Knee Pain ChronicNCT02255383
Persona Total Knee Arthroplasty Outcomes Study
A study testing Zimmer Persona Total Knee System in people with Knee Pain Chronic and Osteoarthritis, run by Zimmer Biomet at 14 sites in United States.
Trial summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Zimmer Persona Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 737 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2014to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18-75 years of age, inclusive
- Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
- Patient has participated in a study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
- Patient is 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 components implanted in accordance with product labeling
Who cannot join
- Patient is 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
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
Show all 12Show fewer
- 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
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
UNC Department of Orthopaedics
Chapel Hill, North Carolina, 27599-7055
OrthoCarolina
Charlotte, North Carolina, 28207
Lindner Research Center
Cincinnati, Ohio, 45219
SportsMedicine Grant & Orthopaedic Associates
Columbus, Ohio, 43215
Colorado Joint Replacement
Denver, Colorado, 80210
Orthopaedic & Spine Center of the Rockies
Fort Collins, Colorado, 80525
Tennessee Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, 37930
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Henry County Orthopedics and Sports Medicine
New Castle, Indiana, 47362
Denver-Vail Orthopedics
Parker, Colorado, 80134
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Raleigh Orthopaedic Clinic
Raleigh, North Carolina, 27612
Rockford Orthopedic Associates
Rockford, Illinois, 61114
Jordan Young Institute
Virginia Beach, Virginia, 23462-1784
About this study
Official title: Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.
Read the detailed description
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Moderate Varus, Valgus or Flexion Deformities
- Being tested
- Zimmer Persona Total Knee System
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Genu Valgum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Persona Total Knee SystemDevice
Also called Total Knee Arthroplasty, Total Knee Replacement
Primary Total Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| PERSONA TKA | Other | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System Receives: Device: Zimmer Persona Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Knee Society Score
Measured: 10 years
Secondary outcomes (1)
EQ-5D
EQ-5D
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255383
- Sponsor's protocol ID
- CSU2014-02K
- Status last verified
- Nov 2024
- First submitted
- 29 Sep 2014
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System
- ClinicalTrials.gov ID
- NCT02255383
- Acronym / sponsor ID
- CSU2014-02K
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Moderate Varus, Valgus or Flexion Deformities
- Keywords
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2014 (estimated)
- 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.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.
Detailed description
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PERSONA TKA | Other | Device: Zimmer Persona Total Knee SystemPrimary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient 18-75 years of age, inclusive
- Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
- Patient has participated in a study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
Key exclusion criteria (12 listed)
- Patient is 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 |
|---|---|---|
| Zimmer Persona Total Knee SystemAlso: Total Knee Arthroplasty, Total Knee ReplacementPrimary Total Knee Arthroplasty | Device | PERSONA TKA |
Primary outcome
Knee Society Score
Time frame: 10 years
Knee Society Score
1 secondary outcome
EQ-5D
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer Persona Total Knee System in people with Knee Pain Chronic and Osteoarthritis, run by Zimmer Biomet at 14 sites in United States.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Knee Society Score (time frame: 10 years). 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 10 Mar 2026.