Clinical Outcomes of MP Persona vs. Persona Knee-PS

NCT03681977 | Enrolling By Invitation FDA Device

• 1 other identifier: CODIM-MBM-17-162
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee

Keywords

Total Knee Arthroplasty; Medial Pivot Knee Implant Design; Knee Joint Mechanics

Outcome Measures

Primary Outcomes (1)

• Knee mechanics

  nee motion will be assessed using 3-dimensional optical motion capture sampled at 100 Hz, floor and step mounted force plates sampled at 2000 Hz, and wireless 16-channel electromyography (EMG) system sampled at 2000 Hz. Knee motion trials will require participants to ambulate at self-selected speeds over 8 meters followed by complete step up/down trials on a 20 cm step. For step up, the surgical limb will be placed on the step to start while for step down, both limbs will start on the step. The order of step up and down trials will be randomized. Participants will perform 2 practice trials followed by testing. Testing will proceed until 5 successful trials of each activity are collected. They will be allowed 30 seconds of rest between trials. The primary motion capture variables will include principal component scores that capture changes in range of motion for knee rotation and flexion angles for each activity.

  pre-operative (as baseline) and at 1 and 2 years following TKA

Secondary Outcomes (10)

• Muscle activation

  pre-operative (as baseline) and at 1 and 2 years following TKA

• The 30 seconds Chair Test - Physical Function Performance Test

  at 1 and 2 years following TKA

• The Stair Climb Test - Physical Function Performance Test

  at 1 and 2 years following TKA

• The 6 Minutes Walk Test - Physical Function Performance Test

  at 1 and 2 years following TKA

• Knee Osteoarthritis and Outcome Score (KOOS) Self-Evaluation Questionnaire for Implant Performance

  pre-operative (as baseline) and at 1 and 2 years following TKA

Other Outcomes (1)

• Maximum Voluntary Isometric Contractions (MVIC)

  pre-operative (as baseline) and at 1 and 2 years following TKA

Study Arms (3)

Zimmer MP Persona

EXPERIMENTAL

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

Device: Zimmer MP Persona

Zimmer Persona Knee-PS

ACTIVE COMPARATOR

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.

Device: Zimmer Persona Knee-PS

Healthy Participants

NO INTERVENTION

The control group for the kinematic assessment

Interventions

Zimmer MP Persona DEVICE

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

Also known as: Medial Pivot Persona, Persona knee implant with a Medial Congruent Bearing

Zimmer MP Persona

Zimmer Persona Knee-PS DEVICE

Persona the personalized knee system

Zimmer Persona Knee-PS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lady Davis Institute: lead
• Jewish General Hospital: collaborator
• McGill University: collaborator
• Zimmer Biomet: collaborator
• Montreal General Hospital: collaborator

Study Sites (3)

Montreal General Hospital

Montreal, PQ, H3G 1A4, Canada

Location

Lethbridge-Layton-MacKay Rehabilitation Centre

Montreal, PQ, H4B 1T3, Canada

Location

Jewish General Hospital

Montreal, PQ, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• John Antoniou, MD, PhD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Participants and the researchers at the Constance Lethbridge Rehabilitation Centre responsible for collecting the kinematic and gait data (motion capture, questionnaires, performance measures) will be blinded. For analysis purposes the Participants will be dummy coded (0 = one group, 1 = the other group). The blinded parties will know the dummy code but they will not know which group is assigned to each code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Director of the Division of Orthopaedic Surgery McGill University, Profesor of Surgery McGill University.

Model Details: A prospective, double-blinded, randomized control study consisting of a clinical follow-up followed by a knee kinematics assessment. Patients outcomes will be measured pre-operatively, and at 1 and 2 years post-surgery. 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.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: September 24, 2018
• Study Start: September 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)