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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04461626




Registration number
NCT04461626
Ethics application status
Date submitted
1/07/2020
Date registered
8/07/2020
Date last updated
8/07/2020

Titles & IDs
Public title
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
Scientific title
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
Secondary ID [1] 0 0
CSA2014-02K
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant Survivorship - Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
Timepoint [1] 0 0
Up to 5 years post surgery
Primary outcome [2] 0 0
Adverse Events (Safety) - Safety based on incidence and frequency of adverse events
Timepoint [2] 0 0
Up to 5 years post surgery
Primary outcome [3] 0 0
Clinical Performance - Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score
Timepoint [3] 0 0
Up to 5 years post surgery
Primary outcome [4] 0 0
Clinical Performance - Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee
Timepoint [4] 0 0
Up to 5 years post surgery

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.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fremantle Hospital - West Perth
Recruitment postcode(s) [1] 0 0
6160 - West Perth
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Bangalore
Country [2] 0 0
India
State/province [2] 0 0
Delhi
Country [3] 0 0
India
State/province [3] 0 0
Hyderabad
Country [4] 0 0
India
State/province [4] 0 0
Pune
Country [5] 0 0
Japan
State/province [5] 0 0
Kochi
Country [6] 0 0
Japan
State/province [6] 0 0
Tokyo
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Gangneung
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Hwasun
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Yangsan
Country [11] 0 0
New Zealand
State/province [11] 0 0
Waikato
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04461626
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Myung Chul Lee
Address 0 0
Seoul National University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications