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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years following tka
Awards & highlights
MP-Persona Trial 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.Check my eligibility
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.See study design
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.
MP-Persona Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
MP-Persona Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Knee
Secondary outcome measures
Adverse Events
EQ-5D-5L Self-Evaluation Questionnaire for Implant Performance
Global Rating of Change (GRC) Self-Evaluation Questionnaire for Implant Performance
+7 moreOther outcome measures
Maximum Voluntary Isometric Contractions (MVIC)
MP-Persona 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
Find a Location
Who is running the clinical trial?
McGill UniversityOTHER
394 Previous Clinical Trials
998,219 Total Patients Enrolled
Zimmer BiometIndustry Sponsor
373 Previous Clinical Trials
67,233 Total Patients Enrolled
130 Trials studying Osteoarthritis
33,124 Patients Enrolled for Osteoarthritis
Montreal General HospitalOTHER
17 Previous Clinical Trials
9,875 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe arthritis, neurological, or heart conditions.I have had a failed leg joint replacement or metal implants in my leg.I am willing and able to follow all study requirements.I have severe hip osteoarthritis.I understand the study's conditions and agree to participate.I need surgery for a leg injury within the year.I have osteoarthritis and am a good candidate for a total knee replacement.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Zimmer Persona Knee-PS
- Group 2: Healthy Participants
- Group 3: Zimmer MP Persona
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research experiment open to new participants at present?
"According to clinicaltrials.gov, the trial is not presently recruiting new patients; this investigation was initially posted on September 1st 2019 and its details were last edited on September 16th 2021. However, there are currently 456 other trials that require recruitment of participants."
Answered by AI
Are there any restrictions for individuals wishing to participate in this experiment?
"This medical trial is seeking 162 applicants with knee osteoarthritis aged between 18 and 80. Key inclusion criteria include: an official diagnosis of osteoarthritis; the capacity to participate in all assessments for the duration of the study period; and being a male/female within the specified age range at time of surgery."
Answered by AI
Are individuals aged 85 and over being accepted into this trial's participant pool?
"To participate in this medical study, patients must be between the ages of 18 and 80. There are 27 studies for minors, while those over 65 can select from 433 different clinical trials."
Answered by AI
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