NCT03568123

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

Completed NA Last updated 16 March 2022

What this trial tests

NA trial testing MC polyethylene bearing in Knee Osteoarthritis in 60 participants. Completed in 14 October 2021.

Timeline

5 July 2017

Primary endpoint
14 October 2021

14 October 2021

Quick facts

Lead sponsor	Anders Troelsen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	5 July 2017
Primary completion	14 October 2021
Estimated completion	14 October 2021
Sites	1 location across Denmark

Drugs / interventions tested

• MC polyethylene bearing
• CR polyethylene bearing

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Anders Troelsen

Who can join

18 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.