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Completed

NCT Number: NCT05038670

Journey II vs Persona Knee Systems - RCT

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 04-749, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee replacement

Device

Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2021
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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