OsteoarthritisNCT03034811
Persona Partial Knee Clinical Outcomes Study
A study testing Persona Partial Knee system in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 24 sites in 10 countries.
Trial summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- What is being tested?
- Persona Partial Knee system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 757 participants
- Where
- 24 sitesin 10 countries
- Study dates
- 8 Feb 2017to Sep 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age
- Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.
- 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/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 the commercially available Persona Partial Knee, implanted in accordance with product labeling
Who cannot join
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Infection, sepsis, and osteomyelitis
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
- Full thickness damage to the weight bearing area of the contralateral compartment
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
Show all 17Show fewer
- Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, neuromuscular disease
- Incomplete or deficient soft tissue surrounding the knee
- Charcot's disease
- Fixed varus deformity (not passively correctable) of greater than 15 degrees
- Fixed flexion deformity (not passively correctable) of greater than 15 degrees
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Trial locations and contacts
24 sites in 10 countries.
24 sites in 10 countries
United States9 sites
New Mexico Orthopaedics
Albuquerque, New Mexico, 87106
Sports Medicine North
Beverly, Massachusetts, 01960
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina, 29201
Sah Orthopaedic Associates
Fremont, California, 94538
Panorama Orthopedics & Spine Center
Golden, Colorado, 80401
Skagit Regional Clinics-Riverbend
Mount Vernon, Washington, 98273
Henry County Orthopedics and Sports Medicine
New Castle, Indiana, 47362
Troy Orthopaedic Associates
Troy, Michigan, 48084
Germany3 sites
Hessing Stiftung
Augsburg
Sana Kliniken Sommerfeld
Berlin
Waldkrankenhaus Eisenberg
Eisenberg
United Kingdom3 sites
Avon Orthopaedic Centre, Southmead Hospital
Bristol
Royal Derby Hospital
Derby
Harrogate and District NHS Foundation Trust
Harrogate
France2 sites
Marseille University-Hospital Centres
Marseille
Public Hospital of Versailles
Versailles
Italy2 sites
Orthopedic Institute IRCCS
Milan
Fondazione IRCCS Policlinico San Matteo
Pavia
About this study
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
Read the detailed description
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. 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 partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the 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
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Conditional Tibial Condyle or Plateau Fractures, Conditional Revision of the Articular Surface
- Being tested
- Persona Partial Knee system
- Keywords
- Noninflammatory degenerative joint disease, Osteoarthritis, Avascular necrosis, Traumatic arthritis, Partial knee arthroplasty, Unicompartmental knee arthroplasty
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona Partial Knee systemDevice
Fixed bearing partial knee
| Study group | Role | What they receive |
|---|---|---|
| PPK subjects | Other | Subjects that receive the Persona Partial Knee system Receives: Device: Persona Partial Knee system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
A Patient reported functional outcome score for knee arthroplasty
Measured: 10 years
Secondary outcomes (1)
EQ-5D
a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.
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 posted27 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034811
- Sponsor's protocol ID
- K.CR.I.G.16.16
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persona Partial Knee Clinical Outcomes Study
- ClinicalTrials.gov ID
- NCT03034811
- Acronym / sponsor ID
- K.CR.I.G.16.16
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Conditional Tibial Condyle or Plateau Fractures, Conditional Revision of the Articular Surface
- Keywords
- Noninflammatory degenerative joint disease, Osteoarthritis, Avascular necrosis, Traumatic arthritis, Partial knee arthroplasty, Unicompartmental knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 27 Jan 2017 (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 the commercially available Persona Partial Knee System.
Detailed description
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. 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 partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the 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 |
|---|---|---|
| PPK subjects | Other | Device: Persona Partial Knee systemSubjects that receive the Persona Partial Knee system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is at least 18 years of age
- Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.
- 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/EC approved Informed Consent form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
Key exclusion criteria (17 listed)
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Infection, sepsis, and osteomyelitis
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
- Full thickness damage to the weight bearing area of the contralateral compartment
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 Partial Knee systemFixed bearing partial knee | Device | PPK subjects |
Primary outcome
Oxford Knee Score
Time frame: 10 years
A Patient reported functional outcome score for knee arthroplasty
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 22 Apr 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.
Hillary Overholser study director
Zimmer Biomet
24 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persona Partial Knee system in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 24 sites in 10 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 6 inclusion and 17 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany, United Kingdom, France, Italy and 5 more countries. 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?
Oxford Knee 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 22 Apr 2026.