOR

Zimmer Persona Knee-PS

Intervention Type: DEVICE

Persona the personalized knee system

Healthy Participants

The control group for the kinematic assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zimmer MP Persona

The medial pivot Persona® knee implant with a Medial Congruent™ Bearing

Intervention Type: DEVICE

Zimmer Persona Knee-PS

Persona the personalized knee system

Intervention Type: DEVICE

Other Intervention Names

Medial Pivot Persona; Persona knee implant with a Medial Congruent Bearing

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Montreal General Hospital

OTHER

Sponsor Role: collaborator

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

John Antoniou, MD PhD

Principal Investigator, Research Director of the Division of Orthopaedic Surgery McGill University, Profesor of Surgery McGill University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Antoniou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

Montreal General Hospital

Montreal, PQ, Canada

Lethbridge-Layton-MacKay Rehabilitation Centre

Montreal, PQ, Canada

Jewish General Hospital

Montreal, PQ, Canada

Countries

Canada

Other Identifiers

CODIM-MBM-17-162

Identifier Type: -

Identifier Source: org_study_id