Clinical Outcomes of MP Persona vs. Persona Knee-PS
NCT03681977 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2024-07-12
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
Interventions
- 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
Sponsors & Collaborators
-
Jewish General Hospital
collaborator OTHER - collaborator OTHER
-
Zimmer Biomet
collaborator INDUSTRY -
Montreal General Hospital
collaborator OTHER -
Lady Davis Institute
lead OTHER
Principal Investigators
-
John Antoniou, MD, PhD · Jewish General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- Canada
Study Locations
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