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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04461626
Registration number
NCT04461626
Ethics application status
Date submitted
1/07/2020
Date registered
8/07/2020
Date last updated
11/07/2023
Titles & IDs
Public title
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
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Scientific title
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
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Secondary ID [1]
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CSA2014-02K
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)
Persona fixed bearing knee system - Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system)
Treatment: Devices: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Implant Survivorship
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Assessment method [1]
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Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
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Timepoint [1]
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Up to 5 years post surgery
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Primary outcome [2]
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Adverse Events (Safety)
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Assessment method [2]
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Safety based on incidence and frequency of adverse events
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Timepoint [2]
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Up to 5 years post surgery
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Primary outcome [3]
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Clinical Performance
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Assessment method [3]
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Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score
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Timepoint [3]
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Up to 5 years post surgery
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Primary outcome [4]
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Clinical Performance
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Assessment method [4]
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Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee
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Timepoint [4]
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Up to 5 years post surgery
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Eligibility
Key inclusion criteria
- Age 18 to 80 years old, inclusive
- Qualifies for a primary TKA based on physical exam and medical history, including
diagnosis of severe knee pain and disability due to at least one of the following:
1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
2. Collagen disorders and/ or avascular necrosis of femoral condyle.
3. Post-traumatic loss of joint configuration, particularly when there is
patellofemoral erosion, dysfunction or prior patellectomy.
4. Moderate valgus, varus or flexion deformities.
5. The salvage of previously failed surgical attempts that did not include partial
or total knee arthroplasty of the ipsilateral knee.
- Participated in a study-related informed consent process.
- Willing and able to provide written informed consent by signing and dating the IRB/EC
approved informed consent form.
- Willing and able to complete scheduled study procedures and follow-up evaluations.
- Independent of study participation, patient is a candidate for commercially available
Persona fixed bearing knee system implanted in accordance with product labelling.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
- Currently participating in any other surgical intervention studies or pain management
studies.
- Previous history of infection in the affected joint and/or other local/systemic
infection that may affect the prosthetic joint.
- Insufficient bone stock on femoral or tibial surfaces/
- Skeletal immaturity
- Neuropathic arthropathy
- Any loss of musculature or neuromuscular disease that compromises the affected limb.
- Stable, painless arthrodesis in a satisfactory functional position.
- Severe instability secondary to the absence of collateral ligament integrity.
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent
breakdown of the skin.
- Known or suspected sensitivity or allergy to one or more of the implant materials.
- Pregnant or considered a member of a protected population (e.g. prisoner, mentally
incompetent, etc.)
- Previously received partial or total knee arthroplasty for the ipsilateral knee.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/11/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
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Accrual to date
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Final
1017
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Fremantle Hospital - West Perth
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Recruitment postcode(s) [1]
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6160 - West Perth
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Bangalore
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Country [2]
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India
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State/province [2]
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Delhi
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Country [3]
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India
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State/province [3]
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Hyderabad
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India
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State/province [4]
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Pune
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Japan
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State/province [5]
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Kochi
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Country [6]
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Japan
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State/province [6]
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Tokyo
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Country [7]
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Korea, Republic of
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State/province [7]
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Gangneung
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Country [8]
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Korea, Republic of
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State/province [8]
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Hwasun
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Country [9]
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Korea, Republic of
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State/province [9]
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Seoul
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Country [10]
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Korea, Republic of
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State/province [10]
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Yangsan
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Country [11]
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New Zealand
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State/province [11]
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Waikato
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Country [12]
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Singapore
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State/province [12]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Zimmer Biomet
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective, multi-centre, non comparative, post market clinical follow-up study
involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included
in this study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04461626
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Myung Chul Lee
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Address
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Seoul National University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04461626
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