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

No results posted yet for this study

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
  • McGill University

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03681977 on ClinicalTrials.gov