A Comparison of the Persona Total Knee Arthroplasty System Using CR or MC Polyethylene

Summary

Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. 1961). Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Therefore such design changes and proposed benefits need to be evaluated in a prospective clinical trail, with focus on patient safety, satisfaction and implant durability.

In this project the investigators wish to:

Evaluate stability and fixation, intra-operative and postop complications, survivorship and patient reported outcome measures following primary total knee replacement using MC polyethylene bearing compared to CR polyethylene bearing with Persona Total Knee for treatment of knee osteoarthritis.

This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing are compared. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the Danish Data Protections Agency is obtained. A total of 60 participants are to be included at Hvidovre University Hospital. Recruitment is expected completed after a period of 1.5 year. The project is expected to be completed 2 years after recruitment of the last participant (2019).

Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. RSA is performed postoperatively and at all outpatient follow-ups. Dynamic RSA is performed at 1 year follow-up. The patients will be followed for survival through The Danish Knee Arthroplasty Registry.

This project is financed by Zimmer-Biomet®, Warsaw, Indiana, USA. The primary investigator of this project has independently initiated the project.

Conditions

• Knee Osteoarthritis

Interventions

DEVICE

MC polyethylene bearing

Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. Femoral component: Only cemented femoral components will be used for this study. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Tibial component: Only cemented tibial components will be used for this study. Polyethylene materials: Conventional polyethylene will be used for patients \>65 years old and Vitamine-E infused poly insert for patients ≤ 65 years old.

DEVICE

CR polyethylene bearing

Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Femoral component: Only cemented femoral components will be used for this study. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Tibial component: Only cemented tibial components will be used for this study. Polyethylene materials: Conventional polyethylene will be used for patients \>65 years old and Vitamine-E infused poly insert for patients ≤ 65 years old.

Sponsors & Collaborators

• Zimmer Biomet

  collaborator INDUSTRY

• Anders Troelsen

  lead OTHER

Principal Investigators

• Anders Troelsen, Professor · Department of orthopaedic surgery

• Kirill Gromov, PhD · Department of orthopaedic surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-05

Primary Completion

2021-10-14

Completion

2021-10-14

Countries

• Denmark

Study Locations