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Journey II vs Persona Knee Systems - RCT

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Total Knee Replacement
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Othopedics and Rehabilitation, Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PERSONA

Journey II

Arm Description

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system

Outcomes

Primary Outcome Measures

Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
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.
Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
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.
Values of components rotation
Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks

Secondary Outcome Measures

Full Information

First Posted
August 25, 2021
Last Updated
August 31, 2021
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05038670
Brief Title
Journey II vs Persona Knee Systems - RCT
Official Title
Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant will not be informed which type of prosthesis was used in their particular case. Outcomes Assessor, who will be not present during surgery, will not be informed which type of prosthesis was used in particular patient.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PERSONA
Arm Type
Active Comparator
Arm Description
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
Arm Title
Journey II
Arm Type
Active Comparator
Arm Description
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system
Intervention Type
Device
Intervention Name(s)
Total Knee Replacement
Intervention Description
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
Primary Outcome Measure Information:
Title
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
Description
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.
Time Frame
baseline (preoperatively) and 1 year postoperatively
Title
Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
Description
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.
Time Frame
baseline (preoperatively) and 1 year postoperatively
Title
Values of components rotation
Description
Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks
Time Frame
1-day postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Artur Stolaerczyk, MD, PhD
Organizational Affiliation
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Othopedics and Rehabilitation, Medical University of Warsaw
City
Warsaw
State/Province
Mazovia
ZIP/Postal Code
04-749
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Journey II vs Persona Knee Systems - RCT

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