Journey II vs Persona Knee Systems - RCT

August 31, 2021 updated by: Artur Stolarczyk, Medical University of Warsaw

Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial

This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.

To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.

Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.

1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazovia
      • Warsaw, Mazovia, Poland, 04-749
        • Department of Othopedics and Rehabilitation, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
  • Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
  • Aged 18 or over
  • Patient willing to provide full informed consent to the trial

Exclusion Criteria:

  • Listed for a single-stage bilateral TKR procedure
  • Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
  • Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
  • Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
  • Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
  • Inflammatory arthritis
  • Previous septic arthritis in the affected knee joint
  • Previous surgery to the collateral ligaments of the affected knee
  • Patients on warfarin or novel oral anticoagulants (NOACs)
  • Will not be resident in the catchment area for at least 6 months post-surgery
  • Undertaking the surgery as a private patient
  • Patients who, in the opinion of the clinical staff, do not have capacity to consent
  • Patients who are pregnant
  • Unable to understand written and spoken Polish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PERSONA
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
Device: Total Knee Replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
Active Comparator: Journey II
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system
Device: Total Knee Replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
Time Frame: baseline (preoperatively) and 1 year postoperatively
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 100, with higher scores corresponding to better outcomes.
baseline (preoperatively) and 1 year postoperatively
Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
Time Frame: baseline (preoperatively) and 1 year postoperatively
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 96, with higher scores corresponding to worse outcomes.
baseline (preoperatively) and 1 year postoperatively
Values of components rotation
Time Frame: 1-day postoperatively
Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks
1-day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Artur Stolaerczyk, MD, PhD, Department of Orthopedics and Rehabilitation, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

November 24, 2020

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WarsawMU/persona

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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