Knee OsteoarthritisNCT04461626
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Zimmer Biomet at 18 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)
- Type of treatment
- Medical device
- How many people
- 1,017 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 19 Nov 2014to 21 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of patients who require primary TKA and satisfy eligible criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the Persona fixed bearing knee system.
Who may be able to join
- 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:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/ or avascular necrosis of femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus or flexion deformities.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
South Korea8 sites
GangNeung Asan Hospital
Gangneung, 25440
Chonnam National University Hwasun Hospital
Hwasun, 58128
Chungang University Hospital
Seoul, 06973
Seoul National University Hospital
Seoul, 110-460
Seoul St. Mary's Hospital
Seoul, 137-701
Samsung Medical Center
Seoul, 138-736
Seoul Asan Medical Center
Seoul, 138-736
Pusan National University Yangsan Hospital
Yangsan, 50612
India5 sites
Fortis Health Care, Bangalore
Bangalore, 560076,
Sant Parmanand Hospital
Delhi, 110 054
All India Institute of Medical Sciences
Delhi, 110029
Landmark Hospitals
Hyderabad, 500085
Deenanath Mangeshkar Hospital
Pune, 411004
Japan2 sites
Kochi University Hospital
Kochi, 783-8505
Nihon University Hospital
Tokyo, 101-8309
About this study
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.
Read the detailed description
The objectives of the study are to document the implant survivorship and clinical outcomes data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA). The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.
- Conditions
- Knee Osteoarthritis
- Being tested
- Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)Device
| Study group | Role | What they receive |
|---|---|---|
| Persona fixed bearing knee system | Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system) Receives: Device: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
Measured: Up to 5 years post surgery
Adverse Events (Safety)
Safety based on incidence and frequency of adverse events
Measured: Up to 5 years post surgery
Clinical Performance
Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score
Measured: Up to 5 years post surgery
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
Measured: Up to 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start19 Nov 2014
- Primary completion30 Jun 2023
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Chul Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461626
- Sponsor's protocol ID
- CSA2014-02K
- Status last verified
- Aug 2022
- First submitted
- 1 Jul 2020
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04461626
- Acronym / sponsor ID
- CSA2014-02K
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2014 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objectives of the study are to document the implant survivorship and clinical outcomes data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA). The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persona fixed bearing knee system | – | Device: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients who require primary TKA and satisfy eligible criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the Persona fixed bearing knee system.
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system) | Device | Persona fixed bearing knee system |
Primary outcome
Implant Survivorship
Time frame: Up to 5 years post surgery
Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
Adverse Events (Safety)
Time frame: Up to 5 years post surgery
Safety based on incidence and frequency of adverse events
Clinical Performance
Time frame: Up to 5 years post surgery
Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score
Clinical Performance
Time frame: Up to 5 years post surgery
Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Chul Lee principal investigator
Seoul National University Hospital
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Zimmer Biomet at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea, India, Japan, Australia, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship (time frame: Up to 5 years post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.